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EC number: 700-330-1 | CAS number: 433733-92-7
- 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
- Study period:
- 06 May - 05 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2S,3S,3aR,9aS)-3-hydroxy-2-(hydroxymethyl)-7-methyl-2,3,3a,9a-tertryhydro-6H-furo[2’,3’:4,5][1,3]oxazolo [3,2-a]pyrimidin-6-one
- EC Number:
- 700-330-1
- Cas Number:
- 433733-92-7
- Molecular formula:
- C10H12N2O5
- IUPAC Name:
- (2S,3S,3aR,9aS)-3-hydroxy-2-(hydroxymethyl)-7-methyl-2,3,3a,9a-tertryhydro-6H-furo[2’,3’:4,5][1,3]oxazolo [3,2-a]pyrimidin-6-one
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material (as cited in study report): Anhydrothymidine
- Substance type: White powder
- Physical state: powder
- Analytical purity: 99.7%
- Purity test date: not stated
- Lot/batch No.: 073904/05
- Expiration date of the lot/batch: 11 December 2008
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Method
- Target gene:
- histidine gene in Salmonella typhimurium
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 97, TA 98, TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Dose range finding test: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix for TA100
First assay: 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix for TA1535, TA97, TA98 and TA102
Second assay: 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix for TA1535, TA97, TA98, TA100 and TA102 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulfoxide
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- dimethyl sulfoxide
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation (-S9-mix) Migrated to IUCLID6: 5 μg/plate in saline for TA1535
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191 1 μg/plate in DMSO for TA97
- Remarks:
- Without metabolic activation (-S9-mix)
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without metabolic activation (-S9-mix) Migrated to IUCLID6: 10 μg/plate in DMSO for TA98
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation (-S9-mix) Migrated to IUCLID6: 650 μg/plate in DMSO for TA100
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- Without metabolic activation (-S9-mix) Migrated to IUCLID6: 0.1 µg in DMSO for TA102
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene in DMSO (5 and/or 10%) for all tester strains
- Remarks:
- With metabolic activation (-S9-mix) for all tested strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
DETERMINATION OF CYTOTOXICITY
- Method: reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies
OTHER EXAMINATIONS:
- Determination of precipitation - Rationale for test conditions:
- Selection of an adequate range of doses was based on a dose range finding test with tester strain
TA100 with and without S9-mix. Eight concentrations, 3, 10, 33,100,333, 1000, 3330 and
5000 μg/plate were tested in triplicate. This dose range finding test was reported as a part of the
first experiment of the mutation assay. The highest concentration of Anhydrothymidine used in
the subsequent mutation assay was 5 mg/plate. - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in the tester strain TA100, TA97 and TA102 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, and TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100, TA97 and TA102 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535 and, TA98 is greater than three (3) times the concurrent control.
b) In case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 97, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: no increase in the number of revertants was observed upon treatment with Anhydrothymidine under all conditions tested.
COMPARISON WITH HISTORICAL CONTROL DATA: The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Any other information on results incl. tables
Precipitate
Precipitation of Anhydrothymidine on the plates was not observed at the start or at the end of the incubation period.
Toxicity
In both mutation assays, there was no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in all tester strains in the absence and presence of S9-mix.
Mutagenicity
In both mutation assays, no increase in the number of revertants was observed upon treatment with Anhydrothymidine under all conditions tested.
Applicant's summary and conclusion
- Conclusions:
- All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.
The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
It is concluded that the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
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