m-phenylenediamine

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:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guide to Labeling of Dangerous Substances published in the Official Journal of European Communiites (EEC Directive 93/21, Annex VI).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

m-phenylenediamine

EC Number:

203-584-7

EC Name:

m-phenylenediamine

Cas Number:

108-45-2

Molecular formula:

C6H8N2

IUPAC Name:

m-phenylenediamine

Details on test material:

- Purity: 99%
-Physical Form: Purple to black flake.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Hare Marland, Hewitt, New Jersey.
Housing: Single, in suspended, stainless steel, wire-mesh cages.
Food: Purina Certified High Fiber Rabbit Chow #5325, ad libitum, except during exposure.
Water: Ad libitum except during exposure.
Weight: 2074-2162 g
Light/Dark Cycle: 12/12
Temperature: 20ºC ± 1
Humidity: 50% ± 10%

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: other areas on test animals' body was used for comparison (control)

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, and 48 hours

Number of animals:

6

Details on study design:

On the day prior to treatment, the hair of 6 male rabbits was closely shaved to expose the skin from the scapular to the lumbar region of the back. Each rabbit was placed into a stock which had been fitted with a piece of rubber sheeting, approximately 8" x 18". The rabbits remained in the stocks throughout the exposure period and during that time did not have access to food or water. Approximately 0.5 g of the test substance, moistened with deionized water prior to dosing, was applied directly to the test site and was covered with a 2" gauze square. The gauze square was held in place with non-irritating tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact with the skin without undue pressure. Approximately 4 hours after application of the test substance, the rubber sheeting was loosened, and the skin at the corners of the gauze squares was marked with a waterproof pen. Wrappings and gauze squares were then removed. The test sites were gently washed with soap and warm water to remove excess test substance. The skin was gently patted dry and the animals were returned to their cages. Approximately 1, 24, and 48 hours after removal of the test substance, the test sites were evaluated for erythema, edema, and other evidence of dermal effects and were scored according to the Draize scale. The adjacent areas of the untreated skin were used for comparison. Additionally, the rabbits were examined for clinical signs of toxicity at each dermal evaluation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

1.5

Max. score:

4

Reversibility:

other: not reversible in 48 hours

Remarks on result:

other: Evaluations made up to 48 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48 h

Score:

1.5

Max. score:

4

Reversibility:

other: not reversible in 48 hours

Remarks on result:

other: Evaluations made up to 48 hours

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other: Evaluations made up to 48 hours

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluations made up to 48 hours

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other: Evaluations made up to 48 hours

Irritant / corrosive response data:

The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed. By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema. Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.
See results tables 1 and 2 for further details.

Other effects:

In addition, the test sites of 2 rabbits were stained gray by the test substance. No clinical signs of toxicity were observed during the study.

Any other information on results incl. tables

TABLE 1: Summary of Skin Response to the test substance
	Erythema			Edema
Response	1 hr	24 hr	48 hr	1 hr	24 hr	48 hr
None	0/6	0/6	4/6	6/6	2/6	6/6
Slight	3/6	2/6	2/6	0/6	4/6	0/6
Mild	3/6	4/6	0/6	0/6	0/6	0/6
TABLE 2: Individual Skin Irritation Scores Skin Response Observed in Rabbits
Rabbit	Erythema			Edema
Number	1 hr	24 hr	48 hr	1 hr	24 hr	48 hr
30374	1	2	1	0	1	0
30383	1(x)	1(x)	0(x)	0	0	0
30384	2	2	0	0	1	0
30385	2(x)	2(x)	0(x)	0	1	0
30386	2	2	1	0	1	0
30392	1	1	0	0	0	0
(x) = skin stained gray

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed.  By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema.  Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.

Executive summary:

The irritation potential of the test substance was studied in rabbits. The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed.  By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema.  Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.