Registration Dossier
Registration Dossier
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EC number: 922-576-0 | CAS number: 1184182-45-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
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:
- Salt of N-acetyl-L-glutamic acid and 1-[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine (1:1), monohydrate
- EC Number:
- 922-576-0
- Cas Number:
- 1184182-45-3
- Molecular formula:
- C18H28N2O8
- IUPAC Name:
- Salt of N-acetyl-L-glutamic acid and 1-[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine (1:1), monohydrate
- Test material form:
- solid: particulate/powder
Constituent 1
In chemico test system
- Details on the study design:
- Solutions of DEXGLUTACYCLE were successfully analyzed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. With minimal (Cysteine) and no depletion (Lysine) of either peptide (an overall mean depletion 0.15% was achieved) in the presence of DEXGLUTACYCLE
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Cysteine
- Parameter:
- other: Mean peptide depletion by DEXGLUTACYCLE (%)
- Remarks:
- The DPRA prediction and the reactivity of DEXGLUTACYCLE based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
- Value:
- 0.3
- Key result
- Run / experiment:
- other: Lysine
- Parameter:
- other: Mean peptide depletion by DEXGLUTACYCLE (%)
- Remarks:
- The DPRA prediction and the reactivity of DEXGLUTACYCLE based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
- Value:
- -0.781
Applicant's summary and conclusion
- Interpretation of results:
- other: no reactivity in either peptide therefore the prediction is a non-sensitiser
- Conclusions:
- Solutions of DEXGLUTACYCLE were successfully analysed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. There was minimal reactivity in the cysteine peptide and no reactivity in the Lysine peptide so DEXGLUTACYCLE with a mean depletion value of 0.15% is placed in the reactivity class of “no or minimal” and hence it is predicted by DPRA not to be a skin sensitizer.
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