FENARIMOL Summary Environmental transport, distribution, and transformation Environmental levels and human exposure Effects on organisms in the environment Terrestrial vertebrates Aquatic organisms Bees and other arthropod species Earthworms Microorganisms Environmental effects Identity, physical and Chemical properties, mode of action, and use Identity Physical and chemical properties Formulations Mode of action Use Environmental transport, distribution, and transformation Volatilization and aerial transport Water Hydrolysis Photolysis Persistence in surface water Degradation by microorganisms Bioaccumulation and biomagnification Soil Adsorption and desorption Photolysis Biotransformation Degradation by microorganisms Persistence Bioaccumulation and biomagnification Environmental levels Air Water Soil Effects on other organisms in the laboratory and the field Laboratory and field experiments Microorganisms Aquatic organisms Terrestrial organisms Risk assessment based on agricultural use Microorganisms Aquatic organisms Terrestrial organisms Evaluation of effects on the environment Risk assessment Further research Previous evaluations by international bodies References 1. Summary 1.1 Environmental transport, distribution, and transformation Fenarimol is persistent in soil in laboratory studies but less so in the field under mid-European conditions. Photolysis was shown to occur on surfaces, but the rate was not quantified. As fenarimol is likely to be applied where a crop canopy exists, photolysis is not considered to be a significant mechanism for subsequent degradation in soil Fenarimol is not mobile and is therefore unlikely to reach water through the soil. Should it reach water by other means, it is stable to hydrolysis but susceptible to rapid photolysis. It also partitions rapidly into sediment, and this is likely to be the major process for removal from the water column. Once it is in the sediment, its degradation is slow. 1.2 Environmental levels and human exposure No data on levels in air or water were provided, but levels in soil reached 0.1-0.4 mg/kg (averaged over the top 20 cm) directly after application of 270 g/ha. In laboratory experiments, the level in fish exposed to 0.1 mg/litre was 14.1 mg/kg tissue, and those in earthworms exposed to 1 and 10 mg/kg soil were 1.0 and 9.6 mg/kg tissue, respectively. 1.3 Effects on organisms in the environment 1.3.1. Terrestrial vertebrates Birds and mammals are thought to be exposed to fenarimol mainly from feeding, either directly on grass or fruit treated with fenarimol or by eating contaminated insects or earthworms present in fenarimol-treated crops. As fenarimol generally has low toxicity for birds (LD50 > 2000 mg a.i./kg bw) and mammals (LD502500 mg a.i./kg bw), the toxicity:exposure ratios (TERs) were above the threshold for unacceptable effects set by the European Plant Protection Organisation (EPPO) (1993), indicating that use of fenarimol should present a low acute risk to wild birds and mammals. Reproducing birds are thought to be exposed to fenarimol only when multiple applications are made in orchards throughout the year. On the basis of a revised NOEC of 50 mg/litre for reproductive toxicity, the TERs for this end-point were above the EPPO threshold for unnacceptable effects and indicate that the risk to reproducing birds of use of fenarimol in orchards should be low. 1.3.2 Aquatic organisms Technical-grade fenarimol and fenarimol-containing products had moderate acute toxicity to aquatic organisms, with LC50 and EC50 values of 0.82 mg a.i./litre for the most sensitive fish species tested, 0.18 mg a.i./litre for aquatic invertebrates, and 0.76 mg a.i./litre for algal species. On the basis of these data, formulations of fenarimol are classified as 'harmful to fish or other aquatic life'. Worst-case assessments for over-spraying indicated that there is an acute risk (TER < 100) to all three aquatic groups from the use of fenarimol, particularly its use on turf and in orchards. An assessment of spray drift indicated, however, that the risk to aquatic life from use on turf was acceptable, particularly when a dissipation half-life (DT50) of < seven days for fenarimol in the aqueous phase of water and sediment systems was taken into account. Although this assessment indicates that the acute risk to fish and algae from the remaining agricultural and horticultural uses is also acceptable, aquatic invertebrates are at acute risk from contamination arising from air-assisted spray application, such as used in orchards. Fenarimol was also of moderate long-term toxicity to fish and aquatic invertebrates, with NOECs of 0.43 and 0.113 mg a.i./litre, respectively. After overspraying on turf and in agricultural and horticultural uses of fenarimol, fish and aquatic invertebrates have a high long-term risk (TER < 10), particularly from use on turf and in orchards. An assessment of spray drift after use on turf indicated, however, that the long-term risk to fish and aquatic invertebrates was acceptable, when a DT50 of < 7 days for fenarimol in the aqueous phase of water-sediment systems was taken into account. Although fenarimol was rapidly removed from the aqueous phase of natural water-sediment systems, it partitioned and persisted in the sediment phase. Sediment-dwelling invertebrates (Daphnia magna) may be at long-term risk from the use of fenarimol by air-assisted spray application to tree and bush crops, such as in orchards. 1.3.3 Bees and other arthropod species Fenarimol had little acute toxicity to honey bees, the acute oral LD50 being > 10 µg a.i./bee and the contact LD50 being > 100 µg a.i./bee. Although the hazard ratio for turf use, < 150, may have exceeded the EPPO threshold of 50, the risk to bees from this use was considered to be low, as application was done mainly in autumn or winter when bees are unlikely to forage. The hazard ratios for the remaining uses were < 50, indicating low risk to bees. As the recommended European Standard Characteristics of Beneficial Regulatory Testing for non-target arthropods were not satisfied, the data that were submitted could not be used to assess the risk to non-target arthropods from agricultural use of fenarimol. 1.3.4 Earthworms Fenarimol had little toxicity for earthworms, with an acute LC50 of 200-300 mg a.i./kg soil and a reproductive NOEC of 1890 g a.i./ha. In a number of overspray assessments, the acute and sublethal risks to earthworms of application to turf and multiple applications in orchards at maximal rates were considered to be low. 1.3.5 Microorganisms Fenarimol had no effect on soil respiration and nitrification processes at application rates up to 28 times the recommended maximum. Representative 'worst-case' multiple overspraying of turf and orchards at the maximal application rate resulted in a low risk to soil microorganisms from the use of fenarimol. Concentrations up to 102.4 mg/litre had no effect on sewage treatment processes, indicating a low risk. 1.4 Environmental effects Fenarimol is not mobile but is persistent. Under normal conditions of use on foliage, the amount that actually reaches the soil is likely to be significantly reduced. As the potential risk to aquatic invertebrates can be reduced by introducing a buffer zone, use of fenarimol should present a low risk to non-target organisms. 2. Identity, physical and chemical properties, mode of action, and use 2.1 Identity ISO common name: fenarimol Chemical name IUPAC: (±)-2,4-dichloro-alpha-(pyrimidin-5-yl) benzhydryl alcohol Chemical Abstracts: (±)-alpha-(2-chlorophenyl)-alpha- (4-chlorophenyl)-5-pyrimidinemethanol CAS Registry No: 60168-88-9 (unstated steriochemistry) CIPAC No: 380 Synonyms: compound 5732; development code EL-222 Structural formula:Molecular formula: C17H12Cl2N2O Relative molecular mass: 331.2 2.2 Physical and chemical properties Pure active ingredient Vapour pressure: 6.5 × 10-5 Pa at 25°C (99.7% pure) Hydrolysis At 25, 37 and 52°C: (no purity stated)pH 3 no hydrolysis pH 6 no hydrolysis pH 9 no hydrolysis After reflux at 100°C for 40 h pH 3 30% hydrolysis pH 6 no hydrolysis pH 9 13% hydrolysis Photolysis (no purity stated) Natural sunlight: half-life in 2 mg/litre aqueous solution in summer sun, 12h half-life in water in laboratory-simulated sunlight, < 1 h half-life on silica gel plates in sunlight approx. 14 h Laboratory irradiation: half-life in distilled water, 0.6 h half-life in 2% acetone-water, 2.0 h No information was submitted on melting-point, octanol-water partition coefficient, solubility, or specific gravity. Technical material Purity: typically > 97%, with certified limits of 95-101% to allow for assay and production variability. Impurities < 0.5%, except for 2,2'-, 2,3'-, and 4,4'-dichloro isomers, total max. 3% Colour: off-white to buff Physical state: crystalline solid Odour: slightly aromatic Melting point: 117-119°C Octanol-water partition log Kow = 3.69 coefficient: Solubility (mg/litre at 25°C; purity either 95.4% or unspecified) water at pH 3 14.6 water at pH 7 13.7 water at pH 10 13.8 acetone >250 acetonitrile 40-45 benzene 100-125 chloroform > 500 cyclohexanone > 500 ethyl cellulosolve > 250 heavy aromatic naphtha 40-45 hexane 1.1 methanol 100-125 methyl cellulose > 250 xylene 40-45 (A 09 & A 14) Packed bulk density: 0.7-0.8 kg/m3 2.3 Formulations Fenarimol is formulated mainly as wettable powders, emulsifiable concentrates (EC) or suspension concentrates (SC). 2.4 Mode of action Fenarimol inhibits ergosterol biosynthesis by inhibing C14 demethylation. 2.5 Use Fenarimol is a systemic fungicide, which protects, cures, and eradicates. It is usually applied to leaves and moves apoplastically through the leaf towards the tip. Movement from treated to untreated leaves is not significant enough to control disease. Application to roots and seeds results in translocation to all of the aerial parts of the plant. Fenarimol is registered in many countries for use on a wide range of fruits, vegetables, hops, and wheat, at application rates of 0.005-0.2 kg/ha on fruit with up to 14 applications per season, 0.002-0.06 kg/ha on vegetables with 1-10 applications per season, < 1.5 kg/ha on turf with one to four applications per season, and 0.04-0.06 kg/ha on cereals and hops with one to four applications per season. 3. Environmental transport, distribution, and transformation 3.1 Volatilization and aerial transport The dimensionless Henry's law constant (air-water partition coefficient) for fenarimol is 2.83 × 10-7, indicating that it has moderately low volatility. The volatilization of fenarimol from plant and soil surfaces was investigated by Day (1993). Formulated fenarimol was sprayed onto Borstel soil at 60% maximal water-holding capacity or onto stands of French beans about 30 cm high covering 70-80% of the soil, at a rate of 70 g a.i./ha. The temperature was maintained at 20°C, with a relative humidity of 40% and an air velocity of 1.2 m/s. Less than 0.2% radioactivity was volatilized from the soil and 1.5% from the plants. 3.2 Water 3.2.1 Hydrolysis Fenarimol in sterile buffer solutions at pH 3, 6 or 9 was incubated in the dark at 25, 37, or 52°C for four weeks. No degradation occurred. When the solutions were refluxed at 100°C for 40 h, about 30% hydrolysis occurred at pH 3 and 13% at pH 9 (Anon., undated). Thus, fenarimol is stable to hydrolysis. 