Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
BASF-Testing method
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
to form a paste
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 50%
Duration of treatment / exposure:
Back: 20 hours
Observation period:
24 hours and 8 days
Number of animals:
not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 8 days
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h/8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Conclusions:
Slight reddening of the skin was obderved after 24 hours, but not after 8 days. The test item is not irritating to skin.