Registration Dossier
Registration Dossier
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EC number: 941-245-1 | CAS number: 1689576-43-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- other: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: In-house validated in vitro study, reported as summary, non-GLP
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:
- 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:
- no
- Type of study:
- other: Direct peptide binding assay
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): 2-(2-Methylallyl)-cyclododecanon-Rein
- Physical state: Liquid/ colorless, clear
- Analytical purity: 99.3 area-% (not corrected with the water content), Capillary GC-analysis
- Lot/batch No.: 2-(2-Meth-allyl)cyclododecanon (MACD Probe aus B410.16 vom 04.10.2012)
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on test animals and environmental conditions:
- not applicable
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: not applicable
- Vehicle:
- other: not applicable
- Concentration / amount:
- Test substance was solved at a 100 mM concentration in acetonitrile.
Test substance were incubated with each peptide in ratios of 1:10 (for C-peptide) or 1:50 (for K-peptide).
Challengeopen allclose all
- Route:
- other: not applicable
- Vehicle:
- other: not applicable
- Concentration / amount:
- Test substance was solved at a 100 mM concentration in acetonitrile.
Test substance were incubated with each peptide in ratios of 1:10 (for C-peptide) or 1:50 (for K-peptide).
- No. of animals per dose:
- not applicable
- Details on study design:
- not applicable
- Challenge controls:
- not applicable
- Positive control substance(s):
- yes
- Remarks:
- EGDMA
Results and discussion
- Positive control results:
- The mean Cysteine-peptide depletion, caused by the PC was determined to be 50.7 %.
The mean Lysine-peptide depletion, caused by the PC was determined to be 13.94%.
Any other information on results incl. tables
The mean Cysteine-peptide depletion, caused by the test substance was determined to be 5.61%.
The mean Lysine-peptide depletion, caused by the test substance was determined to be -3.21 %.
No co-elution of test substance and peptides was noticed.
The samples of the test substance with the peptides were emulsions directly after application and after the 24-hour incubation time. Thus
the samples were centrifuged prior to HPLC analysis.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non peptide binding
- Conclusions:
- In a weight of evidence, all present in vitro data on dermal sensitization do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.
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