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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: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
publication
Title:
Interspecies Comparisons of Skin Irritancy
Author:
Nixon G, Tyson C & Wertz W
Year:
1975
Bibliographic source:
Toxicology and Applied Pharmacology 31, 481-490 (1975)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This test followed the revised Federal Hazardous Substances Act (FHSA) procedure that had been proposed by the FDA (Edwards, 1972), with a 4-hour rather than 24-hour exposure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isopropyl alcohol

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No details provided.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No details provided.
Duration of treatment / exposure:
4 hours
Observation period:
at 4, 24, and 48 hours
Number of animals:
No details provided.
Details on study design:
TEST SITE
- Area of exposure: 2 intact sites and 2 abraded sites per animal
- % coverage: not reported
- Type of wrap if used: patch (unspecified)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported


SCORING SYSTEM: see below

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4, 24, 48 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no irritation observed
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4, 24, 48 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no irritation observed
Irritation parameter:
other: tissue destruction
Basis:
mean
Time point:
other: 4, 24, 48 hr
Score:
0
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: no corrosion observed in any (0) of the 6 sites tested

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: CLP (EC 1278/2008)