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EC number: 275-031-8 | CAS number: 70942-01-7
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:
- other: Study conducted according to internationally accepted testing guidelines, well documented and the results scientifically acceptable. Some minor details missing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- 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).
- GLP compliance:
- no
- Remarks:
- Pre GLP.
Test material
- Reference substance name:
- Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 275-031-8
- EC Name:
- Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 70942-01-7
- Molecular formula:
- C40H44KN12NaO10S2
- IUPAC Name:
- potassium sodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt Sulzfeld, Germany.
- Age at study initiation: adult.
- Weight at study initiation: 1.5 to 2.
- Housing: individually housed in metal cages.
- Diet: ad libitum, standard rabbit food NAFAG, Gossau SG.
- Water: ad libitum.
- Acclimation period: for a minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: constant room temperature of 22 ± 1 °C
- Humidity: relative humidity of 55 ± 5 %
- Photoperiod: 10 hrs light cycle day.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact shaved skin.
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Gauze of 2.5 x 2.5 cm laden with 0.5 ml of the test substance were applied to the prepared abraded and intact skin.
- Duration of treatment / exposure:
- The dressing were removed after a 24 hrs application.
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females.
- Details on study design:
- TEST SITE
- Area of exposure: before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified.
- Type of wrap if used: patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
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 (beef redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4
Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact and abraded skin
- Irritant / corrosive response data:
- Primary irritation index was estimated to be 0.83; minimal irritating.
Any other information on results incl. tables
Evaluation of skin reaction
| Animal | Skin site | Parameter | hrs | days | Mean 24, 48 and 72 hrs | |||
| 24 | 48 | 72 | 4 | 7 | ||||
| 1M | Intact skin | Erythema | 0 | 0 | 0 | 0 | 0 | 0.00 |
| Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | ||
| Abraded skin | Erythema | 1 | 1 | 0 | 0 | 0 | 0.67 | |
| Oedema | 1 | 1 | 0 | 0 | 0 | 0.67 | ||
| 2M | Intact skin | Erythema | 0 | 0 | 0 | 0 | 0 | 0.00 |
| Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | ||
| Abraded skin | Erythema | 1 | 1 | 1 | 1 | 0 | 1.00 | |
| Oedema | 1 | 1 | 1 | 1 | 0 | 1.00 | ||
| 3M | Intact skin | Erythema | 0 | 0 | 0 | 0 | 0 | 0.00 |
| Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | ||
| Abraded skin | Erythema | 1 | 1 | 1 | 0 | 0 | 1.00 | |
| Oedema | 1 | 1 | 1 | 0 | 0 | 1.00 | ||
| 4F | Intact skin | Erythema | 0 | 0 | 0 | 0 | 0 | 0.00 |
| Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | ||
| Abraded skin | Erythema | 1 | 1 | 1 | 0 | 0 | 1.00 | |
| Oedema | 1 | 1 | 1 | 0 | 0 | 1.00 | ||
| 5F | Intact skin | Erythema | 0 | 0 | 0 | 0 | 0 | 0.00 |
| Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | ||
| Abraded skin | Erythema | 1 | 1 | 1 | 1 | 0 | 1.00 | |
| Oedema | 1 | 1 | 1 | 1 | 0 | 1.00 | ||
| 6F | Intact skin | Erythema | 0 | 0 | 0 | 0 | 0 | 0.00 |
| Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | ||
| Abraded skin | Erythema | 1 | 1 | 0 | 0 | 0 | 0.67 | |
| Oedema | 1 | 1 | 0 | 0 | 0 | 0.67 | ||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating.
- Executive summary:
Method
The skin irritation potential was assessed following the procedure of 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).
Results
Primary irritation index was estimated to be 0.83, therefore the substance resulted minimal irritating.
Discussion and conclusion
The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008), because the raw tables are included into the study report. Only the intact skin reactions were considered.
Mean values from grading at 24, 48 and 72 hours after patch removal were 0 in all animals for both erythema/eschar and oedema reactions.
In conclusion, the test item is not classified as irritating, according to the CLP (EC 1272/2008) Regulation.
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