Sodium sarcosinate

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)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD test guideline 431

Principles of method if other than guideline:

The present test is based on the experience that corrosive chemicals produce cytotoxicity in human reconstructed epidermis after a short term topical exposure. The test is designed to predict skin corrosion potential of a chemical by using the three dimensional human epidermis model EpiDermTM. After application of the test material to the stratum corneum surface of the EpiDermTM tissue for 3 minutes and 1 hour the induced cytotoxicity (=loss of viability) is measured by a colorimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5- dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan. After isopropanol extraction of the formazan from the tissue the optical density of the extract is determined spectrophotometrically. Optical density of the extracts of test substance treated tissues is compared to negative control values from tissue treated with doubly distilled water and expressed as relative tissue viability.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium sarcosinate

EC Number:

224-338-5

EC Name:

Sodium sarcosinate

Cas Number:

4316-73-8

Molecular formula:

C3H6NNaO2

IUPAC Name:

sodium (methylamino)acetate

Test animals

Species:

other: EpiDerm Corrosivity-Test in vitro

Test system

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

3 min, 1 h

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min

Value:

ca. 71

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

ca. 16

Any other information on results incl. tables

	Exposure: 3 min
Test-Article	OD570 tissue 1	OD570 Tissue 2	OD570 Killed tissue control	mean OD570	mean OD570 killed tissue control corrected	Viability [% of negative control]
Negative Control	1.877	2.001	0.219	1.939	-	100
Sarcosine-Na solution	1.741	0.996	0.233	1.369	-	71
Positive Control	0.463	0.397		0.430	-	22
	Exposure: 1 h
Test-Article	OD570 tissue 1	OD570 Tissue 2	OD570 Killed tissue control	mean OD570	mean OD570 killed tissue control corrected	Viability [% of negative control]
Negative Control	1.879	1.895	0.221	1.887	-	100
Sarkosine-Na solution	0.285	0.306	0.266	0.296	-	16
Positive Control	0.143	0.341	-	0.242	-	13