3.2.2 Photolysis Aqueous solutions of fenarimol and silica plates coated with fenarimol were subjected to artificial light or natural summer sunlight at 40° N in the USA. The first-order half-lives were < 13 h under all conditions. Similar results were obtained by Mosier & Saunders (1976) and Smith & Saunders (1982a), who also reported that the major metabolite is 2'-chloro-2-(5-pyrimidyl)-4-chloro-benzo- phenone. Saunders (1991) calculated the quantum efficiency of photolysis and predicted half-lives ranging from 0.93 days in summer at 30° N to 5.3 days in winter at 50° N. Fenarimol is thus susceptible to rapid photolysis, but the significance of this process in turbid waters is uncertain. 3.2.3 Persistence in surface water Fenarimol may reach surface waters by spray drift, direct overspray, or erosive run-off of water or particulate matter. Rapid photolysis is a possible mechanism of degradation, but this may not occur in turbid waters. In natural water-sediment systems in the dark, fenarimol partitioned rapidly into the sediment (75-80% within seven days), with a partition DT50 of < 7 days, a DT90 of < 14 days (re-calculated from raw data), and no appreciable degradation over 80 days (Jackson & Lewis, 1994a). In a study conducted outdoors in the USA, a slower rate of partitioning from water to sediment was seen (DT50, 18 days; re-calculated from raw data) (Althaus & Goebel, 1981). This value does not agree with the probable photolysis rate or the results of the previous study; since the study was conducted in 1981, the result is considered to be less reliable. In general, irrespective of the route of entry of fenarimol into surface water, it will be adsorbed onto sediment and persist, as its degradation is slow. 3.2.4 Degradation by microorganisms No data were submitted on the degradation of fenarimol by microoganisms in aqueous systems. It was not degraded during a semi-continuous, 28-day study of aerated sewage sludge (Kline & Knox, 1981). 3.2.5 Bioaccumulation and biomagnification In a 14-day study of bioaccumulation under static conditions, bluegill sunfish (Lepomis macrochirus) were exposed for seven days to a mean measured concentration of 0.083 mg/litre fenarimol (Althaus & Beaty, 1981; Althaus, 1983). The maximal plateau concentrations were 5.1 mg/kg fenarimol in muscle after one day, 14.1 mg/kg in carcass after four days, and 9.1 mg/kg in whole fish after two days, equivalent to bioconcentration factors of 60,175, and 113 for muscle, carcass, and whole fish, respectively. Depuration after transfer to uncontaminated water was biphasic, with DT50 values of 0.6 day for the first three days of depuration and 5.5-6.1 days for the last four days. Overall, > 95% of radioactivity was eliminated within four days. 3.3 Soil 3.3.1 Adsorption and desorption The Koc values for fenarimol in four soils with 0.3-1.2% organic carbon, pH 5.7-7.7, and a clay content of 5-32%, were 500-992 for adsorption and 482-2468 for desorption (re-calculated from the raw data, since organic matter content was not converted to organic carbon content in the original report) (Saunders & Powers, 1987). In studies of four representative soils, with organic carbon contents of 0.6-2%, pH 5.6-8.1, and clay contents of 4-28%, radiolabelled fenarimol was applied to 30-cm dry soil columns, which were then leached with 64 cm water for two to four days. Only 0-0.4% of the total radiolabel was found in the leachate, and 91-100% remained in the top 10 cm of soil. For comparison, 3.4-43% of atrazine was found in the leachate from the same soils and the compound was spread evenly throughout the soil (Sullivan & Saunders, 1976). When soil (organic carbon, 0.6-1.8%; pH 6.4-8.1; clay content, 4-33%) containing fenarimol was aged for 30 days and then placed on the tops of four columns which were then leached with 51 cm water, unidentified radiolabel in the leachate accounted for 0.24-0.32%, and essentially all of the radiolabel was in the top 12 cm of soil (Saunders et al., 1983). After 50 h photolysis of fenarimol in soil in natural sunlight, 46% of the radiolabel was identified as fenarimol. Portions of the treated soil (organic carbon, 1.7-2.5%; pH 5-7.5; clay content, 4-21%) were placed on two columns which were then leached with 30 cm water over three days. The leachate contained 1.7-9% of the radiolabel, and 80-92% remained in the top 5 cm of the column. The main component of the leachate was ortho-chlorobenzoic acid (34-50% of the radiolabel); the remainder was a complex mixture of very polar compounds (Vonk & van den Hoven, 1981). 3.3.2 Photolysis Conflicting results have been obtained with regard to the photolysis of fenarimol in soil, perhaps due to differences in incident light or the nature of the surface. The fate of a thin film of fenarimol in a pan in sunlight for 18 h and of a dry deposit under the same conditions for 200 h was studied in Indiana, USA, at a maximal temperature of 37°C: 62% of the fenarimol remained after 18 h and only 4% after 200 h. Numerous minor degradation products were found; the primary breakdown pathways were reported to be oxidation of the chlorobenzene rings and the carbinol carbon. Secondary pathways were ring closure, ring migration, and reduction of the carbinol carbon (Althaus & Bewley, 1978a). In a study of the photolysis of a dry deposit of fenarimol in a pan in natural winter sunlight in Indiana, USA, with a maximal temperature of 18°C), 33-38% remained after 100 days, and the major metabolite was ortho-chlorobenzoic acid (Althaus, 1984). In a further study of the photolysis of fenarimol on a soil film in natural sunlight in Indiana, USA, for up to 32 h, no degradation was observed (Smith & Saunders, 1982b). 3.3.3 Biotransformation Three agricultural soils and one standard soil (organic carbon, 0.8-2.5%; pH 5.2-7.7; clay content, 6-39%) were incubated with fenarimol at 0.05 or 0.25 mg/kg, 40% maximal water-holding capacity, and 20°C. Fenarimol degraded very slowly, with DT50 values of 436-1833 days, according to first-order kinetics (Jackson & Lewis, 1994b). Similar results were obtained in a study in which a single metabolite, alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-1,2- dihydro-2-oxo-5-pyrimidinemethanol, was identified (Rainey, 1990). In a brief comparison of aerobic and anaerobic degradation, both aerobic and anaerobic metabolism were found to be slow, in keeping with other results (Althaus & Beaty, 1982). Slow anaerobic degradation had been observed previously (Althaus & Bewley, 1978b). 3.3.4 Degradation by microorganisms Microbial degradation has not been addressed directly, but given the very slow degradation of fenarimol under aerobic and anaerobic conditions, a significant change in degradation rate is unlikely to be seen in sterile soil. 3.3.5 Persistence As discussed above, the degradation of fenarimol incubated in the laboratory at 20°C is very slow, and the half-lives apparently vary widely. The wide range is probably due to inaccuracies in calculations, owing to the degree of extrapolation required to reach a half-life. Nevertheless, the compound is clearly very persistent in soil under laboratory conditions. Studies of dissipation at agricultural sites in Germany gave much shorter DT50 values (18-140 days), but the DT90 values were still in excess of one year. 3.3.6 Bioaccumulation and biomagnification In a 21-day study of bioaccumulation in earthworms, Lumbricus terrestris were exposed to technical-grade fenarimol for 14 days in a mixture of soil and rabbit faeces (for food source) at concen- trations of 0, 1, or 10 mg/kg soil, followed by a seven-day clearance period in uncontaminated soil. The mean concentrations of fenarimol in soil were 111-150% of the nominal level. The concentrations in the earthworms never exceeded the surrounding soil concentration, with levels of 0.027 mg/kg bw after 1 h, 0.957 mg/kg bw after seven days, and 1.037 mg/kg bw (to a maximum of 69% of the measured soil concen- tration) after 14 days of exposure to a nominal soil concentration of 1 mg/kg soil. Similarly, the concentrations of fenarimol in earthworms exposed for 1 h or seven or 14 days to a nominal soil concentration of 10 mg/kg soil were 0.105, 8.26, and 9.645 mg/kg bw (to a maximum of 89% of the measured soil concentration), respectively. These results indicate that fenarimol was not bioaccumulated in earthworms at concentrations above that in the soil. Earthworms rapidly eliminated residues of fenarimol on transfer to uncontaminated soil, with a clearance DT50 of five days (Hoffman et al., 1981). 4. Environmental levels 4.1. Air No data were available. 4.2 Water No data were available. 4.3 Soil An EC formulation of fenarimol was sprayed at a rate of 270 g a.i./ha onto bare soil containing 1.2-4.9% organic carbon, pH 5.6-7.3, and 9-26% clay, at four German agricultural field sites in May 1990, and fenarimol was analysed in a 0-20-cm deep segment. The DT50 was 14-123 days and the DT90, 120-> 610 days (recalculated from the observed raw data rather than by curve fitting); however, uncertainty about the results obtained at the early sampling times reduces the confidence that can be placed in the DT50 value (Perkins, 1993). In a further trial in which an EC formulation of fenarimol was sprayed at a rate of 270 g a.i/ha onto bare soil containing 0.9-1.1% organic carbon, pH 4.8-5.7, and 12-21% clay) at two German agricultural field sites in May 1992, the concentrations in the 0-20-cm layer on clay 0 were 0.076-0.082 mg/kg. The resulting dissipation DT50 value was 60-130 days and the DT90 was 489-> 609 days (recalculated from the observed raw data rather than by curve fitting) (Butcher & Rawle, 1994). The effect of surface application or incorporation of fenarimol onto or into a silt loam soil was studied in Indiana, USA. When fenarimol was applied to the surface, the dissipation DT50 was 112 days and 35% remained after 511 days. When fenarimol was incorporated into soil, none was dissipated from the 0-15-cm soil layer, and 65% of the applied fenarimol remained after 903 days. Fenarimol is generally applied to foliage, however, and hence dissipation rates after soil incorporation are probably of little practical relevance (Althaus & Bewley, 1978b). 