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EC number: 605-263-0 | CAS number: 161611-74-1
- 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:
- 02-Dec-15 to 07-Mar-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Except for the quality environment in which the characterisation of the test item was performed was not known.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 605-263-0
- EC Number:
- 605-263-0
- Cas Number:
- 161611-74-1
- Molecular formula:
- C4F6O3
- IUPAC Name:
- 605-263-0
- Test material form:
- liquid
- Details on test material:
- - Physical state: Colourless liquid; odorless
- Storage condition of test material: At room temperature
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
Species / strain
- Species / strain / cell type:
- other: S. Typhimurium (TA98, TA100, TA102, TA1535 and TA1537)
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary test (without and with S9) TA100: 200, 500, 1000, 2000 and 5000 µg/plate
Main study:
- Experiment 1 (pre incubation): TA1535, TA1537, TA102 and TA98: Without and with S9-mix: 200, 500, 1000, 2000 and 5000 µg/plate
- Experiment 2 (pre incubation): TA1535, TA1537, TA98, TA100 and TA102: Without and with S9-mix: 200, 500, 1000, 2000 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran
- Justification for choice of solvent/vehicle:
Test compound was soluble in tetrahydrofuran and tetrahydrofuran has been accepted and approved by authorities and international guidelines.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9: 650 µg/plate in DMSO for TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9: 10 µg/plate in DMSO for TA98 and 15 µg/plate for TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Tert-butyl hydroperoxide (TBH)
- Remarks:
- without S9: 250 µg/plate in DMSO for TA102
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9: 5 µg/plate in saline for TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene in DMSO for all tester strains
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre incubation
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined.
ACCEPTABILITY OF THE ASSAY:
A Salmonella typhimurium reverse mutation assay and/or Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
a) The vehicle control and positive control plates from each tester strain (with or without S9-mix) must exhibit a characteristic number of revertant colonies when compared against relevant historical control data generated at WIL Research Europe.
b) The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
c) No more than 5% of the plates are lost through contamination or some other unforeseen event. If the results are considered invalid due to contamination, the experiment will be repeated. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or TA102 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or 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 if:
a) The total number of revertants in the tester strains TA100 and TA102 is greater than two (2) times the concurrent control, or the total number of revertants in the tester strains TA1535, TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a follow up experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- No toxicity or mutagenicity was observed up to and including the top dose of 5000 µg/plate
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.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- No toxicity or mutagenicity was observed up to and including the top dose of 5000 µg/plate - Remarks on result:
- other: not mutagenic
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, test substance is not considered as mutagenic with and without metabolic activation in S. typhimurium strains TA1535, TA1537, TA98, TA100 and TA102.
- Executive summary:
In a reverse gene mutation assay performed according to the OECD test guideline No. 471, EU Method B.13/14 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98 TA100 and TA 102) were exposed to the test substance diluted in tetrahydrofuran at the following concentrations both in the presence and absence of metabolic activation system (S9 -mix).
Preliminary test (without and with S9) TA100: 200, 500, 1000, 2000 and 5000 µg/plate
Main study:
- Experiment 1 (pre incubation): TA1535, TA1537, TA102 and TA98: Without and with S9-mix: 200, 500, 1000, 2000 and 5000 µg/plate
- Experiment 2 (pre incubation): TA1535, TA1537, TA98, TA100 and TA102: Without and with S9-mix: 200, 500, 1000, 2000 and 5000 µg/plate
Negative and positive control groups were also included in mutagenicity tests.
The negative control values were within the laboratory historical control data ranges, except the responses for TA102 (absence of S9-mix, first experiment) and TA1535 (absence of S9-mix, second experiment). However since the mean number of revertant colonies showed a characteristic number of revertant colonies (237 and 3 revertant colonies, respectively) when compared against relevant historical control data (248 and 5 relevant colonies, respectively), the validity of the test was considered to be not affected.
The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly, except the response for TA1535, TA1537 and TA98 in the second experiment. The purpose of the positive control is as a reference for the test system, where a positive response is required to check if the test system functions correctly. Since the value was more than 3 times greater than the concurrent solvent control values, this deviation in the mean plate count of the positive control had no effect on the results of the study.
No cytotoxic effect was observed. 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.
Under the test conditions, test substance is not considered as mutagenic with and without metabolic activation in S. typhimurium strains TA1535, TA1537, TA98, TA100 and TA102.
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
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