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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:
20 April 2006 - 28 April 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Méthode B4 Toxicité aiguë (irritation de la peau) de la Directive 2004/75/CE de la Commission.
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
No. 338 Red
IUPAC Name:
No. 338 Red
Details on test material:
Description: red powder
Batch number: 50670

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with distilled water
Controls:
not required
Amount / concentration applied:
Amount: 0.5 g of test material, moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
First animal: three time points, 3 minutes, 1 hour and 4 hours
Two additional animals: 4 hours
Observation period:
Approximately 1 hours following the removal of the patches and 24, 48 and 72 hours alter, the test sites were examined for evidence of primary irritation.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
1
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure; 24 hour observation not performed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 hours
Score:
0
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
0
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure; 24 hour observation not performed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 hours
Score:
0
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: pink coloured staining, 4 hours exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
other: 1-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: 4 hours exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
0
Max. score:
4
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: 3 minutes exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: 3 minutes exposure
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Pink coloured staining was noted at all treated skin site after 4 hours exposure throughout the study. The staining did not affect evaluation of skin responses.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: other: CLP, Regulation No 1272/2008
Conclusions:
Based on a skin irritation study in rabbits, the test substance is not considered skin irritating. Although pink colouration was observed after 4 hours exposure to the test substance which persisted untill the end of the observation period, the substance needs no classification according to CLP.
Executive summary:

Erythema score 1 was noted in 1 animal at 1, 24 and 48 hours after 4 hours exposure to the test substance. In the second animal, erythema score 1 was only noted at 1 hour after 4 hours exposure to the test substance. No erythema was noted in the third animal. Oedema formation was not observed in any of the animals after 4 hours exposure to the test substance.

All animals showed pink colouration of the test substance through the study period.

After 1 hour exposure to the test substance, the animal showed erythema score 1 at 1 and 24 hours. No oedema formation was observed.

After 3 minutes exposure to the test substance, no erythema nor oedema formation was noted.

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