Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: U.S. 16 CFR 1500.40
Principles of method if other than guideline:
Acute dermal toxicity test in rabbits using U.S. method dictated by 16 CFR 1500.40, similar to OECD 402.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Ten healthy NZ White rabbits were used, equally divided by sex, with body weights between 2.3 and 3.0 kg. Animals were housed individually and allowed Purina Rabbit Chow and water ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped, abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
2000 mg/kg bw. Using a body weight estimate of 2.5 kg, approximatley 5 g or 5 ml of test material was applied.
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
10 total, 5 males and 5 females
Details on study design:
The hair of the animals was clipped, and in 4/10 animals, the skin was abraded with epidermal incisions every 2-3 cm longitudinally over the application area. In the remaining animals, application of test material was made to intact skin. Each animal received a single dermal application of 2000 mg/kg bw. The test material was held in contact with the skin for 24 h by a heavy gauge plastic, covered with an opaque wrapping. After 24 h, the wrappings were removed and the skin gently wiped to remove any remaining test material. Animals were then observed for mortality and signs of irritation and toxicity frequently during the first day, and at least once daily thereafter for 14 days. Necropsy examinations were performed for gross organ pathology. Body weights were recorded initally and for survivors, at termination of the study.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
8
Reversibility:
fully reversible
Irritant / corrosive response data:
Erythema and edema was noted in all animals by the end of 24 h, and continued through 48 h as reflected in interim clinical notations. By 72 h, recovery had occurred and all animals were noted as "normal" on day 4. At the end of the study, all test sites were noted as "normal".
Other effects:
Diarrhea was noted in 4 of 10 animals. No lethality was observed in this study.

Applicant's summary and conclusion

Interpretation of results:
other: non-irritating
Conclusions:
Irritation information on the test substance was obtained in an acute dermal toxicity study in rabbits, after a 24 hour occlusive exposure. Some skin irritation was seen between 24 and 72 h, which was fully reversible by day 4. Under the conditions of the current OECD guideline, the substance is expected to be non-irritating.