Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
other: experimental study on similar substance
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: different data report by Colipa

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Different guidelines followed
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and scarified
Vehicle:
other: unchanged and water or hydropylic cream preparation
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1° Test: dye was applied at doses of 0.316, 1, 4, 3.16 and 10 g/kg
2° Test: dye was applied in a solution of 0.1, and 1% in water or hydrphylic cream preparation
Duration of treatment / exposure:
1° Test: no data
2° Test: repeated application for intact skin: 5 times a week for 13 weeks; for scarified skin: 5 times a week for 3 weeks
Number of animals:
1° Test: 4 animals for group
2° Test: 7 animals for group (intact skin); 2 animals for group (scarified skin)

Results and discussion

In vivo

Results
Irritation parameter:
other: irritant effect
Basis:
mean
Time point:
other: after 13 weeks
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The tested substance is not irritant for skin.
Executive summary:

In the first test, no irritant effects were seen on rabbit skin.

In the second test, slight to moderate irritation was noted but clinical invenstigation did not reveal any substance related effects.

Based on the test results, the tested substance is not to be considered as irritant for skin.