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EC number: 200-872-4 | CAS number: 75-46-7
- 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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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- A group of 20 male and 20 female rats were exposed 6 hours/day for 90 days to 0 or 10000 ppm FKW 23 (also known as HFC-23). The following parameters were assessed: feces, food and water consumption, body weight gain, haematology, clinical biochemistry, urinalysis, sight, hearing, and dentition. Macroscopic and histologic pathologic examinations were performed.
Testing procedures were according to "Principles and Procedures for Evaluating the Toxicity of Household Substance", IV, page 14-19, publication 1138, National Academy of Science - National Research Council, Washington DC, 1984. - GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S. Ivanovas GmbH & Co.
- Age at study initiation: 37 days for the males, 39 days for the females
- Weight at study initiation: Between 100 - 105 g
- Fasting period before study: no
- Housing: Animals were kept in groups of 3 or 2 in Macrolon cages (type III)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/- 0.5 deg C (maximum range)
- Humidity (%): 60% +/-3% (maximum range)
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
All this data came from the report not the publication - Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION: Air/gas mixture was drawn by shunts from the exposure chamber and was verified via gas chromatography. In preliminary testing, it was checked that a complete and even distribution in the air-flow through the exposure chamber wsa ensured.
- Exposure apparatus: exposure chamber was 3 m3 (length: 3m, width: 1 m, height: 1 m)
- Method of holding animals in test chamber: Macrolon cages of the whole group were transferred to the exposure chamber
- Source and rate of air: Compressed air supply
- Method of conditioning air: Air cleaning with potassium dichromatesulphuric acid, sodium hydroxide, glass wool, and calcium chloride
- System of generating particulates/aerosols: not reported
- Temperature, humidity, pressure in air chamber: 21+/-3 deg C
- Air flow rate: not reported
- Air change rate: not reported
- Method of particle size determination: not reported
- Treatment of exhaust air: not reported
TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography.
- Samples taken from breathing zone: yes. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical verification was done via gas chromatography. Samples were obtained before the exposure period, and then at intervals of 1 hour until exposure ended. Immediate correction was made if the concentration differed 3% from the nominal values of 10,000 ppm by volume of air.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 6 hours/day
- Remarks:
- Doses / Concentrations:
0
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
10000 ppm
Basis:
nominal conc. - No. of animals per sex per dose:
- 20 per dose/sex
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: not reported
- Rationale for animal assignment (if not random): not reported - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Once a week (on the same day and at the same time of day)
FOOD CONSUMPTION: Yes
- Time schedule for examinations: Estimated daily by weighing residue (at the same time of day). Presence or absence of feces was noted.
FOOD EFFICIENCY: No
WATER CONSUMPTION: Yes, Intake of drinking water was noted.
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: After 13 weeks of treatment
- Anaesthetic used for blood collection: Yes, blood was drawn under light ether anesthesia from the retrobulbar venous plexus
- Animals fasted: No data
- How many animals: all animals
- Parameters checked in Table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Before the first exposure, after 7 test days as well as after 6 and 13 weeks of treatment
- Animals fasted: No data
- How many animals: all animals
- Parameters checked in Table No.2 were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: After 13 weeks of treatment
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No data
- Parameters checked in Table 2 were examined.
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: After 13 weeks of treatment, auditory acuty was checked with a simple noise test. Dentition was inspected. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see Table 3)
HISTOPATHOLOGY: Yes (see Table 3) - Statistics:
- Analysis of variance and Student's t-test were carried out. Limit for significance was p <= 0.01.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No changes were observed in the behavior of the rats administered FKW 23. There were no differences in the external appearance of experimental and control animals. None of the rats died prematurely. Feces appeared normal.
BODY WEIGHT: Body weights were not affected by test substance adminstration.
FOOD CONSUMPTION: Food consumption wsa within the normal range during the entire administration period of 3 months.
WATER CONSUMPTION: Intake of drinking water seemed normal.
