Registration Dossier

Administrative data

Description of key information

The test substance ZMBT showed a practically non-irritating potential to rabbit skin (Monsanto Co. 1975). The even very low skin irritation potential is confirmed by another skin irritation study (TNO 1976). A low eye irritation potential of ZMBT was revealed in an eye irritation study with New Zealand albino rabbits (Monsanto Co 1975). The low potential was confirmed in another eye irritating study (TNO 1976).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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: limited but acceptable documented study report which meets basic scientific principles
Principles of method if other than guideline:
Method: other: primary skin irritation study, 24 hours exposure; 7-d observation period
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h, 72 h
Score:
0
Max. score:
8
Reversibility:
other: no effects
Remarks on result:
other: no skin irritating effects observed

No skin irritating effects observed in any of the treated animals.

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

The skin irritation potential of the test substance ZMBT was evaluated in a skin irritation study with six New Zealand Albino rabbits. The finely ground test substance (0.5 mg) moistened with water was applied under semi-occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours. A 7 day observation period followed the test substance application. The test substance ZMBT was practically non-irritating to rabbit skin (mean irritation score intact and abraded skin 24 and 72 h average: 0).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

Non-human information

The skin irritation potential of the test substance ZMBT was evaluated in a skin irritation study with six New Zealand Albino rabbits (Monsanto Co.1975). The finely ground test substance (0.5 mg) moistened with water was applied under semi-occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours. A 7 day observation period followed the test substance application. The test substance ZMBT was practically non-irritating to rabbit skin (mean irritation score intact and abraded skin 24 and 72 h average: 0).

The very slight skin irritating effect of ZMBT was confirmed by another skin irritating study with rabbits (TNO1976). The primary irritation to the skin was measured by a patch-test technique on the abraded and intact skin of albino rabbits. Twelve healthy adult New Zealand White albino rabbits were used. An amount of 0.5 g of the test substance was brought on the intact or abraded skin. Six rabbits were treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions were evaluated. A second reading was made 48 hours later (72 hours after application). Slight and transient skin irritating effects were noted in half of the treated animals, indicated by an average score of 1.0/8 for intact skin and an average score of 1.3/8 for abraded skin. The effects were reversible within 72 hours.

Eye

Non-human information

The eye irritating potential of the test substance ZMBT was evaluated in an eye irritation study with six New Zealand albino rabbits (Monsanto Co 1975). The finely ground test substance (100 mg) was placed into eyes of six rabbits. A 7-day observation period followed the application of the test substance. Eye response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964).

The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 1.8/110.0). Effects on the conjunctivae were noted in all animals at 1 and 24 hours (mean score 1 h: 7.3/110, 24 h: 5.3/110) but were reversible within 48 hours. The test substance was not classified as eye irritating.

The slight and transient eye irritating effects of ZMBT was also observed in another eye irritation study (TNO 1976). Six New Zealand White albino rabbits were used for the test. The test substance (100 mg) was administrated in one eye of each rabbit; whereas the other eye of each rabbit remained untreated and served as control. The eyes are not washed following instillation. The eyes were examined at 24, 48 h, 72 h and 7 days after instillation of the test material. Slight and transient effects on the conjunctivae were noted 24 hours after instillation of the test substance (conjunctivae mean score at 24 h: 0.7/3, chemosis mean score at 24 h: 0.2/4). The effects were fully reversible within seven days.

Justification for classification or non-classification

No classification is required according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).