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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
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Referenced as Method B4 in Commision DIrective 84/449/EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Active su
Specific details on test material used for the study:
The test material was a dark brown liquid contained in a opaque plastic jar at room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three rabbits were 12 to 16 weeks old. They were individually housed in suspended metal cages. Free acess to mains drinking water and food was allowed.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: gauze patch impregnated with the material and in contact with the animal
Amount / concentration applied:
0.5 ml of test material
Duration of treatment / exposure:
4 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as NON-IRRITANT to rabbit skin. No symbol and risk phrase are therefore required.