Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recently conducted guideline study to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

IUPAC Name:

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

Test material form:

liquid: viscous

Details on test material:

Sponsor's identification: RL 590/11
Description: pale yellow liquid
Lot number: 1023J29202
Purity: not supplied
Date received: 30 March 2012
Expiry date: 31 December 2012
Storage conditions: room temperature in the dark

Test animals

Species:

other: reconstructed human epidermis

Strain:

not specified

Details on test animals or test system and environmental conditions:

The purpose of this test is to evaluate the corrosivity potential of the test item using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) Model. The EPISKIN™ model is able to distinguish between corrosive and non-corrosive chemicals for all of the chemical types studied, and is also able to distinguish between known R35 (UN packing group I) and R34 (UN packing group II & III) test items.

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:

50 µL

Duration of treatment / exposure:

3, 60 and 240 minutes

Details on study design:

The procedure followed is based on the recommended EpiSkin™ Skin Corrosivity Test protocol INVITTOX N° 118(5) The test item is applied topically to the stratum corneum surface, at the air interface, so that undiluted and/or end use dilutions can be tested
directly. The test is based on the experience that corrosive chemicals are cytotoxic after a short term exposure to the EPISKIN™ model. Corrosive chemicals are able to penetrate the stratum corneum and are sufficiently cytotoxic to cause cell death in the underlying cell layers. Toxicity is determined by the metabolic conversion of the vital dye MTT to formazan by viable cells in the test item treated cultures relative to the negative control.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: percentage relative viability

Run / experiment:

240 minutes

Value:

ca. 106.7

Remarks on result:

other: MTT reduction in the test item treated issues relative to negative control tissues

Results 2

Irritation / corrosion parameter:

other: percentage relative viability

Run / experiment:

60 minutes

Value:

ca. 125.5

Remarks on result:

other: MTT reduction in the test item treated tissues relative to negative control tissues

Results 3

Irritation / corrosion parameter:

other: percentage relative viability

Run / experiment:

3 minutes

Value:

ca. 132.7

Remarks on result:

other: MTT reduction in the test item treated tissues relative to negative control tissues

Any other information on results incl. tables

Table 1 - Mean 0D₅₄₀ Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item

Item	Exposure Period	Mean OD540 of duplicate tissues	Relative mean viability (%)
Negative Control Item	240 minutes	0.208	100*
Positive Control Item	240 minutes	0.037	17.8
Test Item	240 minutes	0.222	106.7
	60 minutes	0.261	125.5
	3 minutes	0.276	132.7
* The mean viability of the negative control tissues is set at 100%

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The substance was non-corrosive to the skin.

Executive summary:

The corrosivity potential of CAS# 10595 -49 -0 was evaluated using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to be compatible with OECD Guideline 431 and Method 8.40 of (EC) No. 440/2008.

At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-Ioading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.

At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density (OD) was measured at 540 nm (OD₅₄₀).

Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).

Results: The relative mean viability of the test item treated tissues was:

240 minutes exposure: 106.7 %

60 minutes exposure: 125.5 %

3 minutes exposure: 132.7 %

Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.

Conclusion: The test item was considered to be Non-Corrosive to the skin.