(2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl acrylate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in chemico

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report Date:

2018

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))

GLP compliance:

yes (incl. certificate)

Type of study:

direct peptide binding assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

In chemico test system

Details on study design:

Incubation: The appearance of the MEDOL-10 and positive control samples in the HPLC vials was documented after preparation and then the vials placed into the autosampler of the HPLC set at 25°C for a minimum of 22 hours incubation prior to initiation of the analysis run. Prior to initiation of the run the appearance of the samples in the vials was assessed and documented again.
Analysis: The concentration of both the Cysteine and Lysine peptides in the presence of MEDOL-10 and the associated positive controls was quantified by HPLC using UV detection as detailed in the chromatographic section.

Results and discussion

In vitro / in chemico

Results

Key result

Parameter:

other: depletion value

Value:

65.6

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of skin sensitisation

Remarks:

The overall depletion value of 65.6% places MEDOL-10 in the reactivity class of “high” and hence it is predicted by DPRA to be a skin sensitizer