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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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

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)

Applicant's summary and conclusion