Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Remarks:
- h-CLAT
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 442E (Human cell line activation test (h-CLAT))
- Version / remarks:
- OECD Guideline 442E (Human cell line activation test (h-CLAT))
- GLP compliance:
- yes
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- 2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid
- Molecular formula:
- (C14H19Na2NO14S)n
- IUPAC Name:
- 2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid
Constituent 1
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: both runs
- Parameter:
- other: Relative Fluorescence Intensity (RFI) of CD86
- Value:
- 201
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Run / experiment:
- other: both runs
- Parameter:
- other: Relative Fluorescence Intensity (RFI) of CD54
- Value:
- 7 064
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Other effects / acceptance of results:
- A run conclusion is positive if at least one of the conditions below is met:
RFI of CD86 is ≥ 150 at any concentration leading to ≥ 50% viability,
RFI of CD54 is ≥ 200 at any concentration leading to ≥ 50% viability.
Any other information on results incl. tables
Solubility assessment
The test item was found soluble in 0.9% NaCl at 300 mg/mL.
Dose-Range Finding
During both DRF assays, no decrease in cell viability (i.e. cell viability < 75%) was noted in test item treated wells. No mean CV75 value was therefore calculated, and the highest tested concentration retained for the main test was 3000 µg/mL.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test item, Sulfate sodique de chondroïtine, was found to be positive in the h-CLAT assay.
However as the result of the Keratinosens assay was negative, the substance does not meet the GHS criteria for GHS classification.
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