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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

Constituent 1
Reference substance name:
m-phenylenediamine
IUPAC Name:
m-phenylenediamine
Constituent 2
Reference substance name:
m-phenylenediamine
EC Number:
203-584-7
EC Name:
m-phenylenediamine
IUPAC Name:
203-584-7
Constituent 3
Reference substance name:
108-45-2
Cas Number:
108-45-2
IUPAC Name:
108-45-2
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 or test system 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:
other: 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.