Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-11-20 to 1991-02-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
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:
shaved
Vehicle:
water
Remarks:
Distilled water
Controls:
other: The contralateral flank was similarly prepared (but without test article and vehicle) to act as a procedural control.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 100 square centimeters (10 cm x 10 cm).
- % coverage: ca. 10%
- Type of wrap if used: The dressing was wrapped around the abdomen and secured with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remaining test article was removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 h


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Reversibility of any irritating observed effect: Changes fully reversible within 2 days
No corrosion effects observed.
Other effects:
Blue staining of application sites.
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:
not irritating
Remarks:
Migrated information irritation index of 0.3 (mildly irritating) Criteria used for interpretation of results: EU
Conclusions:
The substance resulted in a primary irritation index of 0.3 (mildly irritating) when applied to the intact rabbit skin. According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC), the substance needs not be labelled as a skin irritant. The same conclusion applies to the new CLP regulation EC 1272/2008.