2-nitro-p-phenylenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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, 2:3, 657-662, 1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute oral toxicity study for the test compound was conducted on groups of ten fasted Charles River CD rats. The LD50's were calculated by the method of Weil

GLP compliance:

not specified

Test type:

other: no data

Test material

Test material information

Constituent 1

Reference substance name:

2-nitro-p-phenylenediamine

EC Number:

226-164-5

EC Name:

2-nitro-p-phenylenediamine

Cas Number:

5307-14-2

Molecular formula:

C6H7N3O2

IUPAC Name:

2-nitrobenzene-1,4-diamine

Details on test material:

- Name of test material (as cited in study report): 2-nitro-p-phenylenediamine- Substance type: Organic - Physical state: Solid

Test animals

Species:

rat

Strain:

other: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Charles River- Weight at study initiation: 200-300g- Fasting period before study: fasted- Housing: No data- Diet (e.g. ad libitum): No data- Water (e.g. ad libitum): No data- Acclimation period: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Oil-in water emulsion

Details on oral exposure:

No data

Doses:

No data

No. of animals per sex per dose:

five males and five females

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 14 days (or other?): No dataFrequency of observations and weighing: No dataNecropsy of survivors performed: yes/no: YesOther examinations performed: clinical signs, body weight, organ weights, histopathology, other: No data

Statistics:

The LD50 and its 95% confidence limits were calculated from the mortality data by the method of Weil (1952).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 080 mg/kg bw

Based on:

test mat.

95% CL:

2 130 - 4 460

Remarks on result:

other: 50 % mortality

Any other information on results incl. tables

Acute Toxicity of Hair Dyes

	LD50 in rats
Compound	Oral (mg/kg)	95% confidence limits
2-Nitro-pphenylenediamine	3080	2130-4460

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material.

Executive summary:

In a acute oral toxicity study, Charles River CD rats were treated with 2-nitro-p-phenylenediamin in Oil-in water emulsion. The LD50's were calculated by the method of Weil (1952).The LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material.