N-(1-oxotetradecyl)sarcosine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

9 Dec 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in March 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Version / remarks:

adopted in April 2000

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-lauroylsarcosine

EC Number:

202-608-3

EC Name:

N-lauroylsarcosine

Cas Number:

97-78-9

Molecular formula:

C15H29NO3

IUPAC Name:

N-dodecanoyl-N-methylglycine

Test material form:

other: waxy solid

Test animals

Species:

other: human

Strain:

other: EpiDermTM Skin Corrosivity Test; reconstructed three-dimensional human epidermis (EPI-200)

Test system

Type of coverage:

other: in vitro system

Preparation of test site:

other: intact reconstructed human epidermis

Vehicle:

unchanged (no vehicle)

Controls:

other: concurrent control tissues treated with distilled water served as negative controls, positive controls were exposed to potassium hydroxide.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL

NEGATIVE CONTROL SUBSTANCE
- Amount(s) applied (volume or weight with unit): 50 µL distilled water

POSITIVE CONTROL SUBSTANCE
- Amount(s) applied (volume or weight with unit): 50 µL potassium hydroxide, 8N

Duration of treatment / exposure:

3 min and 1 h

Observation period:

Not applicable. Post-treatment incubation period 3 h.

Number of animals:

Not applicable. The test was performed in duplicate tissues for each treatment and control group.

Details on study design:

TEST SITE
- Area of exposure: 0.6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: Example: the test item was washed with saline solution from the skin surface.
- Time after start of exposure: 3 and 60 min
- Post-treatment incubation period: 3 h
CELL VIABILITY MEASUREMENTS:
For determining alterations in cell viability, MTT reduction assays were performed 3 h after the incubation period. Therefore, tissues were incubated in MTT solution for 3 h at 37 ± 1 °C and 5% CO2. After elimination of the MTT solution, tissues were washed 3 times in PBS.. After removing the tissue obtained dye solution was homogenized and transferred in triplicate aliquots of 200 µL to 96-well plate. The optical density was measured at 570 nm wave length in a plate spectrophotometer.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min

Value:

27

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 min

Value:

6

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Based on the available data the substance has to be considered as corrosive under the conditions of the test.

Any other information on results incl. tables

Table 1: MTT assay after 3 min exposure

	Negative control		Positive control		Test item
Tissue sample	1	2	1	2	1	2
OD570	2.007 1.993 2.010	2.067 2.032 2.074	0.545 0.527 0.533	0.438 0.431 0.436	0.485 0.472 0.475	0.650 0.626 0.629
OD570(mean)	2.003	2.058	0.535	0.435	0.477	0.635
OD570(mean values of replicates)	2.031		0.485		0.556
Viability (%)	100		24		27

Table 2: MTT assay after 60 min exposure

	Negative control		Positive control		Test item
Tissue sample	1	2	1	2	1	2
OD570	1.841 1.848 1.853	1.687 1.640 1.658	0.168 0.163 0.191	0.251 0.250 0.252	0.091 0.093 0.086	0.119 0.117 0.116
OD570(mean)	1.847	1.662	0.174	0.251	0.090	0.117
OD570(mean values of replicates)	1.755		0.213		0.104
Viability (%)	100		12		6

Applicant's summary and conclusion

Interpretation of results:

other: Skin corr. 1, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).