5. Effects on other organisms in the laboratory and the field 5.1 Laboratory and field experiments 5.1.1 Microorgansims (a) Water In a semi-continuous, 28-day study of aerated sewage, the effect of technical-grade fenarimol at concentrations up to 102.4 mg/litre on microorganisms and the effect of microorganisms on fenarimol were investigated (Kline & Knox, 1981). Fenarimol had no effect on biological oxygen demand, viable cell count, pH, or accumulation of solids in sewage inoculum, and it was not significantly degraded. Fenarimol at these concentrations therefore had no effect on sewage treatment processes. (b) Soil In a 14-week study, the effect of fenarimol at 240 mg/kg soil was studied on respiration and microbial populations in a loam, a sandy loam, muck, and a greenhouse mixture (Kline & Knox, 1976). Slight reductions in comparison with controls were seen in carbon dioxide production in the loam (about 22% reduction) and greenhouse soils (about 40% reduction), but no effect was seen in the sandy loam or muck soils. There was no difference in the number of colony forming units in treated and control soils, except for an initial reduction in the number of soil fungi in the treated loam and sandy loam, both of which recovered to control levels within four to six weeks. In a 15-day study, the effect of technical-grade fenarimol at 0, 0.4, 2, or 10 mg/litre was observed on nitrifying microorganisms (Peloso & Kline, 1982). Oxidation of ammonium to nitrite by Nitro- somonas europaea was nearly complete at all test concentrations and in the control by day 25. There was a slight enhancement of nitrif- ication at 0.4 and 2 mg/litre fenarimol, whereas at 10 mg/litre there was either no effect or slight enhancement of nitrification of ammonia. Complete oxidation of nitrite to nitrate by Nitrobacter winogradskyi had occurred by day 12 after treatment with 0, 0.4, or 2.0 mg/litre fenarimol; at 10 mg/litre, a further three days were necessary to achieve the same level of nitrification. In a 28-day study conducted according to German Biologische Bundesanstalt fur Landund Forstwirtschaft (BBA) Guideline VI 1-1, the effect of a 120 g/litre EC formulation of fenarimol on soil microflora activity in a loamy sand and silty loam soil was investigated at application rates equivalent to 36 or 504 g/ha (Todt et al., 1988). After 14 days, the dehydrogenase activity of all treated soils was lower (2.4-2.5 mg triphenyl formazene per 100 g dry soil weight) than that in the untreated control (3.5-4.3 mg triphenyl formazene per 100 g dry soil weight). The decrease was thus not dependent on the application rate. The dehydrogenase activity of both soils returned to control levels by day 28. There was no significant difference between control and fenarimol-treated soils in nitrification activity, as measured by soil nitrite content; however, the amount of newly formed nitrate in both soils was twice that expected from the nitrite depletion. As this effect was also reported in the control, it was considered not to be related to treatment. 5.1.2 Aquatic organisms (a) Plants The acute toxicity of fenarimol to aquatic green algae is summarized in Table 1. In addition, McCowen (1982) reported that technical-grade fenarimol at concentrations up to 10 mg/litre had no effect on cultures of Chlorella pyrenoidosa, Scenedesmus obliquus, or Anacystis nidulans. The highest concentration had a moderate effect on Raphidocellis subcapitata. (b) Invertebrates The acute toxicity of fenarimol to aquatic invertebrates is summarized in Table 2. In a 21-day life cycle test under static conditions, Daphnia magna were exposed to technical-grade fenarimol at nominal concentrations of 0.113-1.084 mg/litre, giving actual concentrations of 107-113% of the nominal value. Parental survival was 90-100% in water controls and at 0.113-0.331 mg/litre fenarimol but dropped to 70% at 0.643 mg/litre and 10% at 1.084 mg/litre. Statistically significant reductions were seen in the numbers of broods, of 4.8-4.9 in controls to 0-4.0 at > 0.219 mg/litre fenarimol, in the total number of young per female, from 103.2-105.2 in controls to 0-86.1 at > 0.331 mg/litre fenarimol, and in mean body length, from 4.13- 4.24 mm in controls to 3.4-3.82 at > 0.643 mg/litre fenarimol. The NOEC, in mean measured test concentrations, was therefore 0.113 mg/litre (Hoffman et al., 1987). (c) Vertebrates The acute toxicity of fenarimol to fish is summarized in Table 3. The chronic toxicity of technical-grade fenarimol to fathead minnows (Pimephales promelas) was investigated in a 33-day test during the early life stage in a flow-through system. By the end of the study, 97-99% of eggs had hatched and 92-97% of fish in all groups were alive. There were no physical or behavioural signs of toxicity and no significant effects on fish length or weight throughout the study at any concentration. The actual test concentrations were reported to be 92-100% of the nominal value. The NOEC as a mean measured test concentration was 0.98 mg/litre, the highest dose tested (Hoffman et al., 1982a). Table 1. Acute toxicity of fenarimol to aquatic green algae Organism Study type Exposure (% of End-point, result Test Reference nominal concn) (mg/litre) guideline Value 95% CI Raphidocellis Static 76-100% a.i.; 14 days LC50 = 1.48a 0.63-20.0 None (broadly Hoffman & subcapitata (32% at 1.5 mg/litre) in line with Cocke (1988) OECD 210) Scenedesmus Static 94-104%; a.i ErC50 24-48 h = 3.8 3.5-4.2 OECD 201 Douglas et al. subspicatus EbC50, 72 h = 3.0 2.7-3.3 (1991) EbC50, 96 h = 5.1 4.5-5.9 NOEC = 0.59 Raphidocellis Static 94-106% at 24 h; Eb50, 72 h = 0.76 0.59-0.96 OECD 201 Bell (1994a) subcapitata 120 g/litre EC NOEC = < 0.12 formulation Er50, 72 h = 1.32 1.14-1.44 NOEC = 1.2 CI, confidence interval; EbC, effective concentration for effect on biomass; ErC, effective concentration for effects on growth rate a Based on measured test concentrations Table 2. Acute toxicity of fenarimol to aquatic invertebrates Organism Study type Exposure (% of End-point, result Test Reference nominal concn) (mg/litre) guideline Value 95% CI Daphnia magna Static A.i.; not measured None (broadly Karnak et al. 24 h LC50 = > 10 in line with EC (1978a) 48 h LC50 = 6.8 method C2) NOEC = < 2.75 Daphnia magna Static 92-110%; 120 g/litre EC method C2 Bell (1994b) SC formulation (equivalent to 24 h LC50 = 0.32 0.29-0.37 OECD 202) 48 h LC50 = 0.18 0.12-0.26 NOEC = 0.12 Daphnia magna Static 86-109%; 120 g/litre EC method C2 Douglas et al. SC formulation (equivalent to (1993) 24 h LC50 = 5.6 4.6-7.1 OECD 202) 48 h LC50 = 1.4 1.2-1.7 NOEC = 0.2 CI, confidence interval; SC, suspension concentrate In a 69-day test during the early life stage in a flow-through system with rainbow trout (Oncorhynchus mykiss) exposed to technical- grade fenarimol, 96-100% of the eggs hatched and 92-100% of the fish were still alive 30 days after hatching. Survival 59 days after hatching was reduced to 86% at 0.97 mg/litre (the highest concen- tration), but this was not statistically significant. No behavioural signs of toxicity were reported at any concentration. The mean lengths of fish 30 days after hatching were statistically significantly lower than those of controls in solvent or in water or at 0.43 mg/litre fenarimol. These effects were not considered to be dose-related, however, since there was no statistically significant difference at the same doses 59 days after hatching. The mean lengths of fish at 0.87 mg/litre fenarimol were significantly lower than those of controls 30 and 59 days after hatching, and this effect was considered to be treatment related as it was associated with a statistically significant drop in mean body weight. The NOEC as a mean measured test concentration was 0.43 mg/litre, on the basis of the statistically significant reduction in both mean length and weight at the highest dose. The actual concentrations were reported to be 88-140% of the nominal value (Hoffman et al., 1982b). 5.1.3 Terrestrial organisms (a) Plants No data were available. (b) Invertebrates Bees: Technical-grade fenarimol had little toxicity, with a 48-h oral LD50 of > 10 µg/bee and a 48-h contact LD50 of > 100 µg per bee (Bell, 1994d). Mortality at these doses was < 1% after contact, 23% after 24 h oral exposure, and 25% after 48 h; however, higher oral doses should have been tested. As both the oral and contact LD50 values for fenarimol are > 10 µg per bee, all fenarimol-containing products should remain unclassified in terms of their hazard to honey bees. Other non-target arthropod species: No standard laboratory tests on the toxicity of technical-grade or formulated fenarimol to non-target arthropods were submitted. Primary data on the insecticidal properties of technical-grade fenarimol formulated in an acetone- ethanol mixture diluted with distilled water containing 0.25% Tween 20 (a surfactant), administered as one spray of 400 mg a.i./litre or two sprays of 50 or 400 mg/litre, were, however, submitted (Hertlein et al., 1994). No effect was reported on cotton aphid (Aphis gossypii) or spider mites (Tetranychus urticae) when fenarimol was applied directly to infested plants. Similarly, application of fenarimol to a substrate, followed immediately by a drying period before introduction Table 3. Acute toxicity of fenarimol to fish Organism Study type Exposure (% of End-point, result Test Reference nominal concn) (mg/litre) guideline Value 95% CI Lepomis Flow through 55-86%; a.i.; 186 h 2.74-5.17 (chronic None Kehr et al. (1978a) macrochirus toxicity) Lepomis Static, not 88-95%; a.i. None (broadly Hoffman (1980) macrochirus aerated 24 h > 4.0 in line with 48 h 2.0 1.7-2.5 OECD 203) 72 h 1.8 1.5-2.4 96 h 1.8 1.5-2.4 NOEC = 0.86 Static, aerated 24 h 9.6 5.8-16 48 h 5.7 3.4-9.6 72 h 5.7 3.4-9.6 96 h 5.7 3.4-9.6 NOEC = < 2.1 Oncorhynchus Static, not 92-109% a.i. None (broadly Hoffman (1980) mykiss aerated 24 h > 2.4 in line with 48 h 2.4-4.1 OECD 203) 72 h 2.4-4.1 96 h 3.1 2.4-4.1 NOEC = 0.53 Static, aerated 24 h 4.1 3.2-5.3 48 h 4.1 3.2-5.3 72 h 4.1 3.2-5.3 96 h 4.1 3.2-5.3 NOEC = < 1.1 Table 3. (cont'd) Organism Study type Exposure (% of End-point, result Test Reference nominal concn) (mg/litre) guideline Value 95% CI Oncorhynchus Semi-static 81-109%; 120 g/litre OECD 203 Bell (1994c) mykiss SC formulation (67.4% at 72 h) 24 h 1.8 1.2-2.6 48 h 1.2 0.8-1.7 72 h 0.9 0.7-1.3 96 h 0.8 0.6-1.2 NOEC = 0.3 Oncorhynchus Semi-static 89-102%; 120 g/litre OECD 203 Douglas (1993) mykiss SC formulation (74% at 100 mg/litre) 24 h 6.1 4.9-7.4 48 h 5.0 3.8-6.7 72 h 5.0 3.8-6.7 96 h 5.0 3.8-6.7 NOEC = 0.12 CI, confidence interval of test insects, had no effect on tobacco budworm (Heliothis virecscens), beet armyworm (Spodoptera exigua), German cockroach (Blattella germanica), southern corn rootworm (Diabrotica 11-punctata howardi), or a free-living non-plant parasitic nematode (Pelodera sp). Conflicting results were obtained for the aster leafhopper (Macrosteles severini) in two trials: In the first, one application of fenarimol at 400 mg/litre to the test substrate followed by a drying period resulted in the deaths of all aster leafhoppers, whereas in the second, two similar applications of fenarimol at 50 or 400 mg/litre had no effect. The effect of fenarimol on aster leafhoppers in the first trial may therefore not have been treatment related. Applications of fenarimol at spray concentrations up to 400 mg/litre were thus generally of low toxicity to insects. Fenarimol formulated as a 120 g/litre EC formulation and applied as a 0.014% spray was classified as 'harmless' (< 50% effect in laboratory tests) to beneficial parasites such as Encarsia formosa, Aphidius matricariae, Leptomastix dactylopii, Phygdeuon trichops, and Coccygomimus turionellae, to predatory mites and spiders such as Phytoseiulus persimilis, Amblyseius potentillae, Amblyseius finlandicus, Typhlodromus pyri, and Chiracanthium mildei, and to predatory insects such as Syrphus corollae, Harmonia axyridis, Anthocoris nemoralis, Bembidion lampros, and Pterostichus cupreus. 