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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 November 2004 - 13 December 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: "Standard for Investigation by Mutagenicity Studies using Microorganisms" of Notification No.77 of Ministry of Labor, 1988
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: "Stardard Concerning Testing Laboratories Implementing Tests for New Chemical Substances etc."
Version / remarks:
Pharmaceutical and Food Safety Bureau Notification No. 1121003, Manufacturing Industries Bureau Notification No.3 November 17, 2003 and Environmental Policy Bureau Notification No. 031121004, November 21, 2003.
Deviations:
no
Principles of method if other than guideline:
Conditions:
- Test substance + bacterial culture + Sodim phosphate buffer
- Test substance + bacterial culture + S9 mix
- Negative control
- Positive control
Parameters observed:
- Bacterial growth inhibition
- precipitation of the test substance
- number of revertant colonies
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
D-serine
EC Number:
206-229-4
EC Name:
D-serine
Cas Number:
312-84-5
Molecular formula:
C3H7NO3
IUPAC Name:
D-serine
Test material form:
solid
Details on test material:
- Appearance: white solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: K0498003
- Purity: 100%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Water; soluble (stable, unhydrolysis)

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: prepared and stored at 25°C for maximum 2 hours and 10 minutes just before use

Method

Target gene:
Histidine
Tryptophan
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:
S9 mix
Test concentrations with justification for top dose:
Strains Without S9 mix With S9 mix
Highest dose Common ratio Dose levels Highest dose Common ratio Dose levels
TA100 5000µg/plate 2 5 5000µg/plate 2 5
TA1535 5000µg/plate 2 5 5000µg/plate 2 5
WP2 uvrA 5000µg/plate 2 5 5000µg/plate 2 5
TA98 5000µg/plate 2 5 5000µg/plate 2 5
TA1537 5000µg/plate 2 5 5000µg/plate 2 5
Vehicle / solvent:
Solvent: distilled water
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
Remarks:
witout S9 mix:TA100, TA98, WP2 uvrA
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA1535 witout S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 6-Chloro-9-[3-(2-chloroethylamino)-propylamino]-2-methoxyacridine
Remarks:
TA1537 without S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
all strains with S9 mix
Details on test system and experimental conditions:
Incubation temperature: 37°C.
Incubation duration: 48 hours.
Evaluation criteria:
When the number of revertant colony is increases 2-fold or more by the test substance treaments compared too the negative control and its dose dependency and the reproducibility are observed, it is considered as positive. Other cases than the above, it is considered as negative.
Statistics:
No statistical analysis is performed for data analysis.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
other: not within acceptable range
Positive controls validity:
valid
Additional information on results:
A retest was onducted in TA1535 with and without S9 mix. The number of revertant colonies both with and without metabolic activation in all of the strains was less than 2-fold compared to that of the negative control.

Applicant's summary and conclusion

Conclusions:
It was concluded that the test substance is not mutagenic under the test conditions.
Executive summary:

The mutagenicity of the test material was assessed in a study which was conducted under GLP conditions and following a method similar to OECD 471 and using the bacterial strains Salmonella typhimurium TA100, TA1531, TA98 and TA1537 as well as Escherichia coli WP2 uvrA.

In a dose range finding study, the highest doses were set at 5000 µg/plate. Seven doses were investigated with a common ratio of 4. In the main test for all strains, the highest doses were set at 5000 µg/plate, and 5 doses were set with a common ratio of 2.

The number of revertant colonies both with and without metabolic activation in all strains tested was less than 2 -fold compared with that of the negative control. At the same time, the positive controls induced revertant colonies by 2 -fold or more of the negative control value in each strain, indicating the validity of the test.

It was therefore concluded that the test substance is not mutagenic under the test conditions.