Registration Dossier
Registration Dossier
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EC number: 807-586-4 | CAS number: 634602-80-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Oxirane, [(4-nonylphenoxy)methyl]-, reaction product with ethylene glycol
- EC Number:
- 807-586-4
- Cas Number:
- 634602-80-5
- Molecular formula:
- UVCB - so Molecular formula i snot applicable
- IUPAC Name:
- Oxirane, [(4-nonylphenoxy)methyl]-, reaction product with ethylene glycol
- Test material form:
- liquid: viscous
- Remarks:
- Reddish-Brown
- Details on test material:
- Lot #: LL6I0011
Constituent 1
Results and discussion
- Positive control results:
- Cysteine depletion: 74.60
Lysine depletion: 62.52
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: mean of all runs
- Parameter:
- other: Cysteine depletion
- Value:
- 2.05
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: mean of all runs
- Parameter:
- other: Lysine depletion
- Value:
- 0.49
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the Direct Peptide Reactivity Assay for the test article was not predicted to be a potential skin sensitizer.
- Executive summary:
The Direct Peptide Reactivity Assay was used to assess the skin sensitization potenetial of the test substance. The skin sensitization potential of the test substance was evaluated by measuring the depletion of synthetic peptides containing either cysteine or lysine aminoacids following incubation with the test substance, using the protocol that is consistent with the OECD Test Guideline 442C “In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)”[1]. Based upon the results of this study, the test substance, was not classified as a skin sensitizer.
[1] OECD Test Guideline 442C “In ChemicoSkin Sensitization: Direct Peptide Reactivity Assay (DPRA)”, Adopted 4 February 2015.
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