Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 206-229-4 | CAS number: 312-84-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
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:
- 2 004
- 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
- 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
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.