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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Acid Navy RN-2682
IUPAC Name:
Acid Navy RN-2682
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h, then the dressing was removed and the skin was flushed with lukewarm tap water.
Observation period:
1, 24, 48, 72 h up to 7 d
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Other effects:
No clinical signs of systemic toxicity were noted and no mortality occurred.

The test item did not elicit any skin reactions at the application site.

The test item caused black staining of the treated skin in all animals from the 1-hour reading up to the 48-hour or 72- hour reading. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

The body weights of all rabbits were within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)