Registration Dossier
Registration Dossier
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EC number: 201-963-1 | CAS number: 90-04-0
Toxicity to reproduction
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:
- 1 978
- Reference Type:
- review article or handbook
- Title:
- European Union Risk Assessment Report - o-Anisidin
- Author:
- European Chemicals Bureau
- Year:
- 2 002
- 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
- Reference substance name:
- 134-29-2
- EC Number:
- 603-807-1
- Cas Number:
- 134-29-2
- IUPAC Name:
- 134-29-2
- Reference substance name:
- 2-methoxyaniline hydrochloride
- IUPAC Name:
- 2-methoxyaniline hydrochloride
Constituent 1
Constituent 2
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.
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