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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:
9 December to 12 December 2003.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Free access to food and mains drinking water.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Arachis oil BP
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g test material moistened with 0.5 mL arachis oil.
Duration of treatment / exposure:
Four hours
Observation period:
72 hours.
Number of animals:
3
Details on study design:
2.5 x 2.5 cotton gauze was secured in position with surgical adhesive tape, and wrapped in an elasticated corset.
Four hours after application the corset and patches were revoved from the animal and residual test material removed by swabbing with cotton wool soaked in distilled water.
Examination of the test site occured 1, 24, 48 and 72 hour after exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
PII = 0.5 (mild irritant)
Basis:
mean
Time point:
72 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
4 h semi-occluded exposure to rabbit skin produced no evidence of skin irritation.