Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only abstract available

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
4-Aminoazobenzene
Author:
Beratergremium für Altstoffe (BUA)
Year:
1998
Bibliographic source:
BUA-Stoffbericht 217. BUA der Gesellschaft dt. Chemiker, S. Hirzel Wissenschaftliche Verlagsgesellschaft, Stuttgart.
Reference Type:
study report
Title:
Unnamed
Year:
1992
Reference Type:
secondary source
Title:
IUCLID
Author:
ECB
Year:
2007
Bibliographic source:
ECB IUCLID Dataset
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EEC p. 103
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4- Aminoazobenzene
- Analytical purity: 98.6%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Cremophor EL
Details on dermal exposure:
no data
Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 female and 5 male
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
slight cyanosis in 1 male and 2 female rats (both day 3);
ruffled fur in 1 male;
yellow skin in all animals (day 5-13)
Body weight:
no data
Gross pathology:
no pathological alterations

Applicant's summary and conclusion