3(or 4)-methylbenzene-1,2-diamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Brief study report pre-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: Code of Federal Regulations section 1500.41

Test guideline 2

Qualifier:

according to guideline

Principles of method if other than guideline:

Similar to Draize

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3(or 4)-methylbenzene-1,2-diamine

EC Number:

248-145-0

EC Name:

3(or 4)-methylbenzene-1,2-diamine

Cas Number:

26966-75-6

Molecular formula:

C7H10N2

IUPAC Name:

3(or 4)-methylbenzene-1,2-diamine

Details on test material:

The test material was administered, prepared and stored under nitrogen to prevent degradation.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Individually housed. Water available ad lib. except during the 24 hour dosing period.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Shaved, abraded and non-abraded

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

Test material prepared in water (5 parts test solution to 3 parts water w/w), and 0.5 ml introduced under a one square inch gauze patch to skin.

Duration of treatment / exposure:

24 hr

Observation period:

72 hr

Number of animals:

6

Details on study design:

0.5 ml test material introduced under a one square inch gauze patch to skin. Patches held in place by Dermical tape.
Trunks were then wrapped with rubberized cloth during the 24 hr exposure period, and the animals physically immobilised.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72h

Score:

1.25

Max. score:

1

Reversibility:

not specified

Irritant / corrosive response data:

No to slight erythema aof 72 hours and slight edema for 24 hours.
Primary irritation index obtained equaled 1.25

Other effects:

none

Any other information on results incl. tables

Individual animal data.

Scores:

0 = No erythema / edema

1 = Very slight (barely perceptible) erythema / edema

PRIMARY SKIN IRRITATION IN RABBITS

Animal Number	Erythema & Eschar		Edema
	Abraded	Non-Abraded	Abraded	Non-Abraded
1	1	1	1	1
2	1	1	1	1
3	1	1	1	1
4	1	1	1	1
5	1	1	1	1
6	1	1	1	1
Values	6	6	6	6
		72 Hour
1	1	0	0	0
2	1	0	0	0
3	1	0	0	0
4	1	0	0	0
5	1	0	0	0
6	1	0	0	0
Values	6	0	0	0
	Primary irritation index = 1.25

The PII according to the Federal Register code 1500.41 is calculated by adding the mean individual scores for erythema and edema, abraded and non-abraded, at 24 and 72 hours, and divided by four.