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EC number: 200-891-8 | CAS number: 75-68-3
- 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:
- repeated dose toxicity: inhalation
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant near-guideline study, available as confidential study report and published in peer-reviewed literature, no restrictions, fully adequate for assessment (SIDS score: 1b)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
- Reference Type:
- publication
- Title:
- Toxicological evaluation of hydrochlorofluorocarbon 142b
- Author:
- Seckar JA, Trochimowicz HJ, Hogan GK.
- Year:
- 1 986
- Bibliographic source:
- Fd Chem. Toxic., 24, 237-240
Materials and methods
- Principles of method if other than guideline:
- Combined 2-year whole body inhalation chronic toxicity and carcinogenicity study with rats
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1-chloro-1,1-difluoroethane
- EC Number:
- 200-891-8
- EC Name:
- 1-chloro-1,1-difluoroethane
- Cas Number:
- 75-68-3
- Molecular formula:
- C2H3ClF2
- IUPAC Name:
- 1-chloro-1,1-difluoroethane
- Details on test material:
- Name of test material: 1-chloro-1,1-difluoroethane
.
Provided by the Pennwalt Corporation, Calvert City, KY. The test-material was presented as compressed form in several 750 kg gas cylinders provided periodically by the supplier over the 2 year exposure periode, with a purity level ranging from 99.85 to 99.99%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeging Laboratories, Wilmington, MA
- Age at study initiation: 7 weeks
- Housing: individually in suspended, stainless-steel, mesh cages
- Diet: Purina Lab Chow 5001, Ralston Purina co. Inc., St. Louis, MO, ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 C
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 10 m3 Rochester-design chamber
- Exposure generation: Test material passed through 0.5 inch diameter copper tubing immersed in an ethylene glycol chilled bath and through a liquid volume flowmeter prior to division into three delivery lines, volatilisation at 38 oC.
- Source of air: filtered, temperature- and humidity-controlled, non-recirculated air
- Air flow rate: 2.06-3.4 m3/min
- Air change rate: 12.4-20.4 air changes/hour
TEST ATMOSPHERE
- Brief description of analytical method used: gas liquid chromatography with flame-ionization detector - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- On-line gas-liquid chromatography (Tracor model 550 equipped with a flame-ionization detector, 5% OV-101 on 80-100 mesh Supercoport column, 50 oC column temperature and 200 oC detector temperature).
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- 6 hours per day, 5 days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000, 10000 and 20000 ppm (0.1, 1.0 and 2.0%, v/v)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.099 +/- 0.02, 1.01 +/- 0.11 and 1.95 +/- 0.20% (v/v)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 110/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
Examinations
- Observations and examinations performed and frequency:
- - Mortality/gross signs: twice daily
- Bodyweight: weekly during weeks 1-14 and 81-104 and biweekly during weeks 16-80
- Clinical observations and pulpations: weekly;
- Ophtalmoscopic exams: yearly;
- Hematology, clinical chemistry and urinalysis: 10 animals/sex/group at 12, 18 and 24 months of treatment. - Sacrifice and pathology:
- - Sacrifices were conducted on 10 animalss/sex/group at 12 months and on all survivors at 24 months.
- Organs weighted: brain, pituitary, lungs, liver, kidneys, speen, adrenals, gonads and thymus
- Morphological exams: adipose tissue, abdominal aorta, adrenals, bone marrow, femur, brain (3 sections), Zymbal gland, oesophagus, eyes, optic nerve, lacrimal gland, ovaries, testes with epididymis, heart, whole intestin, kidneys, liver, lungs, lymph nodes, mammary gland, nasal turbinates, pancreas, pituitary, prostate, salivary glands, sciatic nerve, skeletal muscle, skin, spinal cord, spleen, thymus, trachea , thyroid, parathyroid, urinary bladder, uterus, all gross lesions and tissue masses (all these tissues were preserved from all animals; all rats from control and high dose groups were examined microscopically). - Statistics:
- Parametric data: F distribution and Dunett's test;
Non-parametric data: Kruskal-Wallis and Dunn summed rank tests;
Equality of variance: Bartlet's test;
Neoplastic lesions and survival: NCI statistical programs.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- 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 specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- MORTALITY
Mortality was higher than expected for treated and control groups during the first year, reaching 11-16 and 2-10% in treated male and female groups, respectively, and 12 and 8% in ale and female controls, by week 52. Clinical signs and macroscopic pathology suggested a respiratory infection in some animals. Microscopic pathology confirmed the presence of bronchopneumonia in some treated and control animals. Diagnostic microbiology failed to identify either a consistent pathogen or the cause/origin. Neither the health status nor the mortality compromised the studies or the conclusions.
The survivorship figures at termination of exposure did not show dose-related effect on mortality in the treated males or females throughout the study.
CLINICAL SIGNS
Most significant signs were respiratory distress which were considered factors in several increases of mortality: control group males betweeen weeks 48 and 72 and low dose female group between weeks 40 and 48 and between weeks 72 and 80. However adequate number of animals in these groups survived the 2-year period and the effect of this respiratory distress was considered to be insignificant as far as toxicological and oncogenic assessment of the test material is concerned.
BODY WEIGHT AND WEIGHT GAIN
Inter-group differences in body weight that occured during the study did not indicate any exposure-related responses to 1-chloro 1,1-difluoroethane.
OPHTHALMOSCOPIC EXAMINATION
Exams at weeks 52 and 104 did not indicate any responses to exposure.
HAEMATOLOGY
The mean hematology values for the treated males and females were comparable to the control animals at 12, 18 and 24 month intervals and were within normal biological limits.
CLINICAL CHEMISTRY
In the low dose female group a statistically significant increase of the mean creatinine phosphokinase value (P < 0./05 by Dunnett's test) was observed at 12 months but not therafter at 18 and 24 months. In addition there was no such increase in mid and high dose groups, at any time and the the effect was considered not related to exposure. This finding was attributed to abnormally low control values. All other clinical chemistry values in both treated males and females were comparable to control animals and all parameters were considered within normal biological limits.
URINALYSIS
There were no differences from control values in any of the urine parameters evaluated which were considered related to the administration of the test material. Fluoride levels were comparable between treated and control animals.
ORGAN WEIGHTS
The values were considered within the range of normal expectation and there were no treatment related changes of absolute and relative organ weights.
GROSS PATHOLOGY
Findings at necropsy of decedents or those rats sacrificed after 12 or 24 months of treatment, as well as those dying spontaneously or sacrificed in a moribund condition throughout the study, were considered typical for rats of similar age and strain and no treatment-related effects were apparent.
HISTOPATHOLOGY: NON-NEOPLASTIC
Non-neoplastic microscopic pathology findings at the interim and final sacrifices were similar in treated and control groups and were confined to degenerative lesions typical of rats of this strain and age.
HISTOPATHOLOGY: NEOPLASTIC
Neoplastic findings in animals that died during the study or in survivors to termination were similar in all groups and comprised predominently tumours of the mammary and subcutaneous tissues in females, and pituitary and adrenal adenomas in both sexes. No treatment-related increases in tumours of the respiratory tract were noted.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 20 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects at the highest level tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Rats receiving exposures to atmosphere of 1-chloro -1,1-difluoroethane at concentrations up to 20000 ppm for 6h/d, 5d/w during 104 weeks, showed no treatment-related effects upon mortality, body weight, hematology, clinical chemistry, urinalysis and ophtalmological examinations, histopathological evaluation of selected tissues, or statistical analysis of neoplasms incidences. The NOAEL was established to exceed 20000 ppm (the highest dose tested).
- Executive summary:
1-chloro-1,1-difluoroethane was administered to three groups of Sprague-Dawley rats (110/sex/group) at exposure levels of 1000, 10000 and 20000 ppm (0.1, 1.0 and 2.0%, v/v) for 6 h/d, 5 d/week, for 104 weeks. Approximately 40% of the animals survived the duration of the study and the mortality was considered to be unaffected by the treatment. Statistically significant changes in body weight, hematological, clinical chemistry and organ weight values occurred sporradically and were considered to be no attributable to the treatment. Ophthalmology and urinalysis were not remarkable. Also no treatment-related effects were found upon histopathological evaluation of selected tissues or statistical analysis of neoplasm incidence data. The NOAEL was established to exceed 20000 ppm.
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