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Toxicological information

Skin sensitisation

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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:
2018

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: Relative Fluorescence Intensity (RFI) of CD86
Run / experiment:
both runs
Value:
>= 201 - <= 338
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Key result
Parameter:
other: Relative Fluorescence Intensity (RFI) of CD54
Run / experiment:
both runs
Value:
>= 7 064 - <= 14 139
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.