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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:
2005-12-22 to 2006-04-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
92/69/EC
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch: E06000594
Purity: (HPLC): 99.7 % (a/a)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Strain: Albino rabbit, Crl:KBL (NZW), female (f)
Source: Charles River Wiga GmbH, Kißlegg
Age: Approx. 15 weeks

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Aqua pro injectione
Controls:
no
Amount / concentration applied:
0.5 g of the test material mixed with several drops of Aqua pr injectione to ensure good skin contact. Single application
Duration of treatment / exposure:
4 hours
Observation period:
The rabbits were examined for skin alterations, behaviour and general condition 1 hour after removal of the patches, after 24, 48 and 72 hours, and then daily up to experimental day 8.
Number of animals:
3 females
Details on study design:
Prior to testing the pH of the preparation was determined with pH-test strips. The pH was found to be about 7. After that the test material was screened for its irritating potential using hen's egg test on the chorioallantoic membrane (HET-CAM). In the main study on primary skin irritation, 0.5 g of the test material, was mixed with some drops of Aqua pro injectione and ground in a mortar using a pestle to ensure good contact with the skin. Afterwards, the test material was spread onto 6 cm² patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin irritating potential could be detected. According to EEC Directive 2001/59 the test item does not have to be classified as a skin irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No skin irritating potential could be detected. According to CLP the test material should not be classified as a skin irritant.
Executive summary:

0.5 g of the test material was mixed with several drops of Aqua pro injectione to ensure good skin contact. The initial test with one animal and the confirmatory test with two further animals showed no signs of irritation at the treated areas following single application to the intact dorsal skin of rabbits for 4 hours under semiocclusive conditions. No signs of clinical toxicity were detected. All animals survived the observation period. Body weight development of the treated rabbits was inconspicuous. Under the conditions of the present study no signs of irritation were seen.