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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:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity; 95.6 % w/w

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
single treatment
Observation period:
14 days
Details on study design:
The cutaneous reactions were assessed immediately after removal of the patch,
approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals
until day 14.

Results and discussion

Any other information on results incl. tables

The following test item-related clinical observations were recorded during the course of

the study:

· Very slight to well-defined erythema (grade 1-2)

The cutaneous reactions were reversible in one animal within 72 hours and in another animal within 7 days after removal of the patch. In the third animal very slight erythema was still observed on day 14 (study termination).

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU