Registration Dossier
Registration Dossier
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EC number: 931-105-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/02/2018 - 26/06/2018
- 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
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- non animal method preferred
Test material
- Reference substance name:
- Reaction mass of L-isoleucine and octadecan-1-ol and ethanesulphonic acid and docosan-1-ol
- EC Number:
- 931-105-8
- Cas Number:
- 1156505-34-8
- Molecular formula:
- C26-30H56-64O5NS
- IUPAC Name:
- Reaction mass of L-isoleucine and octadecan-1-ol and ethanesulphonic acid and docosan-1-ol
- Test material form:
- solid
- Details on test material:
- white solid
LOT# FG9907
Constituent 1
In chemico test system
- Details on the study design:
- synthetic peptides containing cysteine or lysine were reacted with the test articles for 24hrs. After the incubation period, the extent of peptide depletion was analyzed using High Performance Liquid Chromatography (HPLC) coupled with UV spectrometric detection.
Results and discussion
- Positive control results:
- cinnamic aldehyde:
mean peptide depletion (cysteine): 70.76
mean peptide depletion (lysine): 58.85
In vitro / in chemico
Results
- Parameter:
- other: mean peptide depletion of cysteine and lysine
- Value:
- 0.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- minimal reactivity
- Other effects / acceptance of results:
- Due to lack of solubility of test article no firm conclusion can be made from the lack of reactivity
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- according to DPRA test performed on the substance, substance seems not to be a skin sensitizer. Due to lack of solubility of test article no firm conclusion can be made from the lack of reactivity
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