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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:
2001-09-18 to 2001-09-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
at the time of conducting this study a regulatory approved in vitro study was not available.

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)
Version / remarks:
Adopted July 17, 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Adopted July 31, 1992
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Test Animals
- Strain: Crl:KBL(NZW)BR (N.Zeal.White)
- Source: Cherles River GmbH, Kißlegg, Germany
- Diet: ssniff K-H (V2333), ad libitum and hay
- Water: tap water, ad libitum
- Body weight at start of the study: 3.27-3.79 Kg
- Acclimation oeriod: 1 week under study conditions
- Housing: in fully air-conditioned rooms in seperate cages arranged in a battery


Environmental Conditions
- Temperature: 20 +/- 3 °C
- Relative humidity: 50 +/- 20%
- Photoperiod:12 hours light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Test material:
0.5 mL test item
Duration of treatment / exposure:
one administration 4 hours
Observation period:
3 days
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Exposure: 0.5 mL test item, semi-occlusive, 4 hours

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with warm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: as in OECD TG 404 described, reading at 1, 24, 48 and 72 h after removal of test item.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
three animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
three animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

To assess the skin irritation potential of the test item an in vivo skin irritation test in New Zealand White rabbits was performed regarding to OECD TG 404. Based on the result of this study the test item is not irritating to skin according to th eclassification criteria of Directive 93/21/EEC.