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EC number: 204-825-9 | CAS number: 127-18-4
- 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:
- other: Carcinogenicity study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, near guideline study, published study report, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Principles of method if other than guideline:
- Carcinogenicity study, which was conducted to modern regulatory standards
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tetrachloroethylene
- EC Number:
- 204-825-9
- EC Name:
- Tetrachloroethylene
- Cas Number:
- 127-18-4
- Molecular formula:
- C2Cl4
- IUPAC Name:
- tetrachloroethene
- Details on test material:
- - Name of test material (as cited in study report): tetrachloroethylene- Analytical purity: 99.9%- Lot/batch No.: two batches: TA03116F-01 and TA08190D- Stability under test conditions: yes. Tetrachloroethylene was found to be stable for 2 weeks at 60ºC- Storage condition of test material: stored at 0ºC
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Breeding Laboratories (Kingston, NY)- Age at study initiation: 8-9 weeks- Housing: stainless steel wire, 1 animal per cage- Diet: ad libitum, except during inhalation exposure- Water: ad libitum, also during inhalation exposure- Acclimation period: 21 daysENVIRONMENTAL CONDITIONS- Temperature (°F): 67-83- Humidity (%): 20-83 - Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTIONTetrachloroethylene was pumped from a stainless steel reservoir to a vaporizer by a stable micrometering pump. Tetrachloroethylene was vaporized at 100ºC-110ºC, diluted with air, and introduced into the chambers. The tetrachloroethylene vapor entered the fresh air duct and was led directly into the exposure chamber.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations in the exposure chambers were monitored 8-12 times per exposure period by a gas chromatograph. Mean concentrations measured in the exposure chambers were 99.5 ± 6.6, and 201 ± 11 ppm for target concentrations 100 and 200 ppm, respectively.
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- 6 hours per day, 5 days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:100, 200 ppmBasis:nominal conc.
- Remarks:
- Doses / Concentrations:99.5 +/- 6.6, 201 +/- 11 ppm (mean +/- SD)Basis:analytical conc.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The exposure concentrations used were selected on the basis of results from 13-week inhalation studies in which groups of 10 mice of each sex were exposed to tetrachloroethylene at 100-1600 ppm for 6 hours per day, 5 days per week. During the 13-week study, 1600 ppm tetrachloroethylene was lethal to 20-70% of the animals and reduced the final body weights of the survivors. In dosed male and female mice, minimal to mild hepatic leukocytic infiltration, centilobular necrosis, bile stasis (400-1600 ppm), and mitotic alteration (200-1600ppm) were produced. Tetrachloroethylene exposure also caused minimal renal tubular cell karyomegaly in mice at concentrations as low as 200 ppm.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, two times per dayDETAILED CLINICAL OBSERVATIONS: Yes, clinical signs recorded at least once per monthBODY WEIGHT: Yes, individual body weights were recorded once per week for the first 13 weeks of the study and once per month thereafter. FOOD CONSUMPTION: No data (ad libitum) WATER CONSUMPTION: No data (ad libitum)
- Sacrifice and pathology:
- Necropsy was performed on all animals, including those found dead, unless they were excessively autolyzed, or cannibalized, missexed, or found missing. During necropsy, all organs and tissues were examined for grossly visible lesions. Tissues were preserved in 10% neutral buffered formalin, embedded in paraffin, sectioned and stained with hematoxylin and eosin.NOTE: nonneoplastic lesions are not examined routinely unless they are considered part of the toxic effect of the chemical.
- Statistics:
- - Survival analyses: product-limit procedure of Kaplan and Meier (1958)- Calculation of incidence: incidence of neoplastic of nonneoplastic lesions is given as the ratio of the number of animals bearing such lesions at a specific anatomic site to the number of animals in which that site was examined. - Analysis of tumor incidence: three methods were used: life table analyses (Cox, 1972 and Tarone, 1975 / incidental tumor analyses (Haseman, 1984) / unadjusted analyses (Fisher exact test for pairwise comparisons and the exact Cochran-Armitage linear trend test (Armitage, 1971; Gart et al, 1979)).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- 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:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITYSurvival was decreased in males (control 46/49; low dose 25/50; high dose 32/50) and in females (control 36/49; low dose 31/50; high dose 19/50).The survival of the low dose (after week 74) and high dose (after week 78) male groups and the high dose female group (after week 90) was signifcantly lower than that of the controls. BODY WEIGHT AND WEIGHT GAINMean body weights and weight gain of dosed and control groups were comparable throughout the study.GROSS PATHOLOGY AND HISTOPATHOLOGYKidney: - Concentration-related increases in renal tubular cell karyomegaly were obtained in the exposed males (control 4/49; low dose 17/49; high dose 46/50) and females (control 0/48; low dose 16/49; high dose 38/50).- The incidence of nephrosis was also increased in the exposed females (control 5/48; low dose 14/49; high dose 25/50), and tubular cell casts were observed at higher incidences in test males (control 3/49; low dose 9/49; high dose 15/50) and females (control 4/48; low dose 4/49; high dose 15/50). Liver: - Degeneration, characterised by hepatocellular necrosis, cytoplasmic vacuolation, inflammatory infiltration and regenerative foci, showed increased incidence in males (control 2/49; low dose 8/49; high dose 14/50) and females (control 1/49; low dose 2/50; high dose 13/50).- Necrosis: 1/49; 6/49; 15/50 (males) and 3/48; 5/50; 9/50 (females).- Nuclear inclusions: 2/49; 5/49; 9/50 (males).Lung: The number of mice with (acute passive) congestion of the lungs was increased in the exposed males (control 1/49; low dose 8/49; high dose 10/50) and females (control 1/48; low dose 5/50; high dose 6/50).
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 100 ppm
- Sex:
- male/female
- Basis for effect level:
- other: liver lesions (degeneration, characterised by hepatocellular necrosis, cytoplasmic vacuolation, inflammatory infiltration and regenerative foci), kidney damage (tubular cell karyomegaly, nephrosis and casts) and congestion of the lungs
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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