Registration Dossier
Registration Dossier
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EC number: 258-904-8 | CAS number: 53988-10-6
Endpoint summary
Administrative data
Description of key information
In 2 limited studies Vulkanox MB2 (methyl-2-mercaptobenzimidazole) was tested for skin irritation/corrosion and eye irritation. The test substance was found to be not irritating to the skin and not irritating to the eye. Although the eye irritation test is limited with respect to dose (50 mg instead of 100 mg), due to the absence of any effect the study is reliable.
Additionally, a sin irritation/corrosion study and an eye irritation study with 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt (CAS 61617-00-3) as a surrogate for 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione (CAS 53988-10-6) were also negative.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Reason / purpose for cross-reference:
- reference to same study
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- 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
- 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.
Reference
The test substance proved to be not irritating to the skin
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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
- Principles of method if other than guideline:
- A dose of 50 mg of the test substance was administered into one eye of one male and one female adult New Zealand White rabbit (3-4 kg) for an exposure period of 24 hours. Then the treated eyes were rinsed with sterile water. The contralateral eye remained untreated and served as a control. The eyes were examined and the grade of the ocular reaction was recorded until day 7 according to Draize et al. (J. Pharmacol. Exp. Ther. 82, 377-390 (1944)).
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 1 day
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 animals
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 2 d, 3 d, 6 d, 7 d
- Score:
- 0
- Max. score:
- 13
- Reversibility:
- other: not applicable - score = 0 at any time point
- Other effects:
- at the inspection 1 h after the application of the test substance for 24 hours a slight redness of the treated eye (score = 1) was found. This finding was reversible within 24 h (score = 0).
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
A dose of 50 mg of the test substance was administered into one eye of one male and one female adult New Zealand White rabbit (3-4 kg) for an exposure period of 24 hours. Then the treated eyes were rinsed with sterile water. The contralateral eye remained untreated and served as a control. The eyes were examined and the grade of the ocular reaction was recorded until day 7 according to Draize et al. (J. Pharmacol. Exp. Ther. 82, 377-390 (1944)).
The test substance was not irritating to the eye (score = 0 at any time point).
Reference
The test substance proved to be not irritating to the eye
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance was tested in a 24 h skin irritation/corrosion test in rabbits not conducted according actual guidelines. The test substance (500 mg) was semi-occlusively applied once to the intact skin (inside a rabbit ear) and remained there for 24 hours. The animals were observed for 7 days after experiment. Mean value for erythema according to DRAIZE was: 0.0; mean value for edema: 0.0. The test substance was found to be not irritating.
The test substance was tested in a 24 h eye irritation test in rabbits. The test substance (50 mgl) was administered into one eye of 2 rabbits (the other eye remained untreated and served as control). The substance was washed out after 24 hours with sterile water.
The animals were observed for 7 days after experiment.
The test substance was found to be not irritating to eye.
Justification for selection of skin irritation / corrosion endpoint:
key study used
Justification for selection of eye irritation endpoint:
key study used
Justification for classification or non-classification
skin irritation:
mean value for erythema = 0, mean value for edema = 0
On the basis of this data a classification is not justified
eye irritation:
mean values for cornea opacity (0); mean values for iris inflammation (0);
mean values for conjunctivae reddening (0), mean values for conjunctivae swelling (0)
On the basis of this data a classification is not justified
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