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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: well documented guideline study

Data source

Reference
Reference Type:
publication
Title:
Toxicology studies with N-acetyl-L-serine.
Author:
van de Mortel EL, Shen ZA, Barnett JF Jr, Krsmanovic L, Myhre A, Delaney BF.
Year:
2010
Bibliographic source:
Food Chem Toxicol. 2010 Aug-Sep;48(8-9):2193-9

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
L-serine
EC Number:
200-274-3
EC Name:
L-serine
Cas Number:
56-45-1
Molecular formula:
C3H7NO3
IUPAC Name:
L-serine

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9
Test concentrations with justification for top dose:
0 µg/plate, 333 µg/plate, 667 µg/plate, 1000 µg/plate, 3333 µg/plate, 5000 µg/plate
Vehicle / solvent:
water
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Remarks:
for TA98 with S9
Positive control substance:
benzo(a)pyrene
Positive controls:
yes
Remarks:
for TA98 without S9
Positive control substance:
2-nitrofluorene
Positive controls:
yes
Remarks:
for TA100 and TA1535 without S9
Positive control substance:
sodium azide
Positive controls:
yes
Remarks:
for WP2uvrA without S9
Positive control substance:
4-nitroquinoline-N-oxide
Positive controls:
yes
Remarks:
for TA1537 without S9
Positive control substance:
other: Acridine mutagene
Positive controls:
yes
Remarks:
for TA100, TA1535, TA1537, and WP2uvrA with S9
Positive control substance:
other: 2-Aminoanthracene
Evaluation criteria:
Test were considered valid if the mean number of revertants for the negative control of each tester strain were within the acceptable range of spontaneous revertants and if the number of revertants in the positive control was at least 3-fold higher than the respective negative control.

Results and discussion

Test resultsopen allclose all
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:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance showed no mutagenic potency in the reverse gene mutation assay in bacteria.
Executive summary:

In a reverse gene mutation assay in bacteria, strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium and WP2uvrA of E. coli were exposed to the test substance at concentrations of 33.3, 66.7, 100, 333, 667, 1000, 3333, and 5000 µg/plate in the presence and absence of mammalian metabolic activation.   

There was no evidence of induced mutant colonies over background.