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EC number: 206-406-6 | CAS number: 335-99-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames Test (OECD TG 471): negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: The Japanese Ministry of Economy Trade and Industry (METI), Ministery of Health, Labour and Welfare (MHLW) and Ministry of the Environment (MOE) Guidelines
- Version / remarks:
- March 2011
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- mutant histidine gene and mutant tryptophan gene
- 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:
- Phenobarbital/β-naphthoflavone induced rat liver S9 were used as the metabolic activation system. The S9 was prepared and stored according to the currently valid version of the SOP for rat liver S9 preparation. Each batch of S9 was routinely tested for its capability to activate the known mutagens benzo[a]pyrene and 2-aminoanthracene in the Ames test.
The protein concentration of the S9 preparation was 32.0 mg/mL (Lot. No.: 140520B) in all experiments. The S9 mix comprised 10% S9 fraction. - Test concentrations with justification for top dose:
- In the pre-experiment the concentration range of the test item was 3 – 5000 μg/plate. The pre-experiment is reported as experiment I. Depending on the toxic effects, observed in experiment I, seven, respectively six concentrations were tested in experiment II. 5000 μg/plate were chosen as maximal concentration in experiment II. The concentration range included two logarithmic decades.
The following concentrations were tested in experiment II:
Strains TA 1535, TA 98 and TA 100: 10; 33; 100; 333; 1000; 2500 and 5000 μg/plate
Strains TA 1537and WP2 uvrA: 33; 100; 333; 1000; 2500; and 5000 μg/plate
Since the acceptance criterium of at least five analysable concentration was only just reached in strain TA 98 in the presence of S9 mix, this part of experiment II was repeated in this strain. It is reported as experiment IIa. The maximum concentration in experiment IIa was 1000 μg/plate. The following concentrations were tested in experiment IIa:
1; 3; 10; 33; 100; 333; and 1000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:
On the day of the experiment, the test item 1H,1H,7H-perfluoroheptane-1-ol was dissolved in DMSO (purity > 99%). The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria (Maron et al.; 1981).
All formulations were prepared freshly before treatment and used within two hours of preparation. The formulation was proven to be stable for this period in a separate GLP study (Currenta File No.: 2018/0047/08) conducted at CURRENTA GmbH & Co. OHG. - Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-Aminoanthracene for TA 100, TA 1535, TA 1537, TA 98, and WP2 uvrA (+ S9) (2.5 µg/plate) 4-nitro-o-phenylene-diamine for TA1537 (50 µg/plate, -S9) and TA 98 (10 µg/plate, -S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation and pre-incubation
DURATION
- Preincubation period: 60 min at 37 °C ± 1.5 °C
- Exposure duration: at least 48 hours at 37 °C ± 1.5 °C in the dark
NUMBER OF REPLICATIONS: all plates were prepared in triplicate
DETERMINATION OF BACTERIOTOXICITY
- Method: gross appraisal of background growth
ACCEPTABILITY OF THE ASSAY:
The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
• regular background growth in the negative and solvent control;
• the spontaneous reversion rates in the negative and solvent control are in the range of our historical data;
• the positive control substances should produce an increase above the threshold of twofold (strains TA 98, TA 100, and WP2 uvrA) or threefold (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control;
• a minimum of five analysable dose levels should be present with at least three dose levels showing no signs of toxic effects, evident as a reduction in the number of revertants below the indication factor of 0.5. - Evaluation criteria:
- test item is considered as a mutagen if a biologically relevant increase in the number of revertants of twofold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) the spontaneous mutation rate of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is reached or exceeded at more than one concentration.
An increase of revertant colonies equal or above the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory. Evaluation based on criteria mentioned above
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate in experiment II only
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at >= 2500 µg/plate without S9 and at >=1000 µg/plate with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at >= 1000 µg/mL with and without S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at >= 2500 µg/mL without S9 and >= 1000 µg/mL with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate without S9 mix in Exp. II only
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
- Executive summary:
The test item was evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and Escherichia coli WP2 uvrA, performed according to OECD TG 471. Doses of up to and including 5000 µg per plate were tested in experiment I and II. Based on the observed toxic effects, evident as a redution in the number of revertants (below the indication factor of 0.5), 1000 µg/plate were chosen as maximum concentration in experiment IIa.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
The test material was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The OECD Toolbox (v. 4.3.1) revealed several alerts for mutagenicity of the substance. The Toolbox results for mutagenicity are based on haloalkanes with iodine, bromine and/or chlorine. Such haloalkanes have a much higher reactivity towards SN2 reactions than fluorated haloalkanes. Therefore, the results given by the Toolbox are considered to be not relevant for the registered fluorated substance.
The test item was evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and Escherichia coli WP2 uvrA, performed according to OECD TG 471. Doses of up to and including 5000 µg per plate were tested in experiment I and II. Based on the observed toxic effects, evident as a redution in the number of revertants (below the indication factor of 0.5), 1000 µg/plate were chosen as maximum concentration in experiment IIa.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
The test material was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
Justification for classification or non-classification
Based on an Ames Test performed according to OECD TG 471 with negative outcome, no classification is warranted for mutagenicity.
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