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EC number: 200-893-9 | CAS number: 75-71-8
- 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

Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects on experimental animals of long-term inhalation of trichloroethylene, carbon tetrachloride, 1,1,1-trichloroethane, dichlorodifluoromethane, and 1,1-dichloroethylene.
- Author:
- Prendergast JA, Jones RA, Jenkins LJ Jr, Siegel J.
- Year:
- 1 967
- Bibliographic source:
- Toxicol Appl Pharmacol., vol. 10, no. 2, p. 270-89.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
groups of animals were exposed to dichlorodifluoromethane daily for 30 exposures, or as a continuous exposure for 90 days.
- Short description of test conditions:
- Parameters analysed / observed: - GLP compliance:
- no
- Remarks:
- Prior to GLP guidelines
- Limit test:
- yes
Test material
- Reference substance name:
- Dichlorodifluoromethane
- EC Number:
- 200-893-9
- EC Name:
- Dichlorodifluoromethane
- Cas Number:
- 75-71-8
- Molecular formula:
- CCl2F2
- IUPAC Name:
- dichlorodifluoromethane
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Matheson Gas Company, East Rutherford, New Jersey
Test animals
- Species:
- other: rats, guinea-pigs, monkeys, rabbits, dogs
- Strain:
- other: as stated in the publication: 15 Sprague-Dawley or Long-Evans, 15 Hartley guinea-pigs, 3 squirrel monkeys, 3 New-Zealand rabbits, 2 beagle dogs
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 192 g (range: 145-244g) at start of the repeated exposure study; 213 g (range: 165-262g) at the start of the continuous exposure study
- Housing:
- Diet : not specified
- Water : ad libitum
- Acclimation period:
DETAILS OF FOOD AND WATER QUALITY: commercial dry chow.
ENVIRONMENTAL CONDITIONS : (exposure chambers)
- Temperature (°C): 75 to 80°F (23 to 26.7°C)
- Humidity (%): 50%
- Air changes (per hr): 1.23 m3/ minute
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: chamber (no details)
- Source and rate of air: no data
- Method of conditioning air: a stream of pure gaseous dichlorodifluoromethane from a high-pressure cylinder was metered through a rotameter into a mixing bottle and carried into the chember where it was diluted to the atrget concentration with air.
- Temperature, humidity, pressure in air chamber: 75-80°F (23.6-26.6 °C), 50% humidity, negative pressure at 2.0 inches if water
- Air flow rate: 1.25 m3/minute
- Air change rate: no data
- Treatment of exhaust air: no data
TEST ATMOSPHERE
- Brief description of analytical method used: continous monitoring of chamber concentrations by infrared analysis.
- Samples taken from breathing zone: no data
VEHICLE (if applicable)
- Justification for use and choice of vehicle: no data
- Composition of vehicle: air - Analytical verification of doses or concentrations:
- yes
- Remarks:
- Infrared analysis
- Details on analytical verification of doses or concentrations:
- Infrared analysis. A stream of chamber air was drawn through a variable pathlength gas cell fitted to an infrared spectrophotometer. The instrument was locked on the analytical wavelength selected for the contaminant and the percent transmission was continuously recorded. The contaminant level was then read from a graph of concentration vs percent transmission previously prepared by vaporizing known amounts of the test material in the gas cell.
Chemical analysis were performed daily and correlated with nominal input data. - Duration of treatment / exposure:
- - repeated exposure study: 30 exposures
- continuous exposure study: 90 days - Frequency of treatment:
- - Repeated exposures: Daily 8 hours/day, 5 days/week for a total of 30 exposures
- Continuous exposure for 90-day, except for feeding the animals and servicing the chambers (< 2% of the total chamber time)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/m³ air
- Dose / conc.:
- 4 136 mg/m³ air
- Remarks:
- 30 repeated exposures (Mean +/- SD 87)
- Dose / conc.:
- 3 997 mg/m³ air
- Remarks:
- 90-day continuous exposure (Mean +/- SD 113)
- No. of animals per sex per dose:
- 15 rats per dose (sex not specified)
- Control animals:
- yes, concurrent no treatment
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: yes
All animals were routinely examined for signs of toxicity, marked alterations in behaviour, physical appearance, respiration pattern, locomotor activity and prostration.
BODY WEIGHT: Yes
- Time schedule for examinations: prior to exposure, at monthly intervals and at the termination of the study.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: no data
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters examined : Total and differential Leukocyte counts, Hemoglobin concentration, Hematocrit, before and after the exposure
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters examined:
* Reduced nicotinamide adenine dinucleotide (NADH), reduced nicotinamide adenine dinucleotide phosphate ( NADPH), activities of succinic dehydrogenase ( SDH ), lactic dehydrogenase ( LDH), isocitric dehydrogenase ( ICD), glucose-6-phosphate dehydrogenase ( GGPD), and p-hydroxybutyric dehydrogenase (B-OHBD).
* Alkaline phosphatase activity
* Serum glutamic-pyruvic transaminase levels
* Serum urea nitrogen concentrations
* Liver lipids
URINALYSIS: Not specified
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes : heart, lung, liver, spleen, kidney
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Repeated exposure: No signs of toxicity were observed in the rat survivors.
Continuous exposure: no visible signs of toxicity - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Rats: (no details on day)
1/15 in the repeated exposure group
2/15 in the continuous exposure group
7/304 controls
Guinea-pigs:
1/15 in the continuous exposure group.
No mortality observed in the other groups and species. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- * Repeated exposure: no effect reported
* continuous exposure: No effects reported in rats. Body weights of the rabbits and guinea-pigs were depressed. - Food consumption and compound intake (if feeding study):
- not examined
- Ophthalmological findings:
- not examined
- Clinical biochemistry findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No details
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- * Repeated exposure: several rats and guinea pigs, had varying degrees of lung congestion.
Other organs appeared normal.
No effects were reported in rats, but guinea-pigs showed focal necrosis of the liver, but which could not be defintely attributed to the exposure.
* Continuous exposure: high incidence of varying degrees of lung congestion in rats, rabbits, monkeys, guinea-pigs.
In guinea-pigs, submassive necrosis of the liver was noted in the surviving guinea-pigs. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- * Repeated exposure: non-specific interstitial inflammatory changes in the lungs of both treated and control animals.
- Several guinea-pigs showed focal necrosis or fatty infiltration of the liver.
- one monkey had heavy pigment deposits in the liver, spleen, kidney.
* Continuous exposure: non-specific interstitial inflammatory changes in the lungs (all species)
- one guinea-pig showed a focal giant cell pneumonitis. All guinea-pig liver sections: slight to extensive fatty infliltration of the hepatic cells; several sections with focal or submassive necrosis of the liver. It could not be determined if this toxic response was due to the continuous exposure or to the higher susceptibility of the guinea-pigs, already noted in other studies. - Histopathological findings: neoplastic:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 3 997 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- not specified
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
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