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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | 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
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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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-fluoro-4-methyl-1,3,2-dioxaphospholane
- Cas Number:
- 16415-09-1
- Molecular formula:
- C3H6FO2P
- IUPAC Name:
- 2-fluoro-4-methyl-1,3,2-dioxaphospholane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- Salmonella typhimurium(S. typhimurium) strains(TA98, TA100, TA1535 and TA1537) and tryptophan requiring Escherichia coli(E. coli) strain(WP2 uvrA(pKM101))
- Metabolic activation:
- with and without
- Metabolic activation system:
- [S9 fraction]
Species : Rat
Sex : Male
Strain : Sprague-Dawley
Supplier : Molecular Toxicology, Inc.
Storage condition : Freeze(-15 °C below)
Product No. : 11-01L
Lot No. : 4365
Inductive material : Aroclor 1254-induced rat liver S-9
[S9 cofactor]
Name : Cofactor Ⅰ
Manufacturer : Genogen Co., Ltd.
Lot No. : 201215-I, 210203-I
Storage condition : Deep freeze(-70±20 °C) - Test concentrations with justification for top dose:
- Dose levels: 6.9, 20.6, 61.7, 185.2, 555.6, 1666.7 and 5000 μg/plate
In result of dose range finding study, turbidity and precipitation of test substance were not observed at all dose in the all strains in the treatment mixture. Also, when revertants were counted at the end of the incubation period, precipitation was not observed at all dose in the all strains. There was no cytotoxicity or increases in mean number of revertants at all dose in the all strains both in the presence and absence of the metabolic activation system.
In the positive control group, increases of mean number of revertant was observed more than twice compared to the negative control group.
According to results of dose range finding study, the highest dose in the main study was selected as 5000 μg/plate and serially diluted to consist of five dose levels(61.7, 185.2, 555.6, 1666.7 and 5000 μg/plate) by the common ratio of 3. - Vehicle / solvent:
- Dimethyl sulfoxide(DMSO)
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide(DMSO)
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: N-Methyl-N’-nitro-N-nitrosoguanidine
- Evaluation criteria:
- If the test substance meets the following criteria, it was judged as negative.
- When there is no dose-dependent increase of mean number of revertants in the test substance-treated group and mean number of revertants is less than 2 times the number of negative control group.
If the test substance meets all the following criteria, it was judged to be positive.
Regardless of the application of the metabolic activation system to the test substance exposure, the test substance was judged to induce a reverse mutation in the bacteria strains when the following results are obtained in at least one strain. At this time, biological relevance was considered.
- When there is dose-dependent increase of mean number of revertants in the test substance-treated group.
- When mean number of revertants in the test substance-treated group is 2 times or more than the number of revertants in negative control group at one or more dose.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- All validity criteria of this test were fulfilled. No increases in mean number of revertants were observed at all dose in the all strains both in the presence and absence of the metabolic activation system compared to the negative control group.
In conclusion, the test substance, FCCA-04, was considered as not having reverse mutagenic potential on bacterial strains under the present study 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.
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