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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to
Guideline:
other: JMAFF, Japanese Test Guidelines
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: moistened with water (Milli-U), immediately before application, to ensure close contact with the animal's skin
Duration of treatment / exposure:
4 hour
Observation period:
mortality: twice daily
Toxicity: at least once daily
Body weight: day of treatment (prior to application) and at termination
Irritation: 1, 24, 48 and 72 hours and 7 and 14 days in one animal, and at approximately 1, 24, 48 and 48 hours and 7, 14 and 21 days after the removal of the dressings and test substance
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24-72hours
Score:
1.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
1.3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24-72hours
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
1.3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
1.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
2
Reversibility:
fully reversible within: 7 days
Other effects:
There was no evidence of a corrosive effect on the skin.
Yellow staining of the treated skin by the test test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met