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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:
28 Jan - 06 Feb 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Commission Directive 2004/73/EC
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM, UK GLP Monitoring Authority

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation (kg): 2.42 - 2.82
- Housing: Individually in suspended cages provided with environmental enrichment items
- Diet: Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, UK)
- Water: Free access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g moistened with 0.5 mL distilled water
Duration of treatment / exposure:
Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h
Observation period:
Initial and confirmatory tests: 72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
Initial test: 1 male
Confirmatory test: 2 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the dorsal/flank area
- Type of wrap if used: Cotton gauze patch secured with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed·by gentle swabbing with cotton wool soaked in distilled water.

OBSERVATION TIME POINTS
1, 24, 48 and 72 h after removal of patches

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
other: mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
No evidence of skin irritation was noted during the study in any animal. Individual erythema and edema scores were 0.0 for all animals at all observation time points. Black coloured staining was noted throughout the study.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The test material produced no evidence of skin irritation to the intact skin of rabbits and was thus considered non-irritating.