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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 22 to October 25, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Red RA 10463
IUPAC Name:
Red RA 10463

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
area of 10 × 15 cm^2 using electric clippers ca. 24 hours before exposure
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g of test substance, moistened
Duration of treatment / exposure:
4 hours, after which time the substance was removed
Observation period:
72 hours
Number of animals:
3 males

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:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation/corrosion was observed in any animal during the study period.
Other effects:
No symptoms of systemic toxicity were observed in any animal during the study period, however, purple staining was observed in all three animals at 1 and 24 hours after the end of the exposure period.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritating to skin.