Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
from September to October 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions: A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
other: Shoe:Wist

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 0.9 % sodium chloride solution
Controls:
other: the untreated skin served as control
Amount / concentration applied:
549-613 mg/male animal or 420-440 mg/female animal
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females

Results and discussion

Any other information on results incl. tables

No relevant compound-related local findings were observed. The only finding was the occurrence of substance remains in male rats up to day 4, with the distribution ranging from spotty to covering the whole administration area.

The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

Applicant's summary and conclusion

Executive summary:

A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. In this studya single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations.