1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.41

Principles of method if other than guideline:

The hair was removed from the lateral skin over an area of about 8 x 8 cm on both sides of the trunks of 6 rabbits with an average weight of 2.3 kg using electric clippers 24 hours before the beginning of the study. The skin on the right flank was also abraded by means of a scarifier at the site where the test patch was to be applied. Patches (2.5 x 2.5 cm) of double layers of surgical gauze were coated/impregnated with 500 mg of the test substance made into a paste with water and covered with indifferent impermeable PVC film (5 x 5 cm). The film with the patch underneath was attached to the two test sites by means of adhesive tape (Leukoflex R ) that does not irritate the skin. The whole trunk of the animals was then bandaged with an elastic fixed bandage (Elastoflex R ) for the duration of the exposure period of 24 h. The animals were restrained.Findings were reported immediately (about 30 min) after the removal of the patches (24-h value) and then 48 h and 72 h after the beginning of the study (48 h after the first reading).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(2,3-diaminophenylazo)benzene hydrochloride

EC Number:

233-314-3

EC Name:

1,3-bis(2,3-diaminophenylazo)benzene hydrochloride

Cas Number:

10114-58-6

Molecular formula:

C18H18N8.2ClH

IUPAC Name:

Basic Brown 1 HCl

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Versuchstierzuchten W. Ostrop, Meerbusch, F.R.G.- Housing: animals were housed in single cages.- Diet: "muemmel z" feed (sniff, Soest F.R.G.) ad libitum- Water: ad libitum- Acclimation period: 4-6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 16-18 °C- Humidity (%): 40%

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount applied: 500 mg

Duration of treatment / exposure:

24 h

Observation period:

8 days

Number of animals:

6

Details on study design:

TEST SITE- Area of exposure: 2.5 x 2.5 cm- Type of wrap if used: Leukoflex, ElastoflexSCORING SYSTEM: Erythema and eschar formation: Value- No erythema: 0- Very slight erythema (barely perceptible): 1- Well-defined erythema: 2- Moderate to severe erythema: 3- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Edema formation- No edema: 0- Very slight edema (barely perceptible): 1- Slight edema (edges of area weil defined by definite raising): 2- Moderate edema (raised approximately 1 mm): 3- Severe edema (raised more than 1 mm and extending beyond the area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Reading and exact calculation of the erythema index not possible because of staining of the skin caused by the test substance. Staining persisted until study end (8 days).

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: The 48-h value does not appear on the report sheet.

Any other information on results incl. tables

Reading and exact calculation of the erythema index not possible because of staining of the skin caused by the test.

Mean edema score:

	Animal No.	24h	72h	8 days	mean 24 -72 h	mean score all animals (24 - 72 h)
intact skin	1	0	0	0	0
	2	1	1	2	1
	3	0	0	0	0
	4	0	3	0	1.5
	5	1	2	2	1.5
	6	0	2	0	1
						0.83
abraded skin	1	1	0	0	0.5
	2	1	2	2	1.5
	3	1	1	0	1
	4	1	3	1	2
	5	1	2	2	1.5
	6	0	0	0	0
						1.083

Applicant's summary and conclusion

Interpretation of results:

other: Not classified under Regulation 1272/2008

Conclusions:

The analogue substance 1 was tested for skin irritation following Code of Federal Regulations, Title 16, Section 1500.41 . Under the experimental conditions the substance does not show any skin irritation potential.

Executive summary:

The analogue substance 1 was tested for skin irritation following Code of Federal Regulations, Title 16, Section 1500.41 . Under the experimental conditions the substance does not show any skin irritation potential.