'Slightly harmful' effects (50-79%) were reported in tests with the parasitoid Trichogramma cacoeciae and the predatory insects Chrysoperla carnea and Semiadalia 11-notata. In semi-field and field studies, the same formulation was classified as 'harmless' (< 25% effect in semi-field tests) for the predatory insects Chrysoperla carnea and Aleochara bilineata and the predatory mites Phyto- seiulus persimilis and Typhlodromus pyri but 'moderately harmful' (51-75%) for the predatory mite Amblyseius finlandicus (Hassan et al., 1988). In a field study conducted in a Belgian orchard, the number of arthropods falling onto plastic sheets in replicate tree plots after treatment with a 120 g/litre EC formulation of fenarimol at a spray concentration of 0.033% (0.5 litre of product in a water volume of 1500 litres/ha) and an application rate of 60 g/ha was compared with the total population in the plots, as the number present on plastic sheets after treatment with dichlorvos. The percentage change in populations of Heteroptera, Dermaptera, Chrysopidae (larvae), Chrysopidae (adults), Coccinellidae (larvae), Coccinellidae (adults), Syrphidae (adults), and Hymenoptera parasitica was reported using 'Steiner's formula'. The highest percentage change was 13.8% for Dermaptera (mainly earwigs); the remaining values were either negative or < 10. Fenarimol at an application rate of about 59.4 g/ha was thus considered to be 'harmless' to the beneficial arthropod fauna of orchards. This study was not conducted according to any recognized standard protocol (Anon., 1991). Earthworms: In a 14-day study, Lumbricus terrestris was exposed to technical-grade fenarimol in a mixture of soil and rabbit faeces (for food source) at concentrations up to 100 mg/kg soil (Karnak et al., 1978b). Fenarimol had little toxicity, since no deaths were reported. Body weight was reduced during the last seven days of the study at all concentrations including the control. This was not considered to be treatment related and was probably due to exhaustion of the food source. In a 14-day test in artificial soil, Eisenia foetida was exposed to a 120 g/litre EC formulation of fenarimol. Little toxicity to compost worms was seen, with an LC50 of 200-300 mg/kg soil, in both the preliminary range-finding and the definitive test. In the preliminary test, no deaths occurred after 14 days' exposure at a concentration of < 100 mg/kg soil, but there was 100% mortality at 500 and 1000 mg/kg. In the final test, 0, 5, 75, 100, and 100% of earthworms died after 14 days' exposure to 100, 200, 300, 400, and 500 mg/kg, respectively. Mean weight losses of 47-62 mg per worm were reported after exposure to concentrations of 100-300 mg/kg, but as a weight loss of 47 mg was reported in the controls and the soil moisture content for all groups fell below the recommended 35%, the body-weight losses were not considered to be treatment-related but probably due to dehydration of the worms. The 14-day NOEC was 100-200 mg/kg soil on the basis of mortality. The study was conducted according to the OECD 207 test guideline (Kühner, 1992). In a 56-day test in artificial soil, the effect of a 120 g/litre EC formulation of fenarimol was observed on the reproduction of the earthworm Eisenia foetida (Bauer & Dietze, 1993). Earthworms were exposed to soil that was sprayed directly with fenarimol at an application rate of 378 or 1890 g/ha. After 28 days, 2.5% mortality was seen at both test concentrations but was not considered to be treatment related. The mean biomass of treated earthworms was not significantly different (3.8-4.4% difference) from that of the control group at day 0 or 28 after treatment. Similarly, the numbers of offspring per surviving adult after 56 days (6.5 and 6.4 at 378 and 1890 g/ha) were not significantly different from that of the control group (6.3). No morphological or behavioural symptoms of toxicity were reported during the trial. Application of this formulation of fenarimol at rates up to 1890 g/ha thus had no effect on the reproduction of Eisenia foetida. The study was conducted according to a draft BBA guideline. (c) Vertebrates Birds: Fenarimol had low acute oral toxicity to bobwhite quail (Colinus virginianus), with an LD50 of > 2000 mg/kg bw and an NOEC of 2000 mg/kg bw (the highest dose tested) (Kehr et al., 1978b). In a poorly reported study of oral toxicity, fenarimol was found to have little acute toxicity to mallard ducks (Anas platyrynchos) or bobwhite quail, with an LD50 of > 200 mg/kg bw (the only dose tested) for both species (Hoffman et al., 1975). Fenarimol was found to have an eight-day LC50 for mallard ducks of > 6250 ppm (Kehr et al., 1978c). The NOEC was reported to be 1250 ppm, on the basis of reduced body weight gain during a three-day recovery phase at the highest dose; however, as reduced food consump- tion resulting in statistically significantly reduced body-weight gain was reported at all concentrations during the five-day exposure period, the NOEC is < 50 ppm (the lowest concentration tested). The eight-day LC50 for bobwhite quail was > 6250 ppm (Kehr et al., 1978d). The NOEC was again reported to be 1250 ppm on the basis of reduced feed intake and a consequential statistically significant reduction in body-weight gain during both the exposure and recovery period at 6250 ppm; however, as a statistically significant reduction in body-weight gain was also reported during the recovery period after 1250 ppm, perhaps indicating a dose-response relationship, the NOEC is 250 ppm fenarimol. In a one-generation study of reproductive toxicity, which was not conducted according to any recognized standard protocol but which broadly conformed to OECD test guideline 206, fenarimol was reported to have little toxicity to mallard ducks, with 4, 16, 4, and 4% of adults dying at 0,10, 50, and 250 ppm fenarimol, respectively (Fink, 1977). As all of the deaths were in females, no dose-response relationship was evident, and no signs of gross abnormalities were seen at necropsy, the effects were considered not to be related to treatment but to the stress of egg laying. No statistically significant effects were seen on reproductive parameters, such as the numbers of eggs laid and cracked, eggshell thickness, viable embryos, live three-week embryos, normal hatchling, and 14-day survivors, at any dose tested. The NOEC was stated to be 250 ppm (the highest dose tested), but the number of eggs laid was reduced by 9.2% at 50 ppm and 27% at 250 ppm; this result may have been dose-related although not statistically significant. As the raw data were not available to confirm whether this reduction was dose-related, the NOEC is in fact 50 ppm, on the basis of the 27% reduction in the number of eggs laid at the highest dose. In a one-generation study of reproductive toxicity, which was not conducted according to any recognized standard protocol but which broadly conformed to OECD test guideline 206, fenarimol was also reported to have low reproductive toxicity to bobwhite quail (Hoffman et al., 1980). In this study, 13% of adults at 0 and 50 ppm died, and this was attributed to trauma caused by aggressive male behaviour; however, there was a further 13% adult mortality at 50 ppm (for a total of 26%) for which the cause was not evident. As there were no deaths at the next highest dose (125 ppm fenarimol), and the eight-day dietary LC50 for this species was reported to be > 6250 ppm, the deaths at 50 ppm were not considered to be treatment-related. A statistically significant reduction in the number of eggs laid was seen at 50 ppm; however, as no such effect was reported at the next highest dose, it is unlikely to be treatment-related. The NOEC was 125 ppm. In a further one-generation study of reproductive toxicity in bobwhite quail, conducted in accordance with EPA 71-4 test guideline and which conformed to OECD test guideline 206, fenarimol was again reported to have little reproductive toxicity to bobwhite quail, with an NOEC of 300 ppm (Hoffman & Cochrane, 1987). No statistically significant or dose-related effect was reported on any of the reproductive parameters measured, including egg production, number of eggs cracked, eggshell thickness, number of eggs set, fertility, embryo survival, hatchability, and hatchling survival. Mammals: No additional data were submitted on the toxicity of fenarimol-containing products to terrestrial vertebrate species other than those reported in Section 7. 5.2 Risk assessment based on agricultural use The information on use and application rates used for this risk assessment is derived from the agricultural use of fenarimol within the European Union. It should be possible to extrapolate the assessment to other agricultural uses at similar application rates elsewhere in the world. 5.2.1 Microorganisms The most significant routes of overexposure of soil micro- organisms to fenarimol are from the high application rates made to turf and the multiple applications made every season in orchards. (a) Turf The maximal rate of application of fenarimol to turf is 6 kg/ha, as four applications of 1.5 kg/ha per year. As reported above, no significant effect on soil respiration or soil microbial populations was seen 98 days after application at a rate equivalent to 168 kg/ha, which is 28 times the maximal recommended field rate. No effect on soil nitrification processes was seen after 15 days at 100 ppm (7 kg a.i./ha) in a growth medium or 28 days at 5 kg/ha in a soil test. These results broadly meet the EPPO (1993) threshold for acceptability of < 25% effect after 100 days, thus indicating that the risk to soil microbial processes from use of fenarimol on turf is low. (b) Orchards The maximal rate of application of fenarimol in orchards is 1.1 kg/ha, from 14 applications of 0.076 kg/ha per year. The data on microbial toxicity presented above indicate that it has no significant effect on soil respiration or microbial processes 98 days after an application equivalent to 168 kg/ha, which is two orders of magnitude higher than the maximal recommended field rate. This result broadly meets the EPPO (1993) threshold for acceptability of < 25% effect after 100 days, thus indicating that the risk to soil microbial processes from use of fenarimol in orchards is low. 5.2.2 Aquatic organisms The first route of high water contamination considered in aquatic risk assessment is overspray, and then the exposure assessment is refined to reflect spray drift. The maximal rates of application within the European Union in categories other than on turf do not differ significantly: 0.12 kg a.i./ha in orchards, 0.06 kg a.i./ha on grapes and hops, and 0.084 kg a.i./ha for other arable and horticul- tural uses; furthermore, multiple applications should not result in an accumulation in surface water, as fenarimol is rapidly removed from the aqueous phase into the sediment phase, with a DT50 of less than seven days in the aqueous phase (see above). The categories orchards, hops and grapes, and other arable and horticultural uses are therefore grouped into a general 'arable and horticultural' category for the purposes of aquatic risk assessment, and 'turf' uses are considered separately, as follows: - application to turf by tractor-mounted and -drawn arable sprayer at 1.5 kg/ha, and - arable and horticultural application by tractor-mounted and -drawn arable sprayer at 0.084 kg/ha and air-assisted sprayer at 0.12 kg/ha. The predicted environmental concentration (PEC) in surface water is:
