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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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well document study using typical protocols.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Principles of method if other than guideline:
US 1964 guideline used - Federal Register 191.11, 17 September 1964.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both abraded and unabraded skin were treated
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 gram of test material was applied to each test site.
Duration of treatment / exposure:
24-hr exposure
Observation period:
Readings were taken at 24 hours, immediately after removal of wrap, and at 72 hours (48 hours post exposure).
Number of animals:
6 animals
Details on study design:
Scoring for erythema and oedema were done using a standarized 0-4 grading system as described in the guideline.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0.25
Irritant / corrosive response data:
Slight erythema was reported in all animals, more on the abraded skin than unabraded skin. No Oedema was reported.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was slight irritation in tested rabbits.
Executive summary:

There was slight irritation in tested rabbits. The reported PDII was 0.25.