Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is fom peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Dominant lethal mutagenicity study on hair dyes
Author:
C. Burnett, R. Loehr & J. Corbett
Year:
1977
Bibliographic source:
Journal of Toxicology and Environmental Health, 2:3, 657-66, 1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
The test material was tested for percutaneous toxicity in groups of four to eight New Zealand rabbits (1.7-2.5 kg). The rabbits were shaved closely the day before the materials were applied in 10 ml of an oxidation-type hair dye base. The period of application was 24 hr.
GLP compliance:
not specified
Test type:
other: no data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):2 nitro p phenylene diamine - Substance type:Organic- Physical state:Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALSSource: No dataAge at study initiation: No dataWeight at study initiation: 1.7-2.5 kg Fasting period before study: No data Housing: No dataDiet (e.g. ad libitum): No dataWater (e.g. ad libitum): No dataAcclimation period: No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
The rabbits were shaved closely the day before the materials were applied in 10 ml of an oxidation-type hair dye base
Duration of exposure:
24 hrs
Doses:
5000 mg/kg (as 10 ml)
No. of animals per sex per dose:
4-8
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The test material was tested for percutaneous toxicity in groups of four to eight New Zealand rabbits (1.7-2.5 kg). The rabbits were shaved closely the day before the materials were applied in 10 ml of an oxidation-type hair dye base. The period of application was 24 hr.The LD50 for the test material in rabbits is > 5000mg/kg
Executive summary:

The test material was tested for percutaneous toxicity in groups of four to eight New Zealand rabbits (1.7-2.5 kg). The rabbits were shaved closely the day before the materials were applied in 10 ml of an oxidation-type hair dye base. The period of application was 24 hr.

 

The LD50 for the test material in rabbits is > 5000mg/kg