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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- other: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, in-house validated procedure
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Direct peptide binding assay (DPRA) performed as described in Bauch C. et al. (2011), Toxicology in Vitro 25, 1162 – 1168.
- Principles of method if other than guideline:
- Binding to Cysteine and Lysine containing model peptides in chemico
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Direct peptide binding assay
Test material
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Sovermol Pol 1100
- Test-substance No.: 14/0220-1
- Physical state: liquid
- Lot/batch No.: L82
Constituent 1
In vivo test system
Test animals
- Species:
- other: synthetic peptides (Cysteine- (C-) containing peptide: Ac-RFAACAA-COOH; Lysine- (K-) containing peptide: Ac-RFAAKAA-COOH)
Results and discussion
- Positive control results:
- All peptide was depleted by the positive control substance rthylene glycol dimethacrylate.
Any other information on results incl. tables
The mean Cysteine-peptide depletion, caused by the test substance was determined to be 4.88 %.
The mean Lysine-peptide depletion, caused by the test substance was determined to be -1.04%.
Negative depletions were considered to be “zero” for calculation of the mean peptide depletion, which was thus calculated to be 2.44%.
No co-elution of test substance and peptides was noticed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non peptide binding
- Conclusions:
- Non peptide-binding
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.
