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Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
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

Data source

Reference
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

Test material

Constituent 1
Reference substance name:
2-aminophenol
EC Number:
202-431-1
EC Name:
2-aminophenol
Cas Number:
95-55-6
IUPAC Name:
2-aminophenol
Constituent 2
Reference substance name:
4-aminophenol
EC Number:
204-616-2
EC Name:
4-aminophenol
Cas Number:
123-30-8
IUPAC Name:
4-aminophenol
Constituent 3
Chemical structure
Reference substance name:
Aniline
EC Number:
200-539-3
EC Name:
Aniline
Cas Number:
62-53-3
Molecular formula:
C6H7N
IUPAC Name:
aniline

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

In the RAR there are data dealing with developmental toxicity and teratogenic effects of different structurally related substances to o-anisidine.

O-aminophenol, a known metabolite of o-anisidine, revealed embryotoxic and teratogenic properties investigated in the syrian hamster (i.p.application of 100 mg/kg bw; no maternal toxicity was observed at this dose).

P-aminophenol, a structurally less related substance, showed clearly teratogenic and developmental toxic effects. For example in several studies after oral application in rats (no statements given whether there was maternal toxicity observed) as well as in hamster after i.p. or i.v. application in the absence of toxicity to the dams.

For aniline there was also evidence for developmental toxicity and teratogenicity.

Applicant's summary and conclusion

Conclusions:
The authors of the RAR concluded that due to lack of data no statement concerning developmental toxicity/teratogenicity of o-anisidine can be given, but due to positive evidence from related substances, "o-anisidine may be suspected to possess teratogenic properties."