Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
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:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: SENS-IS assay
Deviations:
no
GLP compliance:
yes
Type of study:
other: SENS-IS assay with EpiSkin model, an in vitro reconstructed human epidermis from normal human keratinocytes cultured on collagen matrix at the air-liquid interface.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

In vitro test system

Details on study design:
The test system used in this study was the EpiSkin model, an in vitro reconstructed human epidermis from normal human keratinocytes cultured on collagen matrix at the air-liquid interface. This model is histological similar to the in vivo human epidermis, with a functional horny layer.

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Number of overexpressed genes
Value:
>= 1 - <= 6
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results obtained for the positive and negative controls were within accaptance criteria and validated the study.

Regarding the sensitization biomarkers, the substance gave negative results (less than 7 genes in the "SENS-IS" or "ARE" gene group) when tested at 1, 10, 50, and 100% in olive oil.

Therefore, besed on these results, the substance Palmitoyl grapevine shoot extract did not demonstrate an in vitro sensitizing potential in the SENS-IS assay.
Executive summary:

The results obtained for the positive and negative controls were within accaptance criteria and validated the study.

Regarding the sensitization biomarkers, the substance gave negative results (less than 7 genes in the "SENS-IS" or "ARE" gene group) when tested at 1, 10, 50, and 100% in olive oil.