L-serine

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: 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

Test material information

Constituent 1

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 / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

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

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

water

Positive controls:

yes

Remarks:

for TA98 with S9

Positive control substance:

benzo(a)pyrene

Controls 2

Positive controls:

yes

Remarks:

for TA98 without S9

Positive control substance:

2-nitrofluorene

Controls 3

Positive controls:

yes

Remarks:

for TA100 and TA1535 without S9

Positive control substance:

sodium azide

Controls 4

Positive controls:

yes

Remarks:

for WP2uvrA without S9

Positive control substance:

4-nitroquinoline-N-oxide

Controls 5

Positive controls:

yes

Remarks:

for TA1537 without S9

Positive control substance:

other: Acridine mutagene

Controls 6

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 results

Test results 1

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

Test results 2

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.