OPHTHALMOSCOPIC EXAMINATION: No pathological findings were observed in the eyes of rats after 3 months of administration of HFC 23 by inhalation.
HAEMATOLOGY: After 3 months' administration of HFC 23 by inhalation, the blood picture (haemoglobin, erythrocyte-, leucocyte- and differential count) showed no changes. The determination of haematocrit value, blood clotting time and methaemoglobin as well as reticulocyte- and platelet count revealed no pathological findings. HEINZ bodies were not detected.
CLINICAL CHEMISTRY: During and/or after 3 months of treatment with HFC 23 by inhalation, normal serum levels were found for glucose, total bilirubin and protein, blood urea, sodium, potassium, chloride, calcium, uric acid, creatinine, total cholesterol and total lipids. The activity of the serum alkaline phosphatase (AP) and glutamic oxalo-acetc transaminase (GOT) was not increased. This can also be said for the serum gluatmic pyruvic transaminase (GPT); a significantly increased value in the males on test day 7 was not confirmed in the females or at later dates; according to the experience of the laboratory, this finding wsa classified as an incidental finding. Neither electrophoresis of the serum proteins nor bromsulphthalein test showed definate signs of intolerance phenomena.
URINALYSIS: After treatment of 3 months with HFC 23, no pathological changes which might be attributed to the test chemical were detected in the composition of the urine. Leucocytes in the sediment of one animal were attributed to the sphere of spontaneous pathology.
ORGAN WEIGHTS: The only significant difference was in the thyroid of the females, this organ being reduced in both absolute and relative terms. According to the experience of the laboratory, this finding was said to be without meaning.
HISTOPATHOLOGY: Histology revealed no pathological changes attributable to HFC 23. Areas of focal over-inflation were found to the same extent in the lungs of both experimental and control rats. Individual changes in other organs were regarded as belonging to the domain of spontaneous pathology.
OTHER FINDINGS: A simple noise test did not indicate any impairment of auditory acuity. Dentition was free from pathological changes. - Dose descriptor:
- LOAEL
- Effect level:
- > 10 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were noted at the highest level tested.
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were noted at the highest level tested.
- Critical effects observed:
- not specified
- Conclusions:
- This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
No adverse effects were noted in any of the parameters assessed. Histologic examination revealed no compound-related pathologic changes. - Executive summary:
A group of 20 male and 20 female rats were exposed 6 hours/day for 90 days to 0 or 10000 ppm HFC-23. The following parameters were assessed: feces, food and water consumption, body weight gain, haematology, clinical biochemistry, urinalysis, sight, hearing, and dentition. Macroscopic and histologic pathologic examinations were performed. No adverse effects were noted in any of the parameters assessed. Histologic examination revealed no compound-related pathologic changes. The LOAEL and NOAEL were > 10000 ppm HFC-23 (the highest dose tested).
Reference
No adverse effects were noted in any of the parameters assessed. Histologic examination revealed no compound-related pathologic changes.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 28 634 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Additional information
In a K2 inhalation study, groups of male and female rats were administered the substance at doses of 0 or 10000 ppm by inhalation for approximately 90 days. No substance-related adverse toxicity was observed in male or female rats. Under the conditions of the study, the no-observed-adverse-effect-level (NOAEL) for the substance was 10000 ppm, the highest concentration tested.
An additional 90-day inhalation study was conducted in male and female Beagle dogs at doses of 0 or 5000 ppm. No substance-related adverse toxicity was observed in male or female dogs. Under the conditions of the study, the no-observed-adverse-effect-level (NOAEL) for the substance was 5000 ppm, the highest concentration tested.
Justification for classification or non-classification
Based on the lack of adverse effects up to concentrations of 10000 ppm (28634 mg/m3) in rats and 5000 ppm (14317 mg/m3) in dogs in repeated dose inhalation studies, the substance does not need to be classified for repeated dose toxicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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