Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/06/2017-22/06/2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Qualifier:
- according to guideline
- Guideline:
- other: Direct peptide reactivity Assay (DPRA) for Skin Sensitization Testing, DB-ALM protocol n°154, January 12, 2013
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
- Cas Number:
- 1971906-58-7
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
- Test material form:
- liquid: viscous
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: the samples could not be measured
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In this study under the given conditions the test item could not be measured by HPLC due to the turbidity and phase separation of the samples with both peptide solutions. Therefore, the result must be considered as inconclusive.
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