[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO).

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Molecular formula:

C26H20.85Br1.82Na1.97N3O9S2

IUPAC Name:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Test material form:

not specified

Details on test material:

None

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: In order to prevent injuries by bites the rabbits were kept separately in V2A wire mesh cages
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

on the whole back and flanks two days before treatment with an electric clipper

Vehicle:

other: PEG 400 (Polyethylene glycol)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

FAT 40069/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 rabbits (3 males and 3 females)

Details on study design:

Rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The gauze patches were removed 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.

SCORING SYSTEM:

Erythema and Eschar Formation
- 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): 4
Total possible erythema score: 4

Edema Formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising: 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks:

Intact Skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0.5

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

None

Other effects:

None

Any other information on results incl. tables

Evaluation of the skin reactions:

Animal No. / Sex	Skin Reaction	24 hours after application		72 hours after application
		Intact skin	sacrificed skin	Intact skin	sacrificed skin
1/M	Erythema	0	0	0	0
	Oedema	0	1	0	0
2/M	Erythema	0	0	0	0
	Oedema	2	2	0	1
3/M	Erythema	0	0	0	0
	Oedema	0	1	0	0
4/F	Erythema	0	0	0	0
	Oedema	0	0	0	0
5/F	Erythema	0	0	0	0
	Oedema	0	2	0	0
6/F	Erythema	0	0	0	0
	Oedema	1	1	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40069/A is considered as non-irritant to the rabbit skin.

Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40069/A, on the skin of the rabbits according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO). Six rabbits (3 males and 3 females), Russian breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 40069/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. In conclusion, The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.5. FAT 40069/A is to be considered as a non-irritant to the skin of rabbits.