Registration Dossier
Registration Dossier
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EC number: 258-904-8 | CAS number: 53988-10-6
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: sufficient documented and scientifically acceptable
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- publication
- Title:
- Acute toxicologic evaluation of methylmercaptobenzimidazole
- Author:
- Bomhard E, Loeser E
- Year:
- 1 996
- Bibliographic source:
- J Am Coll Toxicol 15, S65
Materials and methods
- Principles of method if other than guideline:
- 500 mg of the test substance were semi-occlusively applied once to the intact skin onto the inside of the ear of one male and one female young adult New Zealand White rabbit (3-4 kg) for an exposure period of 24 hours. Evaluation of skin irritation was made until day 7 according to Draize et al. (J.Pharmacol. Exp. Ther. 82, 377-390 (1944).
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione
- EC Number:
- 258-904-8
- EC Name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione
- Cas Number:
- 53988-10-6
- Molecular formula:
- C8H8N2S
- IUPAC Name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione
- Details on test material:
- Versuchsprodukt KA 9059 = Vulkanox MB-2/MG; no further data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: application at the inside of the ear
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- other: 1 h, 24 h, 4 d, 5 d, 6 d, 7 d
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable - score = 0 at any time point
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- other: 1 h, 24 h, 2 d, 3 d, 6 d, 7 d
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable - score = 0 at any time point
- Other effects:
- no data
Any other information on results incl. tables
The test substance proved to be not irritating to the skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
- 500 mg of the test substance were semi-occlusively applied once to the intact skin onto the insideof the ear of one male and one female young adult New Zealand White rabbit(3-4 kg) for an exposureperiod of 24 hours. Evaluation of skin irritation was made until day 7 according to Draize et al.(J.Pharmacol. Exp. Ther. 82, 377-390 (1944). The test substance proved to be not irritating to the skin.
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