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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-806-4 | CAS number: 5471-51-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-(4-hydroxyphenyl)butan-2-one
- EC Number:
- 226-806-4
- EC Name:
- 4-(4-hydroxyphenyl)butan-2-one
- Cas Number:
- 5471-51-2
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 4-(4-hydroxyphenyl)butan-2-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsD
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- DMSO
- Concentration / amount:
- 12.5%, 25% and 50% (v/v)
Challengeopen allclose all
- Vehicle:
- DMSO
- Concentration / amount:
- 12.5%, 25% and 50% (v/v)
- No. of animals per dose:
- 3
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- No. of animals per dose:
- 3
Results and discussion
Any other information on results incl. tables
None of the three tested concentrations of the test item reached the stimulation index of 3. The stimulation index at a concentration of 12.5% was 1.7 The stimulation index at a concentration of 25% was 2.0 The stimulation index at a concentration of 50% was 1.9 For individual data seeTable 6in the appendix. All animals survived throughout the test period without showing any clinical signs. Body Weight Development All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study. |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
Consequently, according to OECD 429 [4] the test item Raspberry Ketone as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.
According to Commission Regulation (EU) No 286/2011 [9] as well as GHS (Globally Harmonized Classification System) [10] the test item Raspberry Ketone has no obligatory labelling requirement for skin sensitisation and is unclassified.
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.
