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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from publication

Data source

Reference
Reference Type:
publication
Title:
Skin irritation study of the test chemical
Author:
Sharp
Year:
1978
Bibliographic source:
Toxicology

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Preliminary irritation study of the test chemical was performed in guinea pigs to determine the concentration suitable for the sensitization study.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: alpha -Ionone
- Molecular formula: C13H20O
- Molecular weight: 192.3 g/mol
- Substance type:organic
- Physical state:liquid

Test animals

Species:
guinea pig
Strain:
Hartley
Details on test animals and environmental conditions:
Details on test animals:
- Sex: Male/female
- Weight at study initiation: 450 g
- Housing: Housed in wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): Pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): water ad libitum

Test system

Type of coverage:
not specified
Preparation of test site:
other: Intradermal application: clipped and shaved flanks Dermal application: shaved flanks
Vehicle:
other: Vehicle used but no detailed information.
Controls:
not specified
Amount / concentration applied:
Amount: 0.1 ml
concentration applied: 30%
Duration of treatment / exposure:
Duration of treatment: 24hours
Observation period:
24 hours
Number of animals:
4 (same sex)
Details on study design:
TEST SITE
- Area of exposure:
Intradermal – shaved flanks
Topical - small circular areas on the clipped, shaved flanks

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no signs of irritation were observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No signs of erythema and edema were observed at 0.1% ICC and 30% ACC concentrations. Hence, the test chemical was considered to be non-irritating on guinea pigs in the preliminary irritation tests performed for the sensitization study.
Executive summary:

Preliminary irritation tests were performed for the test chemical in guinea pigs to determine the concentration suitable for the sensitization study[injection challenge concentration (ICC) and application challenge concentration(ACC)]. In the preliminary irritation study, 4 Albino Hartley guinea pigs of the same sexwereinjected intradermally on the shaved flanks with 0.1 ml aliquots of a range of concentrations of tests material in a suitable solvent. The reactions were examined for size (two largest diameters), erythema and oedema 24 h later and the concentration giving slight but perceptible irritationwith no oedema was selected as the injection challenge concentration (ICC).0.1 ml of the test material in arange of concentrations in a suitable solvent were applied in small circular areas to the shaved flanks of 4 guinea pigs of the same sex.The reactions were examined for erythema 24 hours later and the highest concentration which caused no irritation was selected as the application challenge concentration (ACC). No signs of erythema and edema were observed at 0.1% ICC and 30% ACC concentrations. Hence, the test chemical was considered to be non-irritating to guinea pigs in the preliminary irritation tests performed for the sensitization study.