Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary source available. No data on test protocol.

Data source

Reference
Reference Type:
secondary source
Title:
Toxicological Evaluations 12 - Potential Health Hazards of Existing Chemicals.
Author:
BG Chemie
Bibliographic source:
Toxicological Evaluations, volume 12, section "N,N'-di-sec-butyl-p-phenylenediamine", p. 193-203. Published by Springer.

Materials and methods

Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technical grade

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on exposure:
clipped dorsal skin
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 weeks
Frequency of treatment:
5 days / week
Doses / concentrations
Remarks:
Doses / Concentrations:
90 mg / kg bw
Basis:
nominal per unit body weight
No. of animals per sex per dose:
3 male rats
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
irritant effects and ulceration of the skin
Mortality:
no mortality observed
Details on results:
No changes in haematological parameters other than granulocytosis were observed in the treated rats compared with 3 control rats.
The methaemoglobin level was not increased.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion