Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August-December 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline study; not GLP-compliant
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; deviated from Annex V (observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: amber liquid
Details on test material:
- Test Material: C-1054
- Description: Amber liquid
- Date Received: August 7, 19B6
- Storage: Temperature - monitored room (60-85°F)
- Density: 1.2208 g/ml

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
Observation only at 72 hours
Number of animals:
4 animals were used
Details on study design:
Observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item produced very mild dermal irritation. Only one of the four animals exhibited very slight (barely perceptible) erythema at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be non-irritant to rabbit skin.
Executive summary:

The skin irritation test was performed according to EU-testing method B.4, using 4 NZW-rabbits. Deviated from Annex V (observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period). Very slight erythema (grade I) was observed in one animal at 72 hours. The test item was found to be non-irritant to rabbit skin.