Registration Dossier
Registration Dossier
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EC number: 945-989-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
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))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Condensation products of N-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid
- EC Number:
- 945-989-8
- IUPAC Name:
- Condensation products of N-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid
- Test material form:
- solid: crystalline
Constituent 1
In chemico test system
- Details on the study design:
- The DPRA is an in chemico method, which quantifies the remaining concentration of Cysteine or Lysine containing peptide, following 24 ± 2 hours incubation with the test item at 25 ± 2.5 ºC. The synthetic peptides contain phenylalanine to aid in the detection. Relative peptide concentration is measured by high-performance liquid chromatography (HPLC) with gradient elution and UV detection at 220 nm. Cysteine and Lysine peptide percent depletion values are calculated and used in a prediction model which allow assigning the test item to one of four reactivity classes used to support the discrimination between sensitizers and non-sensitizers.
Results and discussion
- Positive control results:
- Cinnamaldehyde used as positive control (PC) at a concentration of 100 mM in acetonitrile. The results were as expected.
In vitro / in chemico
Results
- Key result
- Run / experiment:
- other: DPRA
- Parameter:
- other: DPRA
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Due to the low water soulbility of 0.00022mg/L no effect was observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Water Solubility of <0.00013 mg/l meant it was not possible to test according to DPRA
- Conclusions:
- Due to the the water solubility of 0.00022 mg/L no depletion of Cysteine or Lycine was observed.
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