Registration Dossier

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.