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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from 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.Volume 2, 1977 - Issue 3, 657-662.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The toxicity study was examined to evaluate the acute toxic effects of administration of m-phenylenediamine (CAS No. 108-45-2) in rabbits by the dermal route.
GLP compliance:
not specified
Test type:
other: No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):m-phenylenediamine
- Substance type:organic

Test animals

Species:
rabbit
Strain:
other: New Zealand rabbits
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation:1.7-2.5 kg

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
four to eight rabbits.
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.
Remarks on result:
other: this test substance is "practically non-toxic"by a single skin application.
Mortality:
m-phenylenediamine caused deaths at a dose of 5 g/kg body weight.
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The acute dermal median lethal dose (LD50) of m-phenylenediamine (CAS No.- 108-45-2) in rabbit was observed to be 5000.0 mg/kg b.wt.
Executive summary:

The toxicity study was examined to evaluate the acute toxic effects of administration of m-phenylenediamine (CAS No. 108-45-2) in rabbits by the dermal route. The acute dermal median lethal dose (LD50) of m-phenylenediamine in rabbit was observed to be 5000.0 mg/kg b.wt. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that m-phenylenediamine (CAS No.- 108-45-2) does not classify as an acute dermal toxicant.