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EC number: 252-043-1 | CAS number: 34454-97-2
- 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:
- 16 October 2001 to 09 Novermber 2001 (dates of study plan)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2001
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:
- other: European Economic Community Directive 67/548/EEC, Part B.
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- T-7599
- IUPAC Name:
- T-7599
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): T-7599
- Substance type: Mono-constituent substance
- Physical state: Solid
- Analytical purity: >99.9% 1-Butanesulfonamide,1,1,2,2,3,3,4,4,4-Nonafluoro-n-(2-Hydroxyethyl)-N-Methyl-; < 0.1% Methylamine
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 07 August 2002
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-fraction
- Test concentrations with justification for top dose:
- The test article was tested at concentrations of 3, 10, 33, 100, 333, 1000, 3330, and 5000 ug/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Saline and DMSO
- Justification for choice of solvent/vehicle: Physiological saline used for TA1535, TA1537 and TA98 strains without metabolic activation. DMSO was used as a solvent for the remaining strains. DMSO was used as a negative control because it was used as a vehicle.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Number of spontaneous revertants per plate
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: W/o S9: TA 1535- sodiumm azide; TA 1537- 9-aminoacridine ; TA98- daunomycine; TA100- methylmethanesulfonate; WP2uvrA- 4-nitroquinoline N-oxide. W S9: TA 1537, TA 1535, TA98, TA100, WP2uvrA- 2-aminoanthracene.
- Details on test system and experimental conditions:
- Each tester strain had the following additional mutations: Defective lipopolysaccharide cellcoat, mutation in the galactose metabolism; mutation in nitrate reductase; defective biotin synthesis, loss of the excision repair system-deletion of the ultraviolet-repair B gene.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours
OTHER EXAMINATIONS:
- Other: Colony counting - Evaluation criteria:
- The test substance is considered negative in the test if the total number of revertants in any tester strain at any concentration is less than two times the solvent control value. The negative response should be reproducible in at least one independently repeated experiment. A test substance is considered positive if it induces a number of revertant colonies greater than two-times the number of revertants induced by the solvent control in any of the tester strains with or without metabolic activation. The positive response should be reproducible in at least one independently repeated experiment.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test article was cyctotoxic at 5000 ug/plate in TA 1535 and TA1537 without S9 mix and in the same strains at 3300 and 5000 ug/plate with S9 mix.
- Vehicle controls validity:
- other: The vehicle for the test article (DMSO) was used as a negative control.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance did not precipitate in the top agar. Precipitation of the test article o the plates was not observed at the start or at the end of the incubation period in tester strain TA100 and WP2uvrA.
RANGE-FINDING/SCREENING STUDIES: The test article was tested in strains TA 100 and Wp2urA with concentrations of 3, 10, 33, 200, 333, 1000, 3330 and 5000 micrograms per plate in the absence and presence of 5% (v/v) S9-mix. The test article did not precipitate in the top agar and was not observed at the start or at the end of the incubation period in tester strains. No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants was observed. No increase in the number of revertants was observed upton treatment with T-7599 under all conditions tested. The highest concetration of the test article used in the subsequent mutation assay was the recommended 5 mg/plate or thelevel at which the test substance inhibited baceterial growth.
COMPARISON WITH HISTORICAL CONTROL DATA: The reverse mutation assays are considered acceptable if the negative control data should be within the laboratory background hisorical range for each tester strain, the positive control chemcials should produce responses in all tester strains which are within the laboratory historical range documented for each positive control substance and 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 6 mg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
All bacterial strains showed negative responses over the entire dose range (no dose-related, two-fold, increase in the number of reverants in two independently repeated experiments). The negative and strain-specific positive control values were within the laboratoy background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of the study, it is concluded that the test article is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
The test article was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (IA1535, TA1537, TA100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli WP2uvrA. The test was performed in two independent experiments in the presence and absence of S9-mix. In the dose range finding test, the test article was tested up to concentrations of 5000 and 4740 micrograms/plate in the strains TA100 and WP2uvrA, respectively in the absence and presence of 5% (v/v) S9-mix. The test article did not precipitate on the plates at this dose level. In tester strain TA100, toxicity was observed at dose levels of 3330 and 5000 micrograms/plate in the absence of S9-mix and at a dose level of 1000 micrograms/plate and upwards already in the presence of S9-mix. In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested. In the first mutation assay, the test article was tested up to concentrations of 5000 micrograms/plate in the absence and presence of 5% (v/v) S9-mix in the strains TA1535, TA1537 and TA98. Toxicity was observed in all three tester strains. In the second mutation assay, the test article was tested up to concentrations of 3330 micrograms/plate in tester strain TA1535, TA1537 and TA100 and up to 5000 micrograms/plate in tester strain TA98 and WP2uvrA in the absence and presence of 10% (v/v) S(-mix. Toxicity was observed in all tester strains, except in test strain WP2uvrA in the presence of S9-mix. The test article did not induce a dose-related, two-fold increase in the number of revertant (His+) colonies in each of the four tester strains and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Based on the results of this study, it is concluded that the test article is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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