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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:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
publication
Title:
Studies on the design of animal tests for the corrosiveness of industrial chemicals
Author:
Potokar M, Grundler OJ, Heusener A, Jung R, Mürmann P, Schöbel C, Suberg H and Zechel HJ
Year:
1985
Bibliographic source:
Food Chem. Toxicol. 23, 615-617

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Isophorone
- Source: Chemische Werke Hüls AG

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: New Zealand
- Sex: male / female
- Source: various breeders
- Weight at study initiation: 2-4 kg
- Number of animals: 6 (male plus female)

Environmental conditions
- animals were kept in individual cages under standardized laboratory conditions

Test system

Type of coverage:
other: semiocclusive and occlusive
Preparation of test site:
other: shorn
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted, 0.5 ml per patch
Duration of treatment / exposure:
4 hour(s)
Observation period:
Postexposure period: 7 days
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE 
- Preparation of test substance: none
- Area of exposure: laterally; shorn 15-24 hours in advance;   3 cm x 3 cm gauze pads with test substance
- Two patches were applied (one occlusive, one semi-occlusive):  air-permeable circular bandage (semi-occlusive),   
air-tight plastic foil (occlusive)
- Total volume applied: 0.5 ml per patch (corresponds to ca. 1500 mg/kg  bw)
- Postexposure period: 7 days
- Removal of test substance: each after 4 hours; rinsed with water and dried

EXAMINATIONS
- Scoring system: 5th Amendment to 67/548/EEC (1983)
- Examination time points:  1, 24, 48, 72 hours, and 7 days after removal

Results and discussion

In vivo

Results
Irritation parameter:
other: see remarks
Remarks on result:
other: the report does not mention the scores for edema and erythema; it gives only the classification for skin irritation according to EC Directive 67/548/EEC
Irritant / corrosive response data:
no data
Other effects:
No irritation was observed after occlusive and semi-occlusive application.

Any other information on results incl. tables

no futher remarks

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Directive 67/548/EEC
Conclusions:
Under the present test conditions, none of six rabbits exposed for 4 hours to 1500 mg isophorone per patch and animal (semiocclusive and
occlusive conditions) showed any test item-related changes at the examination time-points 60 minutes, 24, 48 and 72 hours after patch removal.
Executive summary:

The acute skin irritation properties of isophorone were estimated according to OECD Guideline 404. A dose of 1500 mg test item per animal was applied to the shorn, intact dorsal skin of 6 male and female rabbits under semiocclusive and occlusive conditions for 4 hours. After removal of the patches the treated skin areas were rinsed with water and dried. The results were assessed 1, 24, 48 and 72 hr after patch removal. Under the test conditions no significant irritancy to skin were observed. Therefore, isophorone is not irritating to skin.