VOL.: 73 (1999) (p. 49)
CAS No.:Exposure to ortho-anisidine may occur during its production and its use as a chemical intermediate, a corrosion inhibitor and an industrial antioxidant.
5.2 Human carcinogenicity data
No data were available to the Working Group.
5.3 Animal carcinogenicity data
ortho-Anisidine hydrochloride was tested for carcinogenicity in one study in mice and one study in rats by oral administration in the diet. It produced transitional-cell carcinomas of the urinary bladder in animals of each species and sex.
5.4 Other relevant data
Limited information was available to the Working Group on the metabolism of ortho-anisidine. It was shown to be O-dealkylated in rat liver microsomes.
ortho-Anisidine at a high dose increased the incidence of hyperplasia of the bladder in male and female mice.
No data were available on the developmental and reproductive effects of ortho-anisidine.
No data were available on the genetic and related effects of ortho-anisidine in humans. No conclusion can be drawn about its genotoxicity in experimental animals in vivo; however, ortho-anisidine induced gene mutation in bladder cells in an assay in transgenic mice. There is no evidence that it has genotoxic effects in mammalian cells in vitro. ortho-Anisidine was not mutagenic to bacteria.
5.5 Evaluation
There is inadequate evidence in humans for the carcinogenicity of ortho-anisidine.
There is sufficient evidence in experimental animals for the carcinogenicity of ortho-anisidine.
Overall evaluation
ortho-Anisidine is possibly carcinogenic to humans (Group 2B).
For definition of the italicized terms, see Preamble Evaluation.
Previous evaluations: Vol. 27 (1982); Suppl. 7 (1987) (p. 57)
Synonyms
See Also: Toxicological Abbreviations