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EC number: 200-831-0 | CAS number: 75-01-4
- 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:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP non-guideline study, published in peer-reviewed literature, minor restrictions in design and reporting, but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Inhalation toxicity of vinyl chloride and vinylidene chloride.
- Author:
- Lee CC, Bhandari JC, Winston JM, House WB, Peters PJ, Dixon RL, Woods JS
- Year:
- 1 977
- Bibliographic source:
- Environ Health Perspect 21:25-32.
Materials and methods
- Principles of method if other than guideline:
- 12 months whole-body inhalation exposure of rats to vinyl chloride
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Chloroethylene
- EC Number:
- 200-831-0
- EC Name:
- Chloroethylene
- Cas Number:
- 75-01-4
- Molecular formula:
- C2H3Cl
- IUPAC Name:
- chloroethene
- Details on test material:
- - Name of test material (as cited in study report): vinyl chloride (VC)
- Physical state: gaseous
- Analytical purity: 99.8%
- Supplier: Matheson Products
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Lab
- Age at study initiation: about 2 months
- Housing: 2 per cage, in stainless steel cages with wire bottoms
- Diet: pulverized or block laboratory chow (Wayne Manufacturing Company), ad libitum, except during exposure
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 1.3 C
- Humidity (%): 25-60% at the start of the experiment, later regulated at 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: cubical inhalation chamber, made of stainless steel
- Method of holding animals in test chamber: caged
- Volume: 3.5 m3
- VC was metered with rotameters into the chamber air supply
TEST ATMOSPHERE
- Brief description of analytical method used: initially chamber air was sampled with a syringe and monitored using a gas chromatograph (Varian-2700) with a flame ionization detector. An automatic sampling system was later used. Periodically, a sample was directed to the gas chromatograph and the readout was processed by a Varian CDS 111 electronic integrator. The integrator was programmed to measure peak area and to calculate chamber concentrations by external standards. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Initially chamber air was sampled with a syringe and monitored using a gas chromatograph (Varian-2700) with a flame ionization detector. An automatic sampling system was later used. Periodically, a sample was directed to the gas chromatograph and the readout was processed by a Varian CDS 111 electronic integrator. The integrator was programmed to measure peak area and to calculate chamber concentrations by external standards.
- Duration of treatment / exposure:
- 12 months
- Frequency of treatment:
- 6 h/d, 5 d/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50 ppm, 250 ppm, 1000 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 36/sex/dose
- Control animals:
- yes
- Details on study design:
- - Section schedule rationale (if not random): four animals of wach exposure level were terminated for various laboratory tests, gross and histopatologic examinations at the end of 1, 2, 3, 6 and 9 months; the surviving animals were terminated at the end of 12 months.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS:
- All animals were observed throughout the study for adverse signs.
BODY WEIGHT:
- Body weights were measured biweekly at a uniform time of day.
FOOD CONSUMPTION:
- Food consumption was measured weekly at a uniform time of day.
HAEMATOLOGY:
- RBC, reticulocyte, platelet, WBC and differential countsm, nucleated RBC, hematocrit, hemoglobin, methemoglovin and Heinz bodies were determined in aortic blood from four males and four female of each group at interim and final terminations.
CLINICAL CHEMISTRY:
- Clinical blood chemistry (SGPT and BUN), as well as prothrombin time, SGOT, alkaline phosphatase, bilirubin, creatinine, LDH, alpha-HBDH, immunoglobin IgA, IgB-A, IgB-B and IgM, total protein, albumin, glubolun (by difference) and collagen contents in liver and lung were determined on samples from four males and four female of each group at interim and final terminations.
- Sacrifice and pathology:
- GROSS PATHOLOGY:
- Gross examination, especially for any appearance of abnormal growth or other lesions, was carefully performed on all tissues including the brain, pituitary, thyroids, respiratory tract, alimentary canal, urogenital organs, thymus, heart, liver, pancrease, spleen, mesenteric lymph nodes, and body cavities. The brain, liver, kidneys, spleen and gonads were removed and weighed.
