Registration Dossier
Registration Dossier
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EC number: 273-535-2 | CAS number: 68988-63-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 July 2020 - 30 July 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts
- EC Number:
- 273-535-2
- EC Name:
- Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts
- Cas Number:
- 68988-63-6
- IUPAC Name:
- Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
- Specific details on test material used for the study:
- ColaTeric CNA-40 batch/lot # 7752OI19 (31.5% active in aqueous solutions)
In chemico test system
- Details of test system:
- cysteine peptide, (Ac-RFAACAA-COOH)
- Positive control:
- cinnamic aldehyde
Results and discussion
- Positive control results:
- Pass
In vitro / in chemico
Resultsopen allclose all
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean lysine depletion
- Value:
- 0.643 %
- At concentration:
- 100 mM
- Positive controls validity:
- valid
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean cystein depletion
- Value:
- 1.79 %
- At concentration:
- 100 mM
- Positive controls validity:
- valid
- Outcome of the prediction model:
- no or minimal reactivity [in chemico]
Applicant's summary and conclusion
- Conclusions:
- The test item was classified as negative with no or minimal reactivity.
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