4-Methyl-N-[3-(triethoxysilyl)propyl]-2-pentanimine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in chemico

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2017 - 22 december 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

February 4, 2015

GLP compliance:

yes (incl. QA statement)

Type of study:

direct peptide reactivity assay (DPRA)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

467-100-8

EC Name:

-

Cas Number:

116229-43-7

Molecular formula:

C15H33NO3Si

IUPAC Name:

(E)-(4-methylpentan-2-ylidene)[3-(triethoxysilyl)propyl]amine

Test material form:

liquid

In chemico test system

Details on the study design:

The in chemico direct peptide reactivity assay (DPRA) enables detection of the sensitising potential of a test item by quantifying the reactivity of test chemicals towards synthetic peptides containing either lysine or cysteine.
In the present study N-(1,3-Dimethylbutylidene)-3-(triethoxysilyl)propylamine was dissolved in acetonitrile, based on the results of the pre-experiments.
Based on a molecular weight of 303.51 g/mol a 100 mM stock solution was prepared. The test item solutions were tested by incubating the samples with the peptides containing either cysteine or lysine for 24 ± 2 h at 25 ± 2.5 °C. Subsequently samples were analysed by HPLC.
All test item solutions were freshly prepared immediately prior to use.

Results and discussion

In vitro / in chemico

Results

Key result

Parameter:

other: Depletion of the synthetic cysteine peptide (%)

Value:

15.25

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of skin sensitisation

Remarks:

According to the evaluation criteria in the guideline, for test items with a cysteine peptide depletion between 9% and 17% a second run should be considered. This has not been carried out and, therefore, no definite prediction could be made.

Other effects / acceptance of results:

Turbidity in the lysine experiment was observed. Therefore, the given peak areas and corresponding lysine peptide values can only be considered as an estimation of the peptide depletion and cannot be used for evaluation.
Sensitising potential of the test item was predicted from the mean peptide depletion of the cysteine peptide by comparing the peptide concentration of the test item treated samples to the corresponding reference control C (RC Cacetonitrile).
The 100 mM stock solution of the test item showed low reactivity towards the synthetic peptides. The mean depletion of the cysteine peptide was > 13.89% (15.25%). Based on the prediction model 2 the test item can be considered as sensitiser.
See attachment for data tables.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria