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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-920-4 | CAS number: 75-97-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Principles of method if other than guideline:
- KeratinoSens method
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- The test method described in this Test Guideline can be used to support the discrimination between skin sensitisers and non-sensitisers. The principle is based on chemical reactivity of the test item with proteins.
Test material
- Reference substance name:
- 3,3-dimethylbutanone
- EC Number:
- 200-920-4
- EC Name:
- 3,3-dimethylbutanone
- Cas Number:
- 75-97-8
- Molecular formula:
- C6H12O
- IUPAC Name:
- 3,3-dimethylbutanone
- Test material form:
- liquid
1
In chemico test system
- Details on the study design:
- OECD442 C, Protocol n°154
Results and discussion
- Positive control results:
- Positive control : cinnamaldehyde
- repettition 1 : depletion in lysine peptide = 55.63%, depletion in cysteine peptide = 71.74%,
- repettition 2 : depletion in lysine peptide = 56.47%, depletion in cysteine peptide = 71.18%,
- repettition 3 : depletion in lysine peptide = 56.48%, depletion in cysteine peptide = 71.43%,
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- mean
- Parameter:
- other: depletion in lysine peptide %
- Value:
- 5.49
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- mean
- Parameter:
- other: depletion in cysteine peptide %
- Value:
- 4.41
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- All validity criteria are fullfilled.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitivity of pinacolone i sdetermined according to OECD442C method.
the substance shows mean depletion of 5.49% for lysine and 4.41% for cysteine, reflecting no recativity and therefore a negative prediction of DPRA. - Executive summary:
The sensitivity of pinacolone i sdetermined according to OECD442C method.
the substance shows mean depletion of 5.49% for lysine and 4.41% for cysteine, reflecting no recativity and therefore a negative prediction of DPRA.
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.
