Registration Dossier
Registration Dossier
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EC number: 936-609-1 | CAS number: -
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: Meets generally accepted scientific standards, well documented and acceptable for assessment (Draize test). Observation was performed after 24 and 72 h (no observation after 1 h and 48 h). Occlusive coverage.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
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). (Draize test)
The test substance (0.5 g) was applied on the skin (scarified and not scarified) of 6 English Silver rabbits in a occlusive dressing (gauze patch covered with a plastic film). After exposure for 24 h the patch was removed and the skin was scored at the time points 24 h and 72 h. No further observation was made. The scores were evaluated by the Draize grading scheme. The results from the scarified skin sides were not considered for the assessment of skin irritation. - GLP compliance:
- no
Test material
- Reference substance name:
- Reaction products of diazotized 2-amino-4-(methylsulfonyl)-phenol with 2-(3-Chlorophenyl)-2,4-dihydro-5-methyl-3H-pyrazol-3-one and Methyl-7-hydroxy-1-naphthylcarbamate – and chromium (III) 2:1, salted by ammonium, sodium and acid
- EC Number:
- 936-609-1
- Molecular formula:
- C40H32CrN4O12S2-R+] . [C36H28ClCrN7O10S2-R+] . [C34H26Cl2CrN8O8S2-R+]; R+ = NH4+, Na+ or H+
- IUPAC Name:
- Reaction products of diazotized 2-amino-4-(methylsulfonyl)-phenol with 2-(3-Chlorophenyl)-2,4-dihydro-5-methyl-3H-pyrazol-3-one and Methyl-7-hydroxy-1-naphthylcarbamate – and chromium (III) 2:1, salted by ammonium, sodium and acid
- Details on test material:
- Purity: No data.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: single housing V2A wire cages.
- Diet (ad libitum): NAFAG, Gossau SG, rabbit food
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: PEG 400
- Controls:
- other: untreated skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50% polyethylene glycol suspension - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 3 males/3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm2
- Type of wrap if used: gauze patch covered with a plastic film
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
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
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no findings observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no findings observed
- Irritant / corrosive response data:
- No findings were observed in any animal at any time point, neither on intact nor in sacrified skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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