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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:
From March 6th to 21st, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Blue REg 6080
IUPAC Name:
Blue REg 6080

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
test item was moistened with bi-distilled water before application
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 h and 7 d after removal of the dressing
Number of animals:
1 male and 2 females
Details on study design:
Skin reactions assessed according to Draize score system (EEC Comission Directive 92/69/EEC).

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
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
COLORATION: slight grey staining of the treated skin was noted one day after treatment up to 48 hours (one male) and 72 hours respectively.

MORTALITY/CLINICAL SIGNS: no mortality and no clinical signs observed.

Applicant's summary and conclusion

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