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Administrative data

Endpoint:
toxicity to reproduction
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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary source available
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Reference Type:
review article or handbook
Title:
European Union Risk Assessment Report - o-Anisidin
Author:
European Chemicals Bureau
Year:
2002
Bibliographic source:
European Commission, Joint Research Center, EUR 19834 EN, 2nd Priority list, Volume 15

Materials and methods

Principles of method if other than guideline:
observations of histopathological examinations in a carcinogenicity study

Test material

Constituent 1
Reference substance name:
134-29-2
EC Number:
603-807-1
Cas Number:
134-29-2
IUPAC Name:
134-29-2
Constituent 2
Reference substance name:
2-methoxyaniline hydrochloride
IUPAC Name:
2-methoxyaniline hydrochloride

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

There are no studies available on reproductive toxicity for o-anisidine.

Observations of histopathological examinations of the NCI (1978) two year carcinogenicity study (test item: o-anisidine hydrochloride) with mice and rats showed no effects on the male and female reproductive organs (examinations included: seminal vesicles, prostate, and testis in males; ovary and uterus in females).

In a 28 day repeated dose toxicity study (test item: o-anisidine, oral application) with male and female rats no effects on the testis were seen (female organs were not examined) (see section 7.5.1).

Applicant's summary and conclusion

Conclusions:
In the RAR the authors concluded that due to the fact that no microscopic effects on reproductive organs were observed in a 2-year carcinogenicity study as well as in a subacute repeated dose study o-anisidine does not impair reproduction.