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Toxicological information

Skin irritation / corrosion

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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 without detailed documentation

Data source

Reference
Reference Type:
other: reference to SNIF-file
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
not specified
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
4 h
Observation period:
76 h
Number of animals:
6
Details on study design:
Test sites were covered with a watch glass of 1 inch diameter to ensure good skin contact.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritant / corrosive response data:
Abraded skin:
- mean scores for erythema and oedema respecitvely for all animals (4/28/52/76 h):
0.3-0/0.2-0/0.2-0/0-0
Maximum score for one animal 1-0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No skin irritation was observed in a study conduceted according to OECD 404 in rabbits. After an observation period of 76 hours, for intact skin all scores for erythema and edema were 0.
For abraded skin very slight erythema with a maximum score of 1 in one animal was observed. Effects were fully reversible within 76 hours.

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