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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
28 March 2007 to 06 April 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 404 methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
semiocclusive
Controls:
no
Amount / concentration applied:
0.5 g of test material
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
4 animals
Details on study design:
A single 4-hour, semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

3 minute and 1-hour semi-occluded applications (0.5 g) of the test material were administered to the intact skin of one rabbit. Skin reactions were recorded 1,24, 48 and 72 hours after administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 h
Score:
ca. 0
Max. score:
8
Reversibility:
fully reversible
Irritant / corrosive response data:
non irritant
Other effects:
Skin reactions following a 4-hour exposure period: Well- defined erythema and very slght oedema were noted at one trated skin site one hour after patch removal. No evidence of skin irritation was noted at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites throughout the observation period or at the remaining treaed skiin site at the 24-hour observation.

Skin reactions following 3-minute and 1 hours exposure periods: black/purple-coloured staining was noted at all treated skin sites throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.
Therefore the tested item is to be considered as non-irritant to the skin of rabbits.
Executive summary:

The primary irritation effect on analogue substance 4 was assessed following OECD 404. The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin.