N,N-bis(2-hydroxyethyl)undec-10-enamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 05, 2017 to April 07, 2017

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(2-hydroxyethyl)undec-10-enamide

EC Number:

262-114-9

EC Name:

N,N-bis(2-hydroxyethyl)undec-10-enamide

Cas Number:

60239-68-1

Molecular formula:

C15H29NO3

IUPAC Name:

N,N-bis(2-hydroxyethyl)undec-10-enamide

Test material form:

liquid

Details on test material:

The test substance is the reaction product of 10-undecenoicacid methyl ester with diethanolamine (DEA). The methanol formed in the process is removed by distillation. The final product is a clear liquid at 20 °C and 101.3 kPa.

In vitro test system

Test system:

human skin model

Remarks:

artificial three-dimensional model of human skin

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

This test method provides an in vitro procedure that, depending on information requirements, may allow determining the cytotoxic potency and skin irritancy of test substances as a stand-alone replacement test within a testing strategy, in a weight of evidence approach.

Vehicle:

unchanged (no vehicle)

Details on test system:

Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The test substance was applied as liquid test substance topically undiluted to the model skin surface.

Duration of treatment / exposure:

60 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Remarks:

cells

Run / experiment:

MTT test (mean viablility compared to the negative control - %)

Value:

6.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: prediction of irritation

Other effects / acceptance of results:

- The mean viability of cells exposed to the test substance was 6.5% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test substances of ≤50%. The test substance was considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS category 1 or 2 (H314 or H315).
- The mean optical density (OD) of 3 negative control tissues was 1.314 and was well within the acceptable range of ≥ 1.0 to ≤ 2.5. The viability of cells treated with the positive reference substance, 5% SDS, was 6.9% of the negative control and fulfilled the acceptance criterion of ≤20%.
- The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria were fulfilled.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the study conditions, the test substance was predicted to be a skin irritant.

Executive summary:

A study was conducted to determine the in vitro skin irritation potential of the test substance, C11-unsatd. DEA, according to OECD Guideline 439 and EU Method B.46 (three-dimensional reconstructed human epidermis model EpiDermTM), in compliance with GLP. The test substance was applied for 60 min in liquid form topically, undiluted, to the model skin surface (3 replicates). This was followed by a 42 h post incubation period. The optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. The mean viability of cells exposed to the test substance was 6.5% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test substances of ≤50%. The test substance was considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS classification. The mean optical density (OD) of 3 negative control tissues was 1.314 and well within the acceptable range of ≥1.0 to ≤2.5. The viability of cells treated with the positive reference substance, 5% SDS, was 6.9% of the negative control and fulfilled the acceptance criterion of ≤ 20%. The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria were fulfilled. Under the study conditions, the test substance was predicted to be a skin irritant (Spruth, 2017).