Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-841-6 | CAS number: 127-41-3
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 publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin irritation study of the test chemical
- Author:
- Sharp
- Year:
- 1 978
- Bibliographic source:
- Toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- EC Number:
- 204-841-6
- EC Name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- Cas Number:
- 127-41-3
- Molecular formula:
- C13H20O
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- 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
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals or test system 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
