Registration Dossier
Registration Dossier
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EC number: 203-837-1 | CAS number: 111-13-7
Skin irritation / corrosion
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 peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- THE SENSITIZATION POTENTIAL OF SOME PERFUME INGREDIENTS TESTED USING A MODIFIED DRAIZE PROCEDURE
- Author:
- D.W. SHARP
- Year:
- 1 978
- Bibliographic source:
- Toxicology, 9 (1978) 261-271
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Preliminary irritation tests were performed in guinea pigs to determine the concentration for the sensitization study
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Octan-2-one
- EC Number:
- 203-837-1
- EC Name:
- Octan-2-one
- Cas Number:
- 111-13-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- octan-2-one
- Reference substance name:
- 2 octanone
- IUPAC Name:
- 2 octanone
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): 2 octanone
Molecular formula : C8H16O
Molecular weight:128.2134 g/mol
Substance type: Organic
Physical State: Liquid
Constituent 1
Constituent 2
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals or test system and environmental conditions:
- - 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:
- open
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml (Intradermal Concentration
- Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 24 hours
- Number of animals:
- 4 guinea pigs(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
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation observed in the [reliminary tests
Any other information on results incl. tables
SENSITIZATION POTENTIAL OF SYNTHETIC PERFUME INGREDIENTS
Non-sensitizer = no evidence of sensitization
Test chemical |
ICC(%) |
ACC(%) |
Results |
111 -13 -71.0 |
1.0 |
10 |
Not sensitizer |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- No signs of erythema and edema were observed at 1.0% ICC and 10% 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 suitableforthe 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 1.0% ICC and 10% 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.
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