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EC number: 203-458-1 | CAS number: 107-06-2
- 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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Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-dichloroethane
- EC Number:
- 203-458-1
- EC Name:
- 1,2-dichloroethane
- Cas Number:
- 107-06-2
- Molecular formula:
- C2H4Cl2
- IUPAC Name:
- 1,2-dichloroethane
- Details on test material:
- - Name of test material: 1,2-dichloroethane
- Analytical purity: 99 %
- Impurities: less than 0.03 % water, less than 0.0005 % chlorine, less than 0.002 % non-volatile chemicals
- Source: Wako Pure Chemical Industries, Ltd., Osaka, Japan
Each lot of test substance used in this study was analyzed for its purity and stability by gas chromatography before and after use. Neither decomposition products nor other impurities were detected.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc., Kanagawa, Japan
- Age at study initiation: 6 weeks old
- Weight at study initiation: 120 ± 5 g
- Housing: Individually in stainless steel wire hanging cages (150 mm x 220 mm x 176 mm)
- Diet: Commercial pellet diet (CRF-1, Oriental Yeast Co., Ltd., Tokyo, Japan), ad libitum
- Water: Sterilised water, ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 degree C
- Humidity: 55 ± 10 %
- Air changes: 12 ± 1 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- Airflow containing 1,2-dichloroethane vapor at a target concentration for rats of 10, 40 or 160 ppm was prepared by a vaporization technique. The saturated vapor-air mixture was generated by bubbling clean air through liquid 1,2-dichloroethane in a temperature-regulated glass flask (25 degree C), and by cooling it through a thermostatted condenser at 18 degree C. The airflow containing the saturated vapor was diluted with clean air, and then warmed to 25 degree C in a thermostatted circulator which served to stabilize the vapor concentration by complete gasification of 1,2-dichloroethane. The flow rate of vapor-air mixture was regulated with a flow meter, further diluted with humidity- and temperature-controlled clean air in a spiraling line mixer, and then supplied to the inhalation exposure chambers. Four inhalation exposure chambers of 7600 L in volume were used in this study. Each exposure chamber accommodated 100 individual cages for 50 males and 50 females.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chamber concentrations of 1,2-dichloroethane were monitored by gas chromatography every 15 min, and maintained constant at 10.0 ± 0.1, 39.8 ± 0.6 and 159.7 ± 2.1 ppm for the exposure of rats throughout the 2-year exposure period.
- Duration of treatment / exposure:
- 104 weeks, 6 hours per day
- Frequency of treatment:
- 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 40, or 160 ppm (0, 41.1, 164.5 or 658.1 mg/m³)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 50 animals
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Groups of 50 male and 50 female rats were exposed to airflow containing 1,2-dichloroethane vapor at a target concentration of 10, 40, or 160 ppm for rats for 6 h/d, 5 d/wk and for 104 wk (2 years). Fifty rats of both sexes, serving as concurrent controls, were handled in the same manner as the 1,2-dichloroethane-exposed groups, but were exposed to clean air in the inhalation exposure chambers. The lowest exposure concentration of 10 ppm was selected in consideration of the OEL of 10 ppm for 1,2-dichloroethane. Selection of the highest concentrations of 160 ppm for rats was based on both subchronic toxicity and body weight decrement from a preliminary 13-weeks inhalation exposure study conducted at the JBRC. All rats died during the first week of 13-weeks exposure to 320 ppm, but 13-weeks exposure to 160 ppm did not cause any deaths, overt toxic signs or body weight decrements. Therefore, the highest exposure concentration of 160 ppm was predicted not to exceed the MTD from the results of the 13-weeks inhalation exposure study.
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- The animals were observed daily for clinical signs and mortality. Body weights and food consumption were measured once a week for the first 14 wk, and every 4 wk thereafter.
