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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH ≤2.0) or base (pH =>11.5)
Justification for type of information:
The objective of this study was to evaluate the ability of the test material to activate the antioxidant/ electrophile responsive element (ARE)-dependent pathway in the KeratinoSens™ assay.
The test was started with a solubility test. The test material was dissolved in Dimethyl sulfoxide to a final concentration of 200 mM (clear colourless solution). The solution was vortexed and sonicated (10 minutes with a maximum temperature of 24.5 °C) to dissolve the test material. The 100-fold dilution of the test material in Dulbecco's Modified Eagle Medium showed no precipitation (2000 µM). This concentration was therefore selected as highest test concentration for the main assay.
However, due to the fact that the test material was a strong acid the main test was cancelled: According to the consolidated version of Regulation 1907 /2006, studies for skin sensitisation do not have to be performed if the substance is a strong acid (pH<=2.0).
Therefore it is concluded that the test material is not suitable to perform the KeratinoSens™ test.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Results and discussion

Applicant's summary and conclusion