Sodium sarcosinate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study with acceptable restrictions (Missing strain for crosslinking/oxidizing agents)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

4 strains only; Missing strain for crosslinking/oxidizing agents

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

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:

C3H7NO2.Na

IUPAC Name:

sodium (methylamino)acetate

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S-9 mix

Test concentrations with justification for top dose:

0, 100, 500, 2500, 5000 and 10000 µg/plate

Vehicle / solvent:

Solvent used: aqua dest.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: + S-9 mix: 2-aminoanthracene; - S-9 mix: methyl-N'-nitro-N-nitrosoguanidine for TA 100 and TA 1535; 4-nitro-o-phenylendiamine for TA98; 9-aminoacridine chloride monohydrate for TA 1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation

DURATION
- Preincubation period: 20 min
- Expression time (cells in growth medium): 48 h

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: A bacteriotoxic effect was observed at doses > 5000 µg/plate in the SPT only using TA 100 and TA 1537 and in the PIT with all tester strains

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

		STANDARD PLATE TESTS		PREINCUBATION TEST
strain	S9 mix	Revertants in Veh. Control	Max Revertants (dose µg/plate)	Revertants in Veh. Control	Max Revertants (dose µg/plate)
T98	-	18	23 (100; 500)	28	25 (2500)
	+	32	31(100)	27	31 (100)
T100	-	124	127 (500)	100	112 (500; 2500)
	+	144	160 (500)	5	16 (100)
T1535	-	19	24 (5000)	16	13 (100; 500)
	+	22	34 (100)	13	14 (100)
T1537	-	8	11 (100)	8	7 (100; 500; 5000)
	+	10	13 (100, 5000)	2	2 (5000; 10000)