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Repeated dose toxicity: oral

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repeated dose toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
year of publication: 2002
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary source available
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Reference Type:
review article or handbook
European Union Risk Assessment Report - o-Anisidin
European Chemicals Bureau
Bibliographic source:
European Commission, Joint Research Center, EUR 19834 EN, 2nd Priority list, Volume 15

Materials and methods

Test material

Constituent 1
Reference substance name:
EC Number:
Cas Number:
Constituent 2
Reference substance name:
2-methoxyaniline hydrochloride
2-methoxyaniline hydrochloride

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

F344 rats and B6C3F1 mice were subjected to an oral range finding study for o-anisidine hydrochloride (CAS no. 123 -29 -2). The conditions used were as follows: application of 0 - 1,000 - 3,000 -10,000 or 30,000 ppm o-anisidine hydrochloride for 7 weeks via diet to 5 animals/sex/dose (applied doses corresponding to the following body doses in rats: ca. 75, 225,750 or 2,250 mg/kg bw and day; and in mice: ca. 150, 450, 1,500 or 4,500 mg/kg bw and day).

The results are summarized in the RAR in such a way: doses, which are greater or equal "10,000 ppm in rats resulted in dose-dependent weight depression of more than 10% and moderately enlarged spleens, which were black and granular; spleens of male rats administered 1,000 or 3,000 ppm were granular. In mice doses of (> or equal) 3,000 ppm resulted in dose-dependent weight depression of more than 10%; at doses of (> or equal) 10,000 ppm the spleens were also black and enlarged (NCI, 1978)."

Furthermore, the effects seen in the main 2 year-study performed by the NCI (1978) are described too. F344 rats fed with doses of 0, 5000 or 10000 ppm of o-anisidine hydrochloride were killed at 103 -107 weeks and for all animals (the ones found dead as well as the ones sacrificed in the end) histopathological examinations were performed. There was a dose-related depression of body weight noted, but all the non-neoplastic lesions found in histopathology were considered to be not compund related.

In mice the applied doses were 0, 2500 or 5000 ppm and the surviving animals were killed at weeks 104 or 105 of the bioassay. Effects observed are the same as for rats (see above).

Applicant's summary and conclusion

According to the RAR the oral range finding as well as the 2 -year study in mice and rats conducted by the NCI revealed dose-related depression of body weights for both species, as well as effects on the spleen of the animals could be observed (moderately enlarged spleens, which were black and granular).
The test substance o-anisidin hydrochloride is thought to be suitable to describe the effects which would also be induced by o-anisidine itself.