- Sacrifice and pathology:
- All the rats which died or were killed in a moribund state during the 2-year exposure period, or survived to the end of the 2-year period received complete necropsy. Urinary parameters were measured from urine sampled with Ames Reagent Strips in the last week of the 2-year exposure period. For haematology and blood biochemistry, the surviving animals were bled under ether anaesthesia at terminal necropsy after they were fasted overnight. The blood samples were analyzed on an automatic blood cell analyzer for haematology, and an automatic analyzer Hitachi 705 and a flame analyzer Hitachi 750 for blood biochemistry. Organs were removed, weighed, and examined for macroscopic lesions at the necropsy. Tissues for microscopic examinations were fixed in 10 % neutral buffered formalin and embedded in paraffin. Tissue sections 5 µm thick were prepared and stained with haematoxylin and eosin.
- Other examinations:
- none
- Statistics:
- Incidences of neoplastic lesions were analyzed for a dose response relationship indicated by a significant positive trend by Peto’s test, and for a significant difference from the concurrent control group by Fisher’s exact test. Incidences of non-neoplastic lesions and urinary parameters were analyzed by Chi-square test. Survival curves were plotted according to the Kaplan- Meier method, and the log-rank test was used to test statistical significance of the difference between any 1,2-dichloroethane-exposed rat group of either sex and the respective control. Body weight, organ weight, haematological and blood biochemical parameters were analyzed by Dunnett’s test. When tumor incidences were increased in a dose-related manner as indicated by Peto’s test and when the tumor incidence in each of the exposed groups was increased but not statistically significant as compared with the concurrent, matched-control group by Fisher’s exact test, the borderline increase in the tumor incidence was tested as to whether or not it was biologically meaningful, using a range of minimum and maximum tumor incidences in the JBRC historical control data.
Results and discussion
Results of examinations
- 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 specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- 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:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- MORTALITY, BODY WEIGHT, FOOD CONSUMPTION AND CLINICAL OBSERVATIONS:
There was no significant difference in the survival rate at any time point of the 2- year exposure period between any exposed group of either sex and the respective control. At the end of the 2-year exposure period, the survival rates of the 0 (clean air as control), 10, 40 and 160 ppm exposure groups were 74, 70, 64 and 74 % for males, and 70, 82, 74 and 76 % for females, respectively. Neither growth rate nor food consumption was suppressed in any exposed group of either sex as compared with the respective control. The body weights of the 0, 10, 40 and 160 ppm exposure groups at the end of 2-year exposure period were 434 ± 46, 459 ± 59, 448 ± 41 and 467 ± 85 g for males, and 317 ± 46, 329 ± 41, 33 ± 45 and 336 ± 56 g for females, respectively. Incidences of subcutaneous masses, which were found in the breast, back, and abdominal and perigenital areas by clinical observation, tended to increase in the exposed groups of both sexes. No exposure-related change in any haematological, blood biochemical or urinary parameter was found in any exposed group of either sex.
HISTOPATHOLOGY:
For carcinogenicity please refer to IUCLID5 chapter 7.7
No exposure-related, non-neoplastic lesions were observed in any exposed group of either sex.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 658.1 mg/m³ air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed except of carcinogenicity
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 1,2-dichloroethane was shown to be carcinogenic after inhalation exposure to rats for a period of 2 years.
- Executive summary:
Carcinogenicity and chronic toxicity of 1,2- dichloroethane were examined by inhalation exposure of groups of 50 F344/sex/dose to 1,2- dichloroethane vapor or clean air as control for 6 h/d, 5 d/wk and 104 wk. The rats were exposed to 0, 10, 40 or 160 ppm (v/v) ( equivalent to 0, 41.1, 164.5 or 658.1 mg/m³) 1,2- dichloroethane. The 2-year exposure produced a dose-dependent increase in incidences of benign and malignant tumors, including subcutaneous fibroma, mammary gland fibroadenoma and peritoneal mesothelioma in male rats; subcutaneous fibroma and mammary gland adenoma, fibroadenoma and adenocarcinoma in female rats. No exposure-related change in the incidence of non-neoplastic lesions or in any haematological, blood biochemical or urinary parameter occurred in any exposed rat group. The types of tumors and their target organs found in this study were consistent with those observed in rats and mice administered 1,2 - dichloroethane by gavage in a NCI study. Selection of the exposure concentrations was considered appropriate with reference to the maximum tolerated dose for the highest doses and an occupational exposure limit of 1,2- dichloroethane for the lowest dose.
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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