Registration Dossier
Registration Dossier
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EC number: 604-582-2 | CAS number: 1472-93-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-11-15 to 2011-11-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In vitro skin irritation: reconstructed human epidermis test method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31
Test material
- Reference substance name:
- methyl 9-decenoate
- EC Number:
- 662-772-0
- Cas Number:
- 25601-41-6
- Molecular formula:
- C11H20O2
- IUPAC Name:
- methyl 9-decenoate
- Test material form:
- liquid
- Details on test material:
- Description: clear colourless liquid
Batch number: 184-109
Purity: 99%
Date received: 01 April 2011
Constituent 1
Test animals
- Species:
- other: not applicable
- Strain:
- not specified
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- not specified
- Controls:
- other: not applicable
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: relative viability of treated tissues
- Value:
- 68.8
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Remarks: ± 13.7 Percent . (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was determined to be non-irritant.
- Executive summary:
An in vitro study was performed to assess the skin irritation potential of the test item, using the EPISKIN™ reconstructed human epidermis model, according to OECD Guideline 439, in compliance with GLP. The potential was observed after a treatment period of 15 minutes followed by a postexposure incubation period of 42 hours. The relative mean viability of the test item treated tissues was 68.8 % after the 15 minute exposure period. The test item, 9-decenoic acid, methyl ester was therefore considered to be non-irritant (Harlan Laboratories Ltd, 2012).
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.
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