Registration Dossier

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)

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
other: acetone
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Two animals showed very slight erythema (score of 1) one hour after patch removal.
The effects were however fully reversible within 1 day.

Any other information on results incl. tables

Although a longer exposure time than required by Annex V was employed, the UK c.a. considered the text to be acceptable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not classifed.
Executive summary:

In a test according to EU Method B.4, the test item was found to cause very slight erythema one hour after patch removal. The effects were fully reversible within 1 day.