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EC number: 252-106-3 | CAS number: 34592-47-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (R)-thiazolidine-4-carboxylic acid
- EC Number:
- 252-106-3
- EC Name:
- (R)-thiazolidine-4-carboxylic acid
- Cas Number:
- 34592-47-7
- Molecular formula:
- C4H7NO2S
- IUPAC Name:
- (R)-thiazolidine-4-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- histidine
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 fraction
- Test concentrations with justification for top dose:
- On the basis of the results obtained in the preliminary toxicity test, in Main Assay I, using
the plate incorporation method, the test item was assayed with all tester strains at the
following dose levels: 5000, 2500, 1250, 625 and 313 µg/plate.
- Details on test system and experimental conditions:
- A preliminary toxicity test was undertaken in order to select the concentrations of the test
item to be used in the Main Assays. In this test a wide range of dose levels of the test item,
set at half-log intervals, were used. Treatments were performed both in the absence and
presence of S9 metabolism using the plate incorporation method; a single plate was used
at each test point and positive controls were not included. Toxicity was assessed on the
basis of a decline in the number of spontaneous revertants, a thinning of the background
lawn or a microcolony formation.
Two Main Assays were performed including negative and positive controls in the absence
and presence of an S9 metabolising system. Three replicate plates were used at each test
point.
In addition, plates were prepared to check the sterility of the test item suspensions and
the S9 mix and dilutions of the bacterial cultures were plated on nutrient agar plates to
establish the number of bacteria in the cultures.
The Main Assay I was performed using a plate-incorporation method. The components
of the assay (the tester strain bacteria, the test item and S9 mix or phosphate buffer) were
added to molten overlay agar and vortexed. The mixture was then poured onto the surface
of a minimal medium agar plate and allowed to solidify prior to incubation.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Additional information on results:
- No toxicity was observed at any dose level with any tester strain, in the absence or presence
of S9 metabolic activation.
As no relevant increase in revertant numbers was observed at any concentration tested, a
Main Assay II was performed using the same concentrations and including a pre-incubation
step for all treatments. No toxicity or relevant increase in the number of revertant colonies
was observed in the pre-incubation assay, at any dose level, with any tester strain/treatment
condition combinations.
No precipitation of the test item was observed in any experiment, at any dose level, in the
absence or presence of S9 metabolic activation.
The test item did not induce two-fold increases in the number of revertant colonies in the
plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the
absence or presence of S9 metabolism.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the test item L(-)-Thiazolidine-4-carboxylic acid (TCA) does not induce
reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence
of S9 metabolism, under the reported experimental conditions.
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