HISTOPATHOLOGY:
- Tumors with adjacent normal tissues and the whole or portions of the various tissues were fixed, processed, sectioned, and stained for microscopic examination. All external and internal tumors were carefully examined and identified histologically. - Other examinations:
- Macrophage counts of pulmonary washings and cytogenic analysis of bone marrow cultures were performed on the control and abunaks receiving 1000 ppm VC. Limbs from the longest exposed animals were examined for osteoporosis or malacia using a senograph X-ray machine. They were examined for the presence of any bone tumors, any changes in bone density, cortical thickness or striations within the bone cortex, any loss of bone cortex, or any unusually trabecular pattern of the bone. Other specific studies including 14C-thymidine incorporation into DNA, hepatic aminolevulinic acid (ALA) synthetase, urinary ALA assays and alpha-fetoprotein were performed as well.
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 examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- 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 MORTALITY
No remarkable adverse signs were seen in any rats during the first 7 months. Two females exposed to 50 ppm, 4 males and 10 females exposed to 250 ppm, and 8 males and 13 females exposed to 1000 ppm died or were terminated between 8 and 12 months due to moribund appearance. No deaths occurred in controls.
BODY WEIGHT AND WEIGHT GAIN
Body weights of animals exposed to 50 or 250 ppm were not significantly different from controls throughout the study. The body weights of females exposed to 1000 ppm were less than controls after 4 weeks.
HAEMATOLOGY
No significant differences in hematology were noted between animals exposed to vinyl chloride or controls.
CLINICAL CHEMISTRY
No significant differences in clinical blood chemistry, collagen in liver and lung, urinary ALA level, serum ALA synthetase and serum alpha-fetoprotein were found between animals exposed to vinyl chloride or controls.
GROSS PATHOLOGY:
Hepatic and/or pulmonary hemangiosarcoma occurred in rats exposed to 250 or 1000 ppm of VC during the ninth through the 12th months; the incidence increased with increases in VC levels and length of exposure. Most of these rats died or were terminated ahead of schedule. The rats with hepatic hemangiosarcoma usually developed pulmonary hemangiosarcoma. In addition, hemangiosarcoma occasionally occurred in other tissues including omentum, mesentery, or subcutaneous tissue of rats exposed to 50, 250 or 1000 ppm VC. Hemangiosarcoma was not found in the liver, lung or any other organs of any control rats.
A few other tumors occasionally occurred in one or several rats. The tumors included a small nodule of bronchiolo-aleolar adenoma; reticulo-entothelial cell carcinoma or hepatoma in the liver; ductular adenocarcinoma or fibroadenoma in the mammary gland of the female; malignant lymphoma in the spleen or other organs adenoma in the kidney; squamous cell carcinoma, keratoacanthoma or fibroma in the skin; adenocarcinoma in the sebaceous gland, and chromophobe cell adenoma in the pituitary. These occasional tumors were not related to VC treatment.
OTHER FINDINGS:
A few controls and a few rats treated with VC showed a focal disseminate vacuolization, probably fatty change in livers.
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 50 ppm
- Sex:
- male/female
- Basis for effect level:
- other: Increased mortality at all dose levels
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Tumor incidence* |
0 |
50 |
250 |
1000 |
||||
Male |
Female |
Male |
Female |
Male |
Female |
Male |
Female |
|
Liver hemangiosarcoma |
0/35 |
0/35 |
0/36 |
0/36 |
2/36 |
10a/34 |
6/34 |
15a,b/36 |
Lung hemangiosarcoma |
0/35 |
0/35 |
0/36 |
0/36 |
0/36 |
3/34 |
4/34 |
9a/36 |
Hemangiosarcoma in other organs |
0/35 |
0/35 |
1/36 |
1/36 |
2/36 |
0/34 |
0/34 |
1/36 |
* Total incidence in 12 months
aSignificantly different from incidence in control group by Fischer exact probability test (Siegel, 1956), p<0.05
bSignificantly different from incidence in opposite sex exposed to the same concentration by Fisher exact probability test (Siegel, 1956), p< 0.05
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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