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Registration Dossier
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EC number: 274-436-7 | CAS number: 70210-39-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- 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:
- yes
- Remarks:
- Compared to today's guidelines apprasive and occlusive testing conditions have been used representing elevated testing conditions
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate
- EC Number:
- 274-436-7
- EC Name:
- Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate
- Cas Number:
- 70210-39-8
- Molecular formula:
- C20H17BrN4O8S2.2Na
- IUPAC Name:
- disodium 5-({4-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-4-hydroxy-6-(methylamino)naphthalene-2-sulfonate
- Test material form:
- other: Solid
- Details on test material:
- FAT 40063/A
Constituent 1
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: kept separately in V2A wire cages
- Diet: (NAFAG, Gossau SG, rabbit food) ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- other: polyethylene glycol
- Remarks:
- PEG 400
- Controls:
- not required
- Amount / concentration applied:
- Before application a 50 % polyethylene glycol trituration (PEG 400) was made. FAT 40063/A was applied to each side in quantities of 0.5 g.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 h
- Number of animals:
- 6 rabbits (3 males/3 females)
- Details on study design:
- TEST SITE
- Area of exposure: left side of the body of rabbit
- Type of wrap if used: Gauze patch and covered with plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 72 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Scarified skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: within 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Scarified skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Scarified skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary irritation index of FAT 40063/A was 0.7
Any other information on results incl. tables
The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 h on the intact and slightly scarified skin.
Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants.
Individual Animal Score: Erythema
Animal Number |
Intact Skin |
Scarified skin |
||
|
24 h |
72 h |
24 h |
72 h |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
Individual Animal Score: Edema
Animal Number |
Intact Skin |
Scarified skin |
||
|
24 h |
72 h |
24 h |
72 h |
1 |
1 |
0 |
2 |
0 |
2 |
0 |
0 |
1 |
0 |
3 |
1 |
0 |
2 |
0 |
4 |
0 |
0 |
1 |
0 |
5 |
1 |
0 |
2 |
0 |
6 |
2 |
0 |
3 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40063/A is to be considered as a mild irritant to the skin of rabbits. According to the classification and labelling according to GHS system no classification and labelling is required.
- Executive summary:
The study was carried out to determine the primary-irritation index with the test substance (FAT 40063/A) on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "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) 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. 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 40063/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, on the basis of the evaluation scheme. The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 h on the intact and slightly scarified skin. The primary irritation index was found to be 0.7, therefore, FAT 40063/A is to be considered as a mild irritant to the skin of rabbits.
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