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Toxicological information

Skin irritation / corrosion

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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:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977
Reference Type:
publication
Title:
Acute toxicologic evaluation of methylmercaptobenzimidazole
Author:
Bomhard E, Loeser E
Year:
1996
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Versuchsprodukt KA 9059 = Vulkanox MB-2/MG; no further data

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.