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EC number: 700-857-7 | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 14 to July 5, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD guideline 471 without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-hydroxy-4-(methylthio)butyric acid
- EC Number:
- 209-523-0
- EC Name:
- 2-hydroxy-4-(methylthio)butyric acid
- Cas Number:
- 583-91-5
- Molecular formula:
- C5H10O3S
- IUPAC Name:
- 2-hydroxy-4-(methylthio)butanoic acid
- Details on test material:
- - Name of test material (as cited in study report): HMTBA (Rhodimet AT88), 2-Hydroxy-4-methylthiobutanoic acid
- Physical state: brown viscous liquid
- Analytical purity: 89.8%
- Impurities (identity and concentrations): water content: 9.1%, ammonium sulfate: 1.5%
- Purity test date: 22 March 2010
- Lot/batch No.: 7809307
- Date received: 23 March 2010
- Expiration date of the lot/batch: 03 November 2010
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- Not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver post-mitochondrial fraction (S-9), obtained from Molecular Toxicology Incorporated, USA
- Test concentrations with justification for top dose:
- - Range-finder experiment: 10, 100, 500, 1000, 2500 and 5000 µg/plate (with and without S-9) in TA 98, TA 100 and TA 102 strains;
- Experiments 1 and 2: 312.5, 625, 1250, 2500 and 5000 µg/plate (with and without S-9)
All the concentrations and dose-levels were expressed as active item, taking into account the purity of the test item (89.8%). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulphoxide (DMSO)
- Justification for choice of solvent/vehicle: The test item was freely soluble in the vehicle (DMSO) at 100 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See table 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plate incorporation method; as the results of Experiment 1 were negative, treatments in the presence of S-9 in experiment 2 included a pre-incubation step (incubation for 1 hour at 37°C).
DURATION
After plating, the plates were inverted and incubated at 37°C in the dark for 48 to 72 h.
SELECTION AGENT (mutation assays): histidine
NUMBER OF REPLICATIONS:
Range-finding test: single plate
Main experiments: triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertant colonies and/or a thinning of the bacterial lawn. - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
- Statistics:
- None
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- - Range-finder experiment: No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels. No noteworthy toxicity was noted towards the three strains used, either with or without S9 mix.
Since the test item was freely soluble and non-toxic, the highest selected dose-level was 5000 µg/plate.
- Experiments 1 and 2: No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels. No noteworthy toxicity was noted towards all the strains used, either with or without S9 mix.
Slight increases in the number of revertants exceeding the threshold of 2-fold the vehicle control value (up to 2.5-fold) were induced in the TA 98 strain in the first experiment without S9 mix. Since these increases were neither dose-related, nor reproducible (not observed in the second experiment), they were considered as non-biologically relevant. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the test conditions, HMTBA (Rhodimet AT88) is not considered as mutagenic in this bacterial system according to the criteria of the Annex VI to the Directive 67/548/EEC and CLP Regulation(EC) N° (1272-2008). - Executive summary:
- In a GLP study performed according to OECD guideline 471, HMTBA (Rhodimet AT88) was tested for mutagenicity using Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 with the plate incorporation and preincubation methods in the presence and absence of metabolic activation system (S-9 mix). In range-finder test, using TA98, TA100 and TA102 tested at concentrations between 10 and 5000 µg/plate with and without S-9, the test item was freely soluble and non-toxic; therefore the selected treatment-levels were: 312.5, 625, 1250, 2500 and 5000 µg/plate for both mutagenicity experiments with and without S9 mix. The positive controls induced the appropriate responses in the corresponding strains. HMTBA (Rhodimet AT88) showed no substantial increases in revertant colony numbers over control count obtained with any of the tester strains at any concentrations in either presence or absence of S-9. Under the test conditions, HMTBA (Rhodimet AT88) is not considered as mutagenic in this bacterial system according to the criteria of the Annex VI to the Directive 67/548/EEC and CLP Regulation(EC) N° (1272-2008).
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