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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

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)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- SPF Quality
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old; weights between 1.0 and 3.5 kg
- sex: males

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: solid was moistened with 0.3 mL water
Controls:
other: surrounding untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape

REMOVAL OF TEST SUBSTANCE
- 4 hours after application the dressing was removed and the skin cleaned of residual test substance using water

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:




Classification: not irritating
Executive summary:

In a study performed according to OECD 404 the test item was shown to be not irritating to rabbit's skin. No systemic intolerance reactions were observed.