Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 June 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

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 Officials (AFDO)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

279-365-5

EC Name:

Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

80010-51-1

Molecular formula:

C29H28Cl2N4O7S.Na

IUPAC Name:

sodium 1-amino-4-[(3,5-bis{[(chloroacetyl)amino]methyl}-2,4,6-trimethylphenyl)amino]-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test substance: FAT 21036/A

Specific details on test material used for the study:

Name: 21036 / A
Purity: 79.9 %

Test animals

Species:

rabbit

Strain:

other: Russian Breed

Details on test animals or test system and environmental conditions:

Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. 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.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: 50 % polyethylene glycol trituration (PEG 400)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

FAT 21036/A was applied to each side in quantities of 0.5 g.

Duration of treatment / exposure:

The gauze patches were removed 24 hours after the application.

Observation period:

The reaction of the skin was appraised upon removal and 72 hours after it.

Number of animals:

3 males and 3 females

Details on study design:

FAT 21036/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.

Evaluation of Skin Reactions
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

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

scarified skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Remarks:

scarified skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 21036/A was found to be not irritating to the rabbit skin.

Executive summary:

A study was performed to determine the skin irritation potential of FAT 21036/A on Russian breed rabbits according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. 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 21036/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. No erythema or edema was observed in the study. All scores were zero. Hence, the primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore, FAT 21036/A is to be considered as not irritating to the skin of rabbits.