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Diss Factsheets
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EC number: 206-557-8 | CAS number: 354-33-6
- 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
Description of key information
Subacute and subchronic inhalation studies in rats
Key value for chemical safety assessment
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 245 440 mg/m³
Additional information
Groups of 10 male and 10 female Sprague Dawley rats were exposed to 0, 5000, 15000 and 50000 ppm (0, 24544, 73632 and 245440 mg/m3) HFC 125 for 28 days (6 hours/day, 5 days/week). Two additional groups were exposed to 0 and 50,000 ppm HFC-125 and were allowed to recover for two weeks after the exposure period (Nakayama et al., 1992).
No mortality was observed in this study. There were no treatment-related clinical signs of toxicity and differences in body weight and food consumption among the treated and the control groups, neither after the exposure nor after the recovery period. Some effects were observed in the haematology and blood chemistry analysis.
Neither macroscopic nor microscopic changes were observed during gross pathology and histological examinations, respectively. Study of peroxisomal proliferation gave equivocal results, since a slightly higher activity of peroxisomal beta-oxidation was measured in the males of the high-dosed group in comparison to control; while a lower activity was measured in the females of the same group.
The toxicological significance of the above effects is not clear. Because of the equivocal nature of most of the effects, the 50000 ppm concentration was considered the NOAEC of this study.
In 13-week study, groups of 10 male and 10 female Sprague-Dawley rats were exposed to 0, 5000, 15000 and 50000 ppm (0, 24544, 73632 and 245440 mg/m3) HFC 125 (6 hrs/day, 5 days/week). Additional groups of 10 male and 10 female rats were designated for a 4-week recovery period (Nakayama et al., 1993). No mortality was found at any dose. There were no treatment-related clinical signs of toxicity or significant differences in body weight gains and food consumption among the control and the treated groups. No statistical differences were observed in haematology, blood biochemistry and urinalysis, in organ weights and in peroxisomal beta-oxidation activities. No treatment-related changes were observed during the gross pathology and histopathological examinations. 50000 ppm, was considered the NOAEC for this study.
No chronic toxicity study is available. However, the long-term repeated toxicity study can be waived in accordance with Column 2 of REACH Annex X, since:
- no serious or severe effects were observed in the available subacute and subchronic studies up to 50000 ppm v/v;
- the occurrence of toxic effects following chronic exposure to HFC 125 is not to be expected.
- no dangerous properties not detected in the 90-day study are to be expected.
Justification for classification or non-classification
No sign of toxicity observed up to 50000 ppm (245440 mg/m3). No Classification is warranted.
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.
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