Registration Dossier
Registration Dossier
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EC number: 201-612-2 | CAS number: 85-52-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Principles of method if other than guideline:
- The principle is base on chemical reactivity of the test item with proteins.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- The method used is an in chemico recognized method (OECD442C) that allows to predict sensitizeation potential of a test item.
Test material
- Reference substance name:
- 2-benzoylbenzoic acid
- EC Number:
- 201-612-2
- EC Name:
- 2-benzoylbenzoic acid
- Cas Number:
- 85-52-9
- Molecular formula:
- C14H10O3
- IUPAC Name:
- 2-benzoylbenzoic acid
Constituent 1
In chemico test system
- Details on the study design:
- The interaction between the molecule and lysine or cysteoine rich peptides is detected with HPLC. The depletion rates of lysine and cysteine peptides (after 24 hours of incubation) are used to distinguish the skin sensitizer and non-sensitizer.
Results and discussion
- Positive control results:
- Yes : cinnamaldehyde 100mM
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- mean
- Parameter:
- other: depletion of lysine %
- Value:
- 5.07
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Depletion in cysteine %
- Value:
- 1.32
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- All validity criteria are fullfilled wich allows to validate the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitivity is determined according OECD 442C method. The study reports a mean depletion of 5.07% for lysine and 1.32% for cysteine, reflecting no or minimal reactivity and therefore a negative prediction.
- Executive summary:
The sensitivity is determined according OECD 442C method. The study reports a mean depletion of 5.07% for lysine and 1.32% for cysteine, reflecting no or minimal reactivity and therefore a negative prediction.
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