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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: oral
Adequacy of study:
other information
Reliability:
other: Not applicable since exclusively summarizing data coming from an existing risk assessment (BUA Report) are presented as executive summary.

Data source

Reference
Reference Type:
other: Risk assessment
Title:
Phenylenediamines, BUA Report 97
Author:
GDCh-Advisory Committee on Existing Chemicals of Environmental Relevance (BUA)
Year:
1992
Bibliographic source:
edited by the GDCh-Advisory Committee on Existing Chemicals of Environmental Relevance, S. Hirzel, Wissenschaftliche Verlagsgesellschaft, Birkenwaldstraße 44, 70191 Stuttgart, 1995

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The orally tolerated dose (NOEL) in subchronic studies in the rat was between less than 33.5 and 75 mg/kg for p-phenylenediamine.
Executive summary:

Available studies reveal no evidence of substance-typical toxicity in rodents. Repeated administration of p-phenylenediamine to experimental animals at an oral dose of 33.5 mg/kg body weight/day caused degenerative changes in the liver. The orally tolerated dose (NOEL) in subchronic studies in the rat was between less than 33.5 ( 12 or 80 weeks) and 75 mg/kg (7 weeks) for p-phenylenediamine. The mouse tolerated 150 mg/kg bw without symptoms after oral administration for 7 weeks.