(a) Acute risk to pelagic organisms The acute LC50 and EC50 values for the most sensitive fish, aquatic invertebrates, and algae reported in section 5.1.2 were 0.8 mg/litre for rainbow trout (Oncorhynchus mykiss), 0.18 mg /litre for Daphnia magna, and 0.76 mg/litre for Raphidocellis subcapitata. These values were used in the 'worst-case' risk assessment for acute exposure of aquatic organisms. Use on turf: Aquatic life may be exposed to fenarimol from its use as the SC formulation on turf after contamination of surface water by direct overspray, spray drift, leaching, or run-off. The 'worst- case' acute surface water PEC for turf use has been calculated as 0.5 mg/litre fenarimol, based on direct overspray contamination of a 3-cm deep static water body at the maximal individual application rate. The TERs for overspray based on the acute PECs and data on toxicity reported in section 5.1.2, were 1.64 for fish, 0.36 for aquatic invertebrates, and 1.52 for algae, indicating a high risk (i.e. lower than the 'acceptable' EPPO (1993) threshold of 10) for all aquatic organisms. Contamination of water by overspray is, however, the worst case, and a more realistic route of contamination is spray drift. On the basis of German BBA data on spray drift -- 5% spray drift at 1 m for arable tractor-mounted and -drawn hydraulic sprayers -- the PEC would be 0.025 mg/litre 1 m from the point of application to turf. If this acute PEC is used, the TERs for spray drift would be revised to 32 for rainbow trout, 7.2 for Daphnia, and 30 for algae, indicating a low acute risk, although the value for Daphnia indicates an acute risk for aquatic invertebrates. Since fenarimol is rapidly removed from the aqueous phase (see section 4), however, the acute risk to fish, aquatic invertebrates, and algae is probably low. Arable and horticultural use: Aquatic life may be exposed to fenarimol in arable and horticultural uses as a result of contam- ination of surface water by direct overspray, spray drift, leaching, or run-off. The 'worst-case' PEC for acute contamination of surface water from this use has been calculated as 0.024 mg/litre for tractor- mounted spray-boom applications and 0.04 mg/litre for air-assisted applications in orchards, based on direct overspray contamination of a 30-cm deep static water body at the maximal individual application rate. For tractor-mounted spray-boom applications, the TERs for overspray based on these acute PEC values and the data on toxicity reported in section 5.1.2 were 34.2 for fish, 7.5 for aquatic invertebrates, and 31.2 for algae. The values for fish and algae are higher than the 'acceptable' EPPO (1993) threshold of 10, indicating that the acute risk should be low. The TER for Daphnia indicates, however, that there may be an acute risk for aquatic invertebrates. Since fenarimol is rapidly removed from the aqueous phase (see section 4), the acute risk to fish, aquatic invertebrates, and algae should be low. For air-assisted spray applications in orchards, the TERs for overspray based on the acute PEC values and the data on toxicity reported in section 5.1.2, were 20.5 for fish, 4.5 for aquatic invertebrates, and 19 for algae. These values are higher than the 'acceptable' EPPO (1993) threshold of 10, indicating that the acute risk to fish and algae should be low; however, the TER for Daphnia indicates that there may be an acute risk for aquatic invertebrates. Since fenarimol is rapidly removed from the aqueous phase (see section 4), the acute risk to fish, aquatic invertebrates, and algae should be low. The TER for spray drift based on 30% deposition at 3 m would increase to 25, indicating a low risk for aquatic invertebrates. (b) Long-term risk for aquatic organisms The long-term NOEC values reported in section 5.1.2 for the most sensitive aquatic species tested were 0.43 mg/litre in a 69-day study of rainbow trout and 0.113 mg/litre in a 21-day study in Daphnia magna. These values were used in the 'worst-case' risk assessment for acute exposure of aquatic organisms. Use on turf: Aquatic life may be exposed to fenarimol for long periods due to its use on turf as a result of initial contamination from overspray or spray drift from up to four successive applications The 'worst-case' PEC for acute contamination of surface water from this use has been calculated on the basis of initial direct contam- ination from overspray of a 30-cm deep, static water body at the maximal individual application rate (see (a) above). As fenarimol is rapidly removed from the aqueous phase of natural sediment-water systems by either photolysis or adsorption onto sediment, with a DT50 in the aqueous phase of less than seven days (see section 4), the long-term PEC for surface water from overspray is unlikely to exceed the acute PEC. With a DT50 of one day, only 0.000003 mg/litre fenarimol of an original 0.5 mg/litre is likely to remain after 14 days. Up to four applications can be made to turf, within a minimal interval of 21-42 days. The mean concentration over 14 days after one application of 1.5 kg/ha of 0.25 mg/litre on turf is used as the 'worst-case' long-term PEC for surface water. The long-term TERs based on this PEC and the data on toxicity reported in section 5.1.2 were 1.72 for rainbow trout and 0.45 for Daphnia magna. These values are lower than the 'acceptable' EPPO (1993) threshold of 10, indicating that there may be a risk to fish and aquatic invertebrates from long-term contamination of water from overspray on turf. Contamination of water by overspray is, however, the worst case, and a more realistic route of contamination is spray drift. On the basis of German BBA data on spray drift-5% spray drift at 1 m for arable tractor-mounted and -drawn hydraulic sprayers -- the PEC would be 0.025 mg/litre for spray drift 1 m from the point of application to turf, which would fall to about 0.0000015 mg/litre after 14 days (for a DT50 of one day), resulting in a mean PEC for exposure to spray drift over 14 days of 0.0125 mg/litre. The TERs would be 34.4 for rainbow trout and 9.04 for Daphnia The TER for fish is higher than the EPPO (1993) threshold of < 10 for unacceptable effects, indicating that the long-term risk for this species of use of fenarimol on turf should be low. Although the TER for Daphnia is 9.04, the fact that fenarimol is rapidly removed from the aqueous phase indicates that the long-term risk for free-swimming aquatic invertebrates should also be low. Arable and horticultural use: Aquatic life may be exposed to fenarimol in arable and horticultural uses as a result of contamination of water by multiple overspraying or spray drift. The 'worst-case' PEC for long-term contamination of surface water from this use has been calculated on the basis of an initial contamination by overspray of a 30-cm deep, static water body at the maximal individual application rates of 0.084 kg/ha for tractor-mounted spray-boom applications and 0.12 kg/ha for air-assisted applications in orchards. In tractor-mounted spray-boom applications, fenarimol is rapidly removed from the aqueous phase of natural sediment-water systems by either photolysis or adsorption onto sediment, resulting in a DT50 in the aqueous phase of less than seven days (see section 4). The long-term PEC in surface water from overspray is therefore unlikely to exceed the acute PEC. With a DT50 of one day, only 0.00019 mg/litre of an original acute PEC of 0.024 mg/litre should remain after seven days. As up to three applications can be made to crops with a minimal interval of 10-14 days, the mean concentration of 0.012 mg/litre over each 10-day period was used as the 'worst-case' long-term PEC in surface water for multiple spray-boom applications of fenarimol in agricultural and horticultural uses. The long-term TERs derived from these PEC values and data on toxicity reported in section 5.1.2 were 35.8 for rainbow trout and 9.4 for Daphnia magna. As the value for rainbow trout is higher than the 'acceptable' EPPO (1993) threshold of 10, the long-term risk to fish is low; however, the value for Daphnia magna is just below the threshold of 10, indicating that this risk should be investigated further. This long-term PEC, based on multiple initial overspraying at the maximal application rate and at the minimal spray interval, is, however, the worst case. The value likely in the field may well be lower, taking into consideration the rapid adsorption of fenarimol onto sediment and its rapid photolysis. It was therefore considered that the TER for Daphnia magna is acceptable and indicates a low long-term risk for free-swimming aquatic invertebrates. In air-assisted spray applications in orchards, fenarimol is rapidly removed from the aqueous phase of natural sediment-water systems by either photolysis or adsorption onto sediment, resulting in a DT50 in the aqueous phase of less than seven days (see section 4). The long-term PEC in surface water from overspray is therefore unlikely to exceed the acute PEC. With a DT50 of one day, only 0.00032 mg/litre of an original acute PEC of 0.04 mg/litre should remain after seven days. As up to four applications can be made to crops with a minimal spray interval of 14 days, the mean concentration of 0.02 mg/litre over each 14-day period was used as the 'worst-case' long-term PEC in surface water for multiple air-assisted spray applications of fenarimol in agricultural and horticultural uses. The chronic TERs based on these PECs and data on toxicity reported in section 5.1.2 were 21.5 for rainbow trout and 5.7 for Daphnia magna. As the value for rainbow trout is higher than the 'acceptable' EPPO (1993) threshold of 10, the long-term risk for fish is low; however, the value for Daphnia magna is below the threshold of 10, indicating that this risk should be investigated further. Contamination of water by overspray is, however, the worst case, and a more realistic route of contamination is spray drift. On the basis of German BBA data on spray drift -- 30% spray drift at 3 m for air-assisted sprayers -- the PEC would be 0.012 mg/litre for spray drift 3 m from the point of application which would fall to 0.00000075 mg/litre after 14 days (for a DT50 of one day), resulting in a mean PEC for exposure to spray drift over 14 days of 0.006 mg/litre. On the basis of this PEC, the TER for Daphnia would be 18.8, which is higher than the EPPO (1993) threshold of < 10 for unacceptable effects, indicating that the chronic risk to pelagic aquatic inverte- brates from air-assisted applications of fenarimol in orchards should be low. (c) Risk to sediment-dwelling invertebrates It is reported in section 4 that 75-80% of fenarimol is partitioned into the sediment phase of natural sediment-water systems within seven days. Therefore, fenarimol entering water due to overspraying, spray drift, leaching, or surface run-off may pose a risk to sediment-dwelling invertebrates. Once fenarimol enters the sediment, there is no appreciable degradation over 80 days, indicating that there may be a long-term risk to sediment-dwelling invertebrates. The PEC in pore water (between sediment particles), calculated by equilibrium partitioning:
