Registration Dossier
Registration Dossier
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EC number: 249-282-9 | CAS number: 28880-24-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6-4-18 to 3-8-18
- 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:
- other: DPRA
- Justification for non-LLNA method:
- in chemico/in vitro method preferred
Test material
- Reference substance name:
- Diisooctyl succinate
- EC Number:
- 249-282-9
- EC Name:
- Diisooctyl succinate
- Cas Number:
- 28880-24-2
- Molecular formula:
- C20H38O4
- IUPAC Name:
- bis(6-methylheptyl) succinate
- Details on test material:
- Purity, %DCS 99.6
Sample ID: GD1465-03
Sample Date: 04/11/2017
Constituent 1
In chemico test system
- Details on the study design:
- The Direct Peptide Reactivity Assay (DPRA) was used to assess the skin sensitizing potential of the test article. Synthetic peptides containing cysteine or lysine were reacted with the test article for 24± 2 hours. After the incubation period, the extent of peptide depletion was analyzed using High Performance Liquid Chromatography (HPLC) coupled with ultra-violet (UV) spectrometric detection.
The purpose of this study was to determine the percent of peptide depletion of the test article treated peptides compared to the controls. The laboratory phase of the study was conducted from 18 April 2018 to 27 April 2018 at the Institute for In Vitro Sciences, Inc. The test article was tested in at least one valid definitive assay to determine the reactivity classification for the test article based on the percent depletion of the peptide caused by the test article.
Results and discussion
- Positive control results:
- Cinnamic Aldehyde positive results
Mean Peptide Depletion Cysteine 75.47
Mean Peptide Depletion Lysine 60.75
In vitro / in chemico
Results
- Parameter:
- other: Mean Peptide Depletion of Cysteine and Lysine
- Value:
- 1.46
- Vehicle controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-sensitizer
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