2-methyl-p-phenylenediamine sulfate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test material was applied on shaved skin of rabbit for the determination of percutaneous toxicity.
Insufficient data provided to determine if a specific guideline was followed.

GLP compliance:

no

Remarks:

pre GLP

Test type:

other: no data

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-p-phenylenediamine sulfate

EC Number:

210-431-8

EC Name:

2-methyl-p-phenylenediamine sulfate

Cas Number:

615-50-9

Molecular formula:

C7H10N2.H2O4S

IUPAC Name:

2-methylbenzene-1,4-diamine; sulfuric acid

Constituent 2

Reference substance name:

2-methyl-p-phenylenediamine sulphate

EC Number:

228-871-4

EC Name:

2-methyl-p-phenylenediamine sulphate

Cas Number:

6369-59-1

IUPAC Name:

2-methylbenzene-1,4-diamine sulfate

Details on test material:

- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Name of test material: p-toluenediamine sulfate
- Molecular formula (if other than submission substance): Not reported
- Molecular weight (if other than submission substance): Not reported
- Smiles notation (if other than submission substance): Not reported
- InChl (if other than submission substance): Not reported
- Structural formula attached as image file (if other than submission substance): Not reported
- Substance type: Pure active substance
- Physical state: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:

rabbit

Strain:

other: New Zealand

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 1.7-2.5 kg
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS: Details on environmental condition is not provided in the report.

Administration / exposure

Type of coverage:

not specified

Vehicle:

other: The test substance was applied in an oxidation-type hair dye base.

Details on dermal exposure:

TEST SITE: Details on test site are not provided in the report

REMOVAL OF TEST SUBSTANCE: Details on the ‘removal of test substance’ is not provided in the report.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Constant volume or concentration used: Yes
- For solids, paste formed: Not reported

VEHICLE
- Amount(s) applied: 10 ml
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported

Duration of exposure:

24h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

4-8 rabbits were tested per group (no data on sex).

Control animals:

not specified

Details on study design:

Details on the study design is not provided in the report

Statistics:

Not reported

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Not reported

Gross pathology:

Not reported

Other findings:

Not reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute percutaneous LD50 of p-toluenediamine sulfate in New Zealand rabbits was greater than 5,000 mg/kg bw.

Executive summary:

The acute percutaneous toxicity of p-toluenediamine sulfate was evaluated in a group of 4 -8 New Zealand rabbits (weight: 1.7-2.5 kg). The rabbits were shaved closely the day before the test substance was applied in 10 ml of an oxidation-type hair dye base. The period of application was 24 hours.

LD50 of p-toluenediamine sulfate was found to be greater than 5,000 mg/kg bw.