Use on turf: The total maximal amount of fenarimol applied to turf in one year is about 6 kg/ha. On the basis of the assumptions of overspraying made in the section on acute risk (overspraying of a 30-cm deep, static water body at the maximal application rate) and assuming that overspraying occurs in all applications, the total amount of fenarimol entering the surrounding water in one year would be 2 mg/litre. Assuming further that all of this amount partitions into a 5-cm layer of sediment (from a 30-cm water column) and a sediment density of 1.5 g/cm3, the total concentration of fenarimol in sediment would be 8 mg/kg. Using equilibrium partitioning, the concentration of fenarimol in the pore water of these sediments, assuming a Koc of 500 (section 4) and an organic carbon content of 2%, would be about 0.8 mg/litre. On the basis of the long-term NOEC for Daphnia magna of 0.113 mg/litre (section 5.1.2) as an indicator of the toxicity of fenarimol to sediment-dwelling invertebrates, the TER would be 0.14, indicating a risk from overspraying on turf. Contamination of water by overspray is, however, the worst case, and a more realistic route of contamination is spray drift. On the basis of 5% drift at 1 m for application to turf (German BBA), the concentrations of fenarimol in sediment pore water would be reduced to about 0.04 mg/litre. On the basis of the long-term NOEC for Daphnia magna of 0.113 mg/litre (section 5.1.2) as an indicator of the toxicity of fenarimol to sediment-dwelling invertebrates, the TER would be 2.8, indicating a long-term risk. The high application rate is, however, essentially a 'spot' treatment on e.g. golf courses, and such highly localized, small-scale applications would result in a low risk for sediment-dwelling invertebrates. Arable and horticultural use: The total maximal amount of fenarimol applied to any one crop in one year is about 0.36 kg/ha (5 × 0.072 kg/ha on ornamental plants) for tractor-mounted spray-boom applications and 1 kg/ha (14 × 0.072 kg/ha in orchards) for air- assisted applications. On the basis of the assumptions of overspraying made in the section on acute risk (overspraying of a 30-cm deep, static water body at the maximal application rate) and assuming that overspraying occurs in all applications, the total amount of fenarimol entering the surrounding water in one year could be 0.12 mg/litre by tractor-mounted spray-boom application and 0.33 mg/litre by air- assisted application. Assuming further that all of this amount partitions into a 5-cm layer of sediment (from a 30-cm water column) and a sediment density of 1.5 g/cm3, the total concentration of fenarimol in sediment would be 0.48 mg/kg with spray-boom application and 1.32 mg/kg with air-assisted application. Using equilibrium partitioning, the concentration of fenarimol in the pore water of these sediment, assuming a Koc of 500 (section 4) and an organic carbon content of 2%, would be about 0.048 mg/litre for spray-boom application and 0.132 mg/litre for air-assisted application. On the basis of the long-term NOEC for Daphnia magna of 0.113 mg/litre (section 5.1.2) as an indicator of the toxicity of fenarimol to sediment-dwelling invertebrates, the TERs would be 2.4 for spray-boom application and 0.86 for air-assisted application. Sediment-dwelling invertebrates may therefore be at risk from overspraying by either route of application. Contamination of water by overspray is, however, the worst case, and a more realistic route of contamination is spray drift. On the basis of 5% drift at 1 m for spray-boom application on arable land and 30% drift at 3 m for air-assisted application in orchards (German BBA), the concentrations of fenarimol in sediment pore water would be reduced to about 0.0024 mg/litre for spray-boom application and 0.04 mg/litre for air-assisted application. On the basis of the long-term NOEC for Daphnia magna of 0.113 mg/litre (section 5.1.2) as an indicator of the toxicity of fenarimol to sediment-dwelling invertebrates, the TERs would be 47 for spray-boom application and 2.8 for air-assisted application, indicating a low risk from spray-boom applications but a long-term risk from air-assisted application. Data on the long-term toxicity of fenarimol to a sediment-dwelling species such as Chironomus would be useful for refining this predicted risk. 5.2.3. Terrestrial organisms (a) Plants No data were available. (b) Invertebrates Bees: Honey bees may be exposed to fenarimol during e.g. application to turf at a maximal rate or orchards with attractive flowering trees. Fenarimol was reported to have low acute toxicity to honey bees, with an oral LD50 of > 10 µg/bee and a contact LD50 of > 100 µg/bee (section 5.1.3). Bees may be exposed to fenarimol while foraging on flowering weeds during or after application. The hazard ratio for use of fenarimol on turf -- application rate (g/ha) divided by the LD50 (µg/bee) -- based on an application rate of 1.5 kg/ha and the data on toxicity reported in section 5.1.3 is < 150 for acute oral exposure and < 15 for acute contact. The hazard ratio for oral exposure is lower than the EPPO (1993) threshold of 50 for 'acceptable' effects, indicating that the acute risk for bees grazing treated turf is low; however, the contact hazard ratio is higher than the EPPO threshold of 50, indicating that there may be a risk. Fenarimol is applied to turf mainly in autumn and winter, however, when bees are unlikely to be foraging. The risk of exposure, and therefore the risk, are thus considered to be low. Bees may also be exposed to fenarimol by foraging the flowers of treated crops or flowering weeds present in the crops. The hazard ratios for such use, based on a maximal application rate of 0.12 kg/ha and the data on toxicity reported in section 5.1.3, are < 12 for acute oral exposure and < 1.2 for acute contact. Both ratios are below the EPPO threshold of 51) for 'acceptable' effects, indicating a low risk for honey bees from these uses of fenarimol. Non-target arthropods: Non-target arthropods may be exposed to fenarimol e.g. from use on turf at the maximal rate or multiple applications on orchards. Small water volumes (200-500 litres/ha) are applied in northern Europe, whereas volumes up to an order of magnitude higher (1500-2000 litres/ha) are used in southern Europe. No data from standard laboratory tests were submitted for non-target arthropod species. A 120-g/litre EC formulation of fenarimol applied at 140 mg/litre was 'harmless' (< 50% effect) to selected non-target arthropods, including the aphid-specific parasi- toid Aphidius matricariae and the predatory mite Typhlodromus pyri (see section 5.1.3). As the EPPO (1993) threshold for further testing is > 30% effect in laboratory tests, it should be ascertained whether the value' < 50% is above that threshold; however, data from semi- field tests showed a < 25% effect on Typhlodromus pyri at a concentration of 140 mg/litre fenarimol. As the concentrations sprayed at a volume of 300 litres/ha ranged from 400 mg/litre in orchards to a maximum of 5000 mg/litre on turf, these data do not fully address the probable effects of fenarimol at relevant concentrations or appli- cation rates, particularly in northern Europe where low-water-volume applications are prevalent. One spraying with a 120 g/litre EC formulation of fenarimol at a concentration of 40 g/litre and an application rate of 60 g/ha in a Belgian orchard had no adverse effect on populations of non-target arthropods (see section 5.1.3); however, the maximal recommended application rate (120 g a.i./ha) was used in a single application, whereas fenarimol can be applied up to 14 times at intervals of 7-14 days. The data indicate that the risk to non-target arthropods should be low, but no results were available from standard laboratory tests with the internationally agreed indicator species Typhlodromus pyri and Aphidius rhopalosiphi (as recommended by Barret et al., 1994) and with the approved maximal application rate and number of applica- tions, particularly in orchards. Such data would be useful for addressing fully the risk for non-target arthropods of exposure to fenarimol. Earthworms: The most significant sources of overexposure of earthworms to fenarimol are due to the high rates of application to turf and the multiple applications made each season in orchards. Fenarimol was moderately toxic to earthworms, with a 14-day LC50 of 200-300 mg/kg of soil for the EC formulation and a 56-day NOEC for reproductive toxicity of 1890 g/ha (see section 5.1.3). The PEC in the top 5 cm of soil after four successive applica- tions of fenarimol at 1.5 kg/ha on turf is 8.57 mg/kg, assuming that the soil density is 1.4 g/cm3, that all of the applied fenarimol enters the soil, and that no degradation occurs between applications (DT50 in laboratory soil, 436-1833 days; section 4). The short-term TER based on this PEC and LD50 values would be 23-35, which is higher than the EPPO (1993) threshold of 10 and indicates a low acute risk for earthworms. When the short-term TER is < 100 and the active substance persists in soil (DT90 > 100 days), EPPO (1993) requires that expert judgement be used to assess whether further data are needed on sublethal toxicity. The TER based on the 14-day NOEC of 100-200 mg/kg of soil would be 12-23, indicating a low risk for sublethal effects. In addition, a study of reproductive toxicity in earthworms with the EC formulation showed a 56-day NOEC of 1890 g/ha, which is greater than the maximal individual application rate to turf and 0.32 times the maximal recommended seasonal application rate; this was the highest dose tested. In a further study, earthworms did not bioaccumulate technical-grade fenarimol over the concentration in the surrounding soil (see section 4). The additional information that degradation of fenarimol is faster in the field than in the laboratory (DT50 in soil in the field, 14-130 days; section 4) indicates that the risk (or sublethal effects in earthworms from the use of fenarimol on turf should be low. The PEC in the top 5 cm of orchard soil after 14 successive applications of fenarimol on apples at 0.072 kg/ha is 1.44 mg/kg of soil, assuming that the soil density is 1.4 g/cm3, that all of the applied fenarimol enters the soil, and that no degradation occurs between applications (DT50 in laboratory soil, 436-1833 days; section 4). The short-term TER based on this PEC and LD50 values would be 139-208, which is higher than the EPPO (1993) threshold of 100 for unacceptable effects and indicates a low acute risk for earthworms from use of fenarimol in orchards. (c) Vertebrates The risk for vertebrates is assessed for four broad categories of use: - in orchards, on apples, pears, peaches, and cherries, at maximal application rates of 0.12 kg/ha of the wettable powder on peaches and 0.06 kg/ha of the EC formulation on cherries; - on hops and grapes, with a maximal application rate of 0.06 kg/ha of the wettable powder on grapes; - on turf, with a maximal application rate of 1.5 kg/ha on amenity and sports turf; and - other horticultural and arable uses, including cane fruit, ornamental plants, and vegetables, with a maximal application rate of 0.084 kg/ha of the EC formulation on strawberries. Birds: LD50 values of > 200 and > 2000 mg/kg bw were reported in two studies of bobwhite quail (see section 5.1.3); however, the first value was derived from a poorly reported study conducted with insufficiently high doses. The value of > 2000 mg/kg bw was therefore used to assess the risk for oral exposure of the most sensitive species tested. The eight-day dietary LC50 of > 6250 ppm fenarimol for mallard duck and bobwhite quail was also used. The examples used were: - a small insectivorous bird, an 11-g blue tit (Parus caeruleus), with a total daily food consumption of 8.25 g, based on 3.3 g dry weight of food per day (Kenaga, 1973); - a fruit-eating bird, an 80-g starling (Sturnus vulgaris), with a total daily food consumption of 60 g, based on 24 g dry weight of food per day (EPPO, 1993); - a grazing bird, a 3-kg greylag goose (Anser anser), with a total daily food consumption of 900 g (Owen, 1975); and - an earthworm-eating bird, an 89-g song thrush (Turdus philomelos), with a total daily food consumption of 22 g, based on 8.8 g dry weight of food per day (Kenaga, 1973). In orchards, birds are exposed from eating either oversprayed insects or treated fruit contaminated with fenarimol residues. The initial residues expected on insects oversprayed at the maximal application rate of 0.12 kg/ha are 3.48 mg/kg of small insects (EPPO, 1993). The short-term dietary TER, based on a dietary eight-day LC50 > 6250 ppm fenarimol, would therefore be > 1796. If the total daily food of a blue tit were contaminated insects, it would take in 0.029 mg of fenarimol, or 2.61 