Dimethylaminopropylmethacrylamide, dodecyl bromide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in chemico

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 28-30, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.59 (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)

Version / remarks:

14/02/2017

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 442C (In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins)

Version / remarks:

2021

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

direct peptide reactivity assay (DPRA)

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide

Cas Number:

129684-50-0

Molecular formula:

C21H43N2O.Br

IUPAC Name:

N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide

Test material form:

liquid: viscous

In chemico test system

Details of test system:

cysteine peptide, (Ac-RFAACAA-COOH)

lysine peptide (Ac-RFAAKAACOOH)

Details on the study design:

The DPRA is an in chemico method which quantifies the remaining concentration of cysteine- or lysine-containing peptide following 24 ± 2 hours incubation with the test item at 25 ± 2.5 °C. The synthetic peptides contain phenylalanine to aid in the detection. Relative peptide concentration is measured by high-performance liquid chromatography (HPLC) with gradient elution and UV detection at 220 nm.
Cysteine and lysine peptide percent depletion values are then calculated and used in a prediction model, which allows assigning the test item to one of four reactivity classes used to support the discrimination between sensitisers and non-sensitisers.

Vehicle / solvent:

acetonitrile

Positive control:

cinnamic aldehyde

Results and discussion

In vitro / in chemico

Results

Key result

Group:

test chemical

Run / experiment:

mean

Parameter:

other: mean cysteine and lysine peptide depletion

Value:

1.42 %

At concentration:

100 mM

Negative controls validity:

valid

Positive controls validity:

valid

Outcome of the prediction model:

no or minimal reactivity [in chemico]

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Dimethylaminopropylmethacrylamide, dodecyl bromide revealed a mean cysteine and lysine peptide depletion of 1.42% and, hence, the test item is considered negative and predicted to be a non-sensitiser (no or minimal reactivity) in the Direct Peptide Reactivity Assay (DPRA).