Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study did not meet the criteria of current guidelines for skin irritation testing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test involved repeated application of 0.5 g undiluted test substance to shaved rabbit skin for 10 days (excluding weekends).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No detail available.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5g

- Concentration (if solution): undiluted

Duration of treatment / exposure:
The test material was applied daily for 10 days (excluding weekends)
Observation period:
Data not available.
Number of animals:
1
Details on study design:
TEST SITE

- Area of exposure: abdomen

- Type of wrap if used: The application sites were then covered with a semi-occlusive dressing.

Results and discussion

In vivo

Results
Irritation parameter:
other: No data available.
Irritant / corrosive response data:
The test material produced slight redness only.
Other effects:
No data available.

Any other information on results incl. tables

The report did not provide the severity score for redness or the time of its onset and reversibility.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Based on the available information from a non-standard study, D3 is not irritant to rabbit skin following repeated application.