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 766. Both of these TERs are greater than the EPPO (1993) threshold of 100, indicating that the acute risk for insectivorous birds in orchards treated with fenarimol should be low. The initial residues expected on cherries oversprayed at the maximal application rate of 0.06 kg/ha is 0.078 mg/kg of fruit (EPPO, 1993). The short-term dietary TER, based on a dietary eight-day LC50 > 6250 ppm fenarimol, would therefore be > 80 128. If the total daily food of a starling were contaminated cherries, it would take in 0.005 mg of fenarimol, or 0.063 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 31 746. Both of these TERs are greater than the EPPO (1993) threshold of 100; however, residues in cherries before harvesting have been reported to be as high as 0.89 mg/kg of fruit. As this residue is only one order of magnitude higher than the predicted initial residues used to calculate the TERs, those based on residues at harvesting will still be far higher than the threshold value, and the acute risk for fruit-eating birds in orchards treated with fenarimol should be low. In hop gardens and vineyards, birds are exposed from eating either oversprayed insects or treated fruit contaminated with fenarimol residues. The initial residues expected on insects oversprayed at the maximal application rate of 0.06 kg/ha is 1.74 mg/kg of small insects (EPPO, 1993). The short-term dietary TER, based on a dietary eight-day LC50 > 6250 ppm fenarimol, would therefore be > 3592. If the total daily food of a blue tit were contaminated insects, it would take in 0.014 mg of fenarimol, or 1.31 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 1527. Both of these TERs are greater than the EPPO (1993) threshold of 100, indicating that the acute risk for insectivorous birds in hop gardens and vineyards treated with fenarimol should be low. The initial residues expected on grapes oversprayed at the maximal application rate of 0.06 kg/ha is 0.078 mg/kg of fruit (EPPO, 1993). The short-term dietary TER, based on a dietary eight-day LC50 > 6250 ppm fenarimol, would therefore be > 80 128. If the total daily food of a starling were contaminated grapes, it would take in 0.005 mg of fenarimol, or 0.063 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 31 746. Both of these TERs are greater than the EPPO (1993) threshold of 100. Residues in grapes before harvesting have been reported to be as high as 0.04 mg/kg, which is lower than the predicted initial residues used to calculate the TERs and indicates that the risk for birds eating grapes around harvest time is less than that for birds eating grapes immediately after application. The values indicate that the acute risk to fruit-eating birds in vineyards and hop gardens treated with fenarimol should be low. When fenarimol is applied to turf, birds are likely to be exposed either by grazing treated grass or eating earthworms contaminated with fenarimol residues. The initial residue expected on short grass oversprayed at 1.5 kg/ha is 168 mg/kg of grass (EPPO, 1993). The short-term dietary TER, based on a dietary eight-day LC50 of > 6250 ppm fenarimol, would therefore be > 37.2. If the total daily food of a greylag goose were contaminated grass, it would take in 151 mg of fenarimol, or 50.3 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 39.7. Both of these TERs are lower than the EPPO (1993) threshold of 100, which requires that the risk be assessed further. As application is done mainly in autumn and winter, the initial residues are unlikely to remain for long before being washed off or diluted by rainfall. In addition, the values for toxicity used in the risk assessment are 'greater than' values, and the actual TERs may well be significantly higher than those currently reported. Furthermore, although the United Kingdom has the highest application rate to turf within the European Union, no incidents of bird poisoning involving fenarimol have been reported in the UK Wildlife Incident Investigation Scheme. The risk to grazing birds from the use of fenarimol on turf would therefore appear to be low. The expected residue of fenarimol in soil after application of 6 kg/ha, in four applications of 1.5 kg/ha per year with no signi- ficant degradation in soil (DT50 in field soil, 14-130 days; see section 5.1.3), is 8.58 mg/kg of soil, assuming a soil depth of 5 cm and bulk density of 1.4 g/cm3. As at an application rate equivalent to 7 kg/ha (10 mg/kg of soil) earthworms did not accumulate residues at concentrations greater than those in the surrounding soil, the maximal concentration of fenarimol in the earthworms would be 8.58 mg/kg. The short-term dietary TER, based on a dietary eight-day LC50 of > 6250 ppm fenarimol, would therefore be > 728. If the total daily food of a song thrush were contaminated earthworms, it would take in 0.19 mg of fenarimol, or 2.12 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 943. Both of these TERs are greater than the EPPO (1993) threshold of 100, indicating that the acute risk for earthworm-eating birds on turf treated with fenarimol should be low. In other agricultural and horticultural uses of fenarimol, birds are likely to be exposed by consuming either oversprayed insects or treated produce (e.g. strawberries) contaminated with fenarimol residues. The initial residues expected on insects oversprayed at 0.084 kg/ha is 2.44 mg/kg of small insects (EPPO, 1993). The short- term dietary TER, based on a dietary eight-day LC50 > 6250 ppm fenarimol, would therefore be > 2561. If the total daily food of a blue tit were contaminated insects, it would take in 0.02 mg of fenarimol, or 1.83 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 1093. Both of these TERs are greater than the EPPO (1993) threshold of 100, indicating that the acute risk for insectivorous birds in other arable and horticultural uses of fenarimol should be low. The initial residues expected on strawberries oversprayed at 0.084 kg/ha is 0.12 mg/kg of fruit (EPPO, 1993). The short-term dietary TER, based on a dietary eight-day LC50 > 6250 ppm fenarimol, would therefore be > 52 083. If the total daily food of a starling were contaminated insects, it would take in 0.007 mg of fenarimol, or 0.09 mg/kg bw. The acute oral TER based on the acute oral LD50 of > 2000 mg/kg bw would therefore be > 22 222. Both of these TERs are greater than the EPPO (1993) threshold of 100; however, residues in strawberries before harvesting have been reported to be as high as 0.14 mg/kg of fruit. As this residue is within one order of magnitude of the predicted initial residues used to calculate the TERs, those based on residues at harvesting will still be far higher than the threshold value, and the acute risk for these birds from the use of fenarimol should be low. NOEC values of 125 and 300 ppm fenarimol have been reported for reproductive toxicity in bobwhite quail in two studies (see section 5.1.3); an NOEC of 250 ppm was reported tor mallard ducks but was revised to 50 ppm. The last value was used in the risk assessment for the most sensitive species tested. The main risk for reproducing birds is during multiple applications throughout a season. The 'worst case' of > 14 applications of a wettable powder tormulation of fenarimol on apples and pears in orchards at 0.076 kg/ha in any one season was investigated. In orchards, breeding birds are likely to be exposed by eating oversprayed insects or treated fruit (e.g. cherries) contaminated with fenarimol residues. The expected initial residue on small :insects oversprayed with fenarimol at 0.076 kg/ha is 2.2 mg/kg (EPPO, 1993). The TER for reproductive toxicity, based on the NOEC of 50 ppm, would therefore be 22.7. This value is greater than the EPPO (1993) threshold of 10, indicating a low risk to insectivorous birds in orchards treated with fenarimol. The expected initial residues on cherries oversprayed with fenarimol at 0.06 kg/ha is 0.078 mg/kg of fruit (EPPO, 1993). The TER for reproductive toxicity, based on the NOEC of 50 ppm, would therefore be 642; however, residues in cherries before harvesting have been reported to be as high as 0.89 mg/kg. Use of this residue value would reduce the TER to 56. Both of these values are greater than the EPPO (1993) threshold of 10, indicating that the risk for reproductive toxicity to fruit-eating birds in orchards treated with fenarimol should be low. Mammals: An oral LD50 for fenarimol of 2500 mg/kg bw was reported in rats, the most sensitive species tested, and this value was used in the risk assessment. The examples used were: - a small earthworm-eating mammal, an 18-g common shrew (Sorex araneus), with a total daily food consumption of 18 g (Churchfield, 1986); - a small fruit-eating mammal, an 18-g wood mouse (Apodemus sylvaticus), with a total daily food consumption of 7.5 g food/day, based on 3 g dry weight of food per day (Corbet & Harris, 1991); and - a grazing mammal, a 1200-g rabbit (Oryctolagus cuniculus), with a total daily food consumption of 500 g (Ross, personal communication). In orchards, mammals are likely to be exposed only by eating earthworms contaminated with fenarimol residues. The expected residues in soil treated with fenarimol at 1.1 kg/ha in 14 applications of 0.076 kg/ha and with no significant degradation in soil (DT50 in field soil, 14-130 days) is 1.57 mg/kg of soil, assuming a soil depth of 5 cm and bulk density of 1.4 g/cm3. At application rates equivalent to 7 kg/ha (10 mg/kg of soil), earthworms did not accumulate residues at levels greater than the concentration of fenarimol in the surrounding soil, so that the maximal concentration in the earthworms would be 1.57 mg/kg. If the total daily food consumption of a common shrew were contaminated earthworms, it would consume 0.03 mg of fenarimol, or 1.57 mg/kg bw. The acute oral TER, based on an acute oral LD50 of 2500 mg/kg bw, would therefore be 1592, which is greater than the EPPO (1993) threshold of 100, indicating that the acute risk to earthworm-eating mammals of use of fenarimol in orchards should be low. In hop gardens and vineyards, mammals are thought to be exposed by eating oversprayed insects or treated fruit (e.g. grapes) contam- inated with fenarimol residues. The initial residues expected on insects oversprayed at the maximal application rate of 0.06 kg/ha is 1.74 mg/kg of small insects (EPPO, 1993). If the total daily food of a common shrew were contaminated insects, it would take in 0.03 mg of fenarimol, or 1.74 mg/kg bw. The acute oral TER based on the acute oral LD50 of 2500 mg/kg bw would therefore be 1437. This value is greater than the EPPO (1993) threshold of 100, indicating that the acute risk for insectivorous mammals in hop gardens and vineyards treated with fenarimol should be low. The initial residues expected on grapes oversprayed at 0.06 kg/ha is 0.078 mg/kg of fruit (EPPO, 1993). If the total daily food of a wood mouse were contaminated grapes, it would take in 0.006 mg of fenarimol, or 10.33 mg/kg bw. The acute oral TER based on the acute oral LD50 of 2500 mg/kg bw would therefore be 7500. This value is greater than the EPPO (1993) threshold of 100. Residues in grapes before harvesting have been reported to be as high as 0.04 mg/kg of fruit, a value below the predicted initial residues used to calculate the TER, indicating that the risk to mammals eating grapes around harvest time is less than that for mammals eating grapes immediately after application. The TER therefore indicates that the acute risk for fruit-eating mammals in vineyards and hop gardens from the use of fenarimol should be low. When fenarimol is used to treat turf, mammals are exposed by grazing treated grass or eating earthworms contaminated with fenarimol residues. The initial residues expected on short grass oversprayed at 1.5 kg/ha is 168 mg/kg of grass (EPPO, 1993). If the total daily food of a rabbit were contaminated grass, it would take in 84 mg of fenarimol, or 70 mg/kg bw. The acute oral TER based on the acute oral LD50 of 2500 mg/kg bw would therefore be 35.7. This value is lower than the EPPO (1993) threshold of 100, which requires that the risk be assessed further. As application is done mainly in autumn and winter, the initial residues are unlikely to remain for long before being washed off or diluted by rainfall. The actual TER may therefore well be significantly higher than those currently reported. Furthermore, although the United Kingdom has the highest application rate to turf within the European Union, no incidents of mammalian poisoning involving fenarimol have been reported in the UK Wildlife Incident Investigation Scheme. The risk to grazing mammals from the use of fenarimol on turf would therefore appear to be low. The expected residue of fenarimol in soil after application of 6 kg/ha, in four applications of 1.5 kg/ha per year with no signi- ficant degradation in soil (DT50 in field soil, 14-130 days; see section 5.1.3), is 8.57 mg/kg of soil, assuming a soil depth of 5 cm and bulk density of 1.4 g/cm3. As at an application rate equivalent to 7 kg/ha (10 mg/kg of soil) earthworms did not accumulate residues at concentrations greater than those in the surrounding soil, the maximal concentration of fenarimol in the earthworms would be 8.57 mg/kg. If the total daily food of a common shrew were contaminated earthworms, it would take in 0.15 mg of fenarimol, or 8.57 mg/kg bw. The acute oral TER based on the acute oral LD50 of 2500 mg/kg bw would therefore be 291. This value is greater than the EPPO (1993) threshold of 100, indicating that the acute risk for earthworm-eating mammals on turf treated with fenarimol should be low. In other agricultural and horticultural uses of fenarimol, mammals are likely to be exposed by consuming either oversprayed insects or treated produce (e.g. strawberries) contaminated with fenarimol residues. The initial residues expected on insects oversprayed at 0.084 kg/ha is 2.44 mg/kg of small insects (EPPO, 1993). If the total daily food of a common shrew were contaminated insects, it would take in 0.04 mg of fenarimol, or 2.44 mg/kg bw. The acute oral TER based on the acute oral LD50 of 2500 mg/kg bw would therefore be 1025. This value is greater than the EPPO (1993) threshold of 100, indicating that the acute risk for insectivorous mammals in other arable and horticultural uses of fenarimol should be low. The initial residues expected on strawberries oversprayed at 0.084 kg/ha is 0.12 mg/kg of fruit (EPPO, 1993). If the total daily food of a wood mouse were contaminated insects, it would take in 0.001 mg of fenarimol, or 0.05 mg/kg bw. The acute oral TER based on the acute oral LD50 of 2500 mg/kg bw would therefore be 50 000. This value is greater than the EPPO (1993) threshold of 100; however, residues in strawberries before harvesting have been reported to be as high as 0.14 mg/kg of fruit. As this residue is within one order of magnitude of the predicted initial residues used to calculate the TERs, those based on residues at harvesting will still be far higher than the threshold value, and the acute risk for these birds from the use of fenarimol should be low. 6. Evaluation of effects on the environment Fenarimol is a systemic fungicide used on a wide range of fruit, vegetables, hops, and wheat. It is registered in a large number of countries. It is rapidly adsorbed onto soil and sediments; in a series of laboratory experiments it showed no tendency to leach and stayed in the top few centimetres of soil. A persistence of several months in soil was confirmed in the field. Photolysis has been shown to occur, but because of factors including the type of use and its ready adsorption on soil and sediments photolysis is not considered to be a significant mechanism for degradation. Fenarimol was not biodegradable in studies in the field or the laboratory under either aerobic or anaerobic conditions. Hydrolysis has been shown to occur only at extreme pH. The compound is therefore highly persistent and not mobile. It bioaccumulates to a very limited degree, and depuration of contaminated tissues takes place within a few days in both aquatic and terrestrial organisms (fish and earthworms). It had no effect on soil respiration or nitrification processes at concentrations much higher than the normal application rates; similar results were obtained in sewage sludges. The LC50 and EC50 values for fenarimol were 0.82 mg/litre for the most sensitive fish, 0.1.8 mg/litre for the most sensitive aquatic invertebrate, and 0.76 mg/litre for the most sensitive alga. In long-term experiments, the NOEC values were 0.43 mg/litre for fish and 0.113 mg/litre for aquatic invertebrates. Fenarimol had low acute toxicity for honey bees, with an acute oral LD50 of > 10 and a contact LD50 of >100 mg per bee. Little toxicity was seen in earthworms, with an acute LC50 of 200-300 mg/kg and an NOEC for reproductive effects of 1.89 kg/ha. It was also of little toxicity to birds, with an acute oral LD50 of > 2000 mg/kg bw and an NOEL of 2000 mg/kg bw; however, reduced body weight was observed, with an NOEC of 250 mg/kg of food. Several studies of reproductive toxicity gave NOEC values of 50-300 mg/kg of food for different birds. No data were available on the toxicity of fenarimol to wild mammals, but the LD50 for laboratory mammals was 2500 mg/kg bw. Risk assessment At application rates equivalent to 28 times the maximal recommended rate for fenarimol (4 × 1.5 kg/ha on turf), there was no significant effect on soil respiration or microbial processes. The risk to aquatic organisms was assessed on the basis of the 'worst- case' examples of contamination by spray drift or overspray during tractor-mounted spray-boom application to turf at 4 × 1.5 kg/ha and air-assisted spray application to orchards at 14 × 0.072 kg/ha (Tables 4 and 5). Details of the method for calculating the PEC are given in the monograph on fenthion. The summaries of acute and long-term TERs for aquatic organisms reported above indicate that fenarimol presents a small risk to aquatic life, except in multiple applications in orchards, which present a medium-high risk to sediment-dwelling invertebrates. Table 4. Acute risk to aquatic organisms from spray drift or overspray contamination arising from use of fenarimol by boom- or air-assisted spray Organism LC50/EC50 Application Acute PECa Acute TER Risk (mg/litre) (mg/litre) Fish 0.8 Tractor boom spray 0.025b 32 Low Fish 0.8 Air-assisted spray 0.04c 20 Low Aquatic invertebrates 0.18 Tractor boom spray 0.025b 7.2 Presentd Aquatic invertebrates 0.18 Air-assisted spray 0.04b 25 Low Algae 0.76 Tractor boom spray 0.025b 30 Low Algae 0.76 Air-assisted spray 0.04c 19 Low PEC, predicted environmental concentration; TER, toxicity:exposure ratio a Based on one application b Spray drift c Overspray d The risk is considered to be low owing to the small-scale, localized nature of turf applications. The risk for bees was considered to be low, since the hazard ratios reported for the highest recommended application rates (1.5 kg/ha) were < 150 for acute oral exposure and < 15 for acute contact exposure. The recommended timing of application is when bees are unlikely to be foraging. The limited data on non-target arthropods do not allow a full assessment of the risk. On the basis of the high rate of application to turf (1.5 kg/ha) and the multiple applications in orchards (14 × 0.072 kg/ha), the 'worst-case' short-term TER for earthworms was 23-35 and the long-term TER was 139-208, indicating a low risk. The risks to insectivorous, grazing, and fruit-eating birds and mammals in the 'worst-case' situations of high application rates to turf (1.5 kg/ha) and multiple applications in orchards (0.072 kg/ha) or on strawberries (0.084 kg/ha) are shown in Tables 6 and 7. The TERs shown in these tables indicate a low risk (i.e. > 100), except for grazing birds and mammals, after heavy use of fenarimol on turf. No poisoning incidents have been associated in wildlife monitoring in the United Kingdom with such use, suggesting that the actual risk is low. At the same levels of exposure, the TERs for reproductive toxicity were 22.7 for insectivorous birds and 56 for fruit-eating birds, indicating a low risk to reproducing birds. Table 5. Long-term risk to aquatic organisms from spray drift or overspray contamination arising from multiple applications of fenarimol by boom- or air-assisted spray Organism NOEC Application PECa TER Risk (mg/litre) (mg/litre) Fish 0.43 Tractor boom spray 0.0125b 34 Low Fish 0.43 Air-assisted spray 0.02c 21 Low Aquatic invertebrates 0.113 Tractor boom spray 0.0125b 9 Presentd Aquatic invertebrates 0.113 Air-assisted spray 0.006b 18.8 Low Sediment invertebrates 0.113e Tractor boom spray 0.04b 2.8 Presentd Sediment invertebrates 0.113e Air-assisted spray 0.04c 2.8 Present PEC, predicted environmental concentration; TER, toxicity:exposure ratio a Based on maximal recommended application b Spray drift c Overspray d The risk is considered to be low owing to the small-scale, localized nature of turf applications. e Based on long-term toxicity to Daphnia Table 6. Risks to insectivorous, grazing, and fruit-eating birds from the use of fenarimol on turf and in orchards Organism Use Food type Food residue LC50 TER Risk (mg/kg food) (mg/kg food) Grelag goose (Anser anser) Turf Vegetation 168a > 6250 > 37.2 Low Song thrush (Turdus philomelos) Turf Earthworms 8.58b > 6250 > 728 Negligible Starling (Sturnus vulgaris) Orchard Cherries 0.89b > 6250 > 7022 Negligible TER, toxicity:exposure ratio a Calculated from the vertebrate risk assessment scheme of the European Plant Protection Organisation/Council of Europe b Based on actual data on residue levels 7. Further research Studies are required on the long-term toxicity of fenarimol- contaminated sediment to sediment-dwelling invertebrates. Table 7. Risks to insectivorous, grazing, and fruit-eating mammals from the use of fenarimol on turf and soft fruit Organism Use Food type Food residue Expected daily LD50 TER Risk (mg/kg food) intake (mg/kg bw) Shrew (Sorex araneus) Turf Earthworms 8.58a 8.57 2500 291 Negligible Rabbit (Oryctolagus cuniculus) Turf Grass 168b 70 2500 35.7 Low Wood mouse (Apodemus sylvaticus) Soft fruit Strawberries 0.14b 0.06 2500 > 10 000 Negligible TER, toxicity:exposure ratio a Based on actual data on residue levels b Calculated 8. Previous evaluations by international bodies A monograph on fenarimol is available from the European Commission (91/414/EEC). References Althaus, W.A. (1983) Fenarimol bluegill bioconcentration study. DowElanco Company report. Althaus, W.A. (1984) A comparative photodegradation study conducted with carbinol-labelled, o-chlorophenyl-labelled, p-chlorophenyl- labelled, and mixed-labelled 14C fenarimol. DowElanco Company report. Althaus, W.A. & Beaty, J.A. 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See Also: Toxicological Abbreviations Fenarimol (Pesticide residues in food: 1995 evaluations Part II Toxicological & Environmental)