Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

EC Number:

234-204-8

EC Name:

Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

Cas Number:

10595-49-0

Molecular formula:

C19H42N2O5S

IUPAC Name:

3-(dodecanoylamino)-N,N,N-trimethylpropan-1-aminium methyl sulfate

Test material form:

other: Liquid

Details on test material:

The test material was a 40% solution of the substance in water.
Sponsor's identification : RL 590/11
Description : pale yellow liquid
Storage conditions : room temperature in the dark

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on test system:

The EPISKIN model is a three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-Day culture period comprising of the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

EPISKINTM MODEL KIT
Supplier : SkinEthic Laboratories, Nice, France
Date received : 05 June 2012

Test system

Type of coverage:

open

Preparation of test site:

other: none: reconstructed human epidermis

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

As supplied: 40% solution in water

Duration of treatment / exposure:

15 minutes

Observation period:

42 hours

Number of animals:

triplicate tissues were treated with the test item

Details on study design:

The principle of the assay is based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test item by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test item treatedtissues relative to the negative controls. The concentration of the inflammatory mediator IL-1α in the culture medium retained following the 42-Hour post-exposure incubation period is also determined for test items which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end-point will be used to either confirm a non-irritant result or will be used to override the non-irritant result.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

15 minutes

Value:

40.3

Remarks on result:

other:

Any other information on results incl. tables

The MTT solution containing the test item did not turn blue which indicated that the test item did not directly reduce MTT.

Mean OD540 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item	OD540 oftissues	Mean OD540of triplicatetissues	± SD ofOD540	Relativeindividualtissueviability (%)	Relativemeanviability (%)	± SD ofRelativemeanviability (%)
Negative      Control Item	0.733	0.856	0.107	85.6	100*	12.5
	0.928			108.4
	0.906			105.8
Positive      Control Item	0.032	0.036	0.005	3.7	4.2	0.6
	0.036			4.2
	0.041			4.8
Test Item	0.326	0.345	0.030	38.1	40.3	3.5
	0.329			38.4
	0.379			44.3

SD = Standard deviation

* = The mean viability of the negative control tissues is set at 100%

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was irritating to skin in an in vitro assay.