N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.11.2019 - 11.04.2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate

EC Number:

850-698-3

Cas Number:

2387913-24-6

Molecular formula:

not applicable

IUPAC Name:

N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate

Test material form:

other: solified melt

Details on test material:

- Name of test material ((as cited in study report):
Product name: V10069,
Systemic name: Quaternary ammonium compounds, tri-C8-10-alkylmethyl-methylsulfate

Test animals

Species:

other: EpiDerm™ (EPI-200-SCT, Lot no. 25899) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.

Details on test animals or test system and environmental conditions:

EpiDerm™ is cultured from normal human keratinocytes.

Test system

Amount / concentration applied:

25 mg of test item were applied topically to the centre of the skin equivalent with a surface area of 0.63 cm2 by using a sharp spoon to uniformly cover the skin surface. The test item is a fine powder. For better contact of the test item to the skin, the skin surface was moistened with 25 μL sterile deionised water to ensure adequate contact with the skin.

Duration of treatment / exposure:

Quality control (Triton X-100, 1 % solution)
Positive control 3 min + 60 min (± 1 min) (8 N KOH)
Negative control 3 min + 60 min (± 1 min) (sterile deionised water)
Test substance 3 min + 60 min (± 1 min) undiluted

Number of animals:

The test was performed in duplicate.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Exposure: 3 min

Value:

ca. 79.4

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

exposure: 60 min

Value:

ca. 65.3

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Exposure 3 min:

Test substance: mean viability 79.4 %

Negative control: mean viability 100 %

Positive control: mean viability 6.6 %

Exposure 60 min:

Test substance: mean viability 65.3 %

Negative control: mean viability 100 %

Positive control: mean viability 6.4 %

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (duplicate)
resulted in a mean cell viability of 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure) when compared to the corresponding negative conrol. Under the present test conditions Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.

Executive summary:

The purpose of this study was to determine cytotoxic properties of Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates to skin cells, which might lead to human skin corrosion, by using an artificial three-dimensional model of human skin. The EpiDermTM model was employed.

Duplicate 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.

25 mg of test item were applied topically to the centre of the skin equivalent with a surface area of 0.63 cm2 by using a sharp spoon to uniformly cover the skin surface. The test item is a fine powder. For better contact of the test item to the skin, the skin surface was moistened with 25 μL sterile deionised water to ensure adequate contact with the skin. Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference item. An exposure time of 3 min and 60 minutes was employed.

The mean viability of cells exposed to Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates was 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure) of the negative controls and, hence, was above the cut-off percentage cell viability value that distinguishes corrosive from non-corrosive test items of > = 50%. Under the present test conditions Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.