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Diss Factsheets
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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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Meets generally accepted scientific standards, limited documentation, acceptable for assessment, MTD not reached
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of 1,2-dichloroethane and 1,1,1-trichloroethane in drinking water on reproduction and development in mice
- Author:
- Lane RW, Riddle BL & Borzelleca JF
- Year:
- 1 982
- Bibliographic source:
- Toxicol. Appl. Pharmacol. 63: 409-421
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Limitations included
- Dosing: 35 d premating dosing only. No exposure during pregnancy and lactation. No MTD reached: No toxic effect noted at any of the doses used. - Examination: Necropsy performed on pups, but no pathology and histopathology documented. No sperm parameters reported. - GLP compliance:
- not specified
- 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
- Source: Aldrich Chemical Co., Milwaukee, Wisc., USA
- Purity: >99 %
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Flow Laboratories, Dublin, VA, USA
- Age: 7 weeks old
- Housing: On sawdust bedding in polycarbonate cages
- Diet: Purina Rodent Laboratory Chow 501, ad libitum
- Water: drinking solution, ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: 22-23 degree C
- Humidity: 40-60 %
- Photoperiod: 12 hours dark / 12 hours light
Males were housed singly; females were kept three per cage, except during parturition and lactation, when they were housed one per cage. Males and females were co-housed (1:3, respectively) for 7 days at each mating. Litters were weaned at 21 days of age.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: 1% solution of Emulphor EL-620
- Details on exposure:
- The test substance was administered with the drinking water containing 1 % Emulphor EL-620 at 0.03, 0.09, and 0.29 mg/mL, designed to yield doses of 5, 15, or 50 mg/kg bw/d. No aversion to the vehicle or the test substance was observed. Fresh drinking water solutions were prepared twice daily. The highest dose was chosen to provide approx. 1/10 of the LD50.
- Details on mating procedure:
- Matings between siblings were avoided. Males and females were co-housed (1:3, respectively) for 7 days at each mating.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data on analytical verification of doses.
- Duration of treatment / exposure:
- Exposure period: none during pregnancy and lactation
Premating exposure period (males): 5 weeks (F0); 11 weeks (F1)
Premating exposure period (females): 5 weeks (F0); 11 weeks (F1)
Duration of test: 25 wk and 24 wk in F0 and F1B animals, resp. - Frequency of treatment:
- daily
- Details on study schedule:
- After 35 days of treatment, F0-generation was mated to produce an F1A generation (10 males, 30 females). Two weeks after weaning of the offspring, the same adults were mated again to produce an F1B generation and subsequently an F1C generation applying the same mating regimen. The F1A generation was subjected to necropsy on postnatal day 21, i.e. after weaning, while F1B mice were mated after weaning (three wk) and a further 11 wk of treatment to produce F2A and, two wk after weaning of the F2A generation, F2B. The F2A generation was autopsied on postnatal day 21.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
ca. 0, 5, 15 or 50 mg/kg bw/d (30, 90 or 290 mg/L)
Basis:
nominal in water
- No. of animals per sex per dose:
- F0: 10 males and 30 females
F1: 10 males and 30 females - Control animals:
- yes, concurrent no treatment
- Details on study design:
- no further details given
- Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- Weekly body weight and twice-weekly fluid consumption data were collected for the F0 and F1B adult mice throughout the study. Mean body weights were analysed similarly. Adult percentage mortality was calculated at the termination of each generation (25 weeks of dosing for the F0; 24 for the F1B). Mice found moribund or sacrificed at the end of the study were necropsied.
- Oestrous cyclicity (parental animals):
- Weights of rats showing vaginal smears were recorded on days 0, 6, 14, and 21 of gestation.
- Sperm parameters (parental animals):
- not investigated
- Litter observations:
- Twenty-one-day survival studies were performed on litters from F1 and F2 matings. Litter size was recorded on Days 0, 4, 7, 14, and 21. Litters were randomly culled to 10 pups each on day 4. Offspring were weighed collectively on days 7 and 14 and individually on day 21. All pups from each litter were sacrificed and necropsied at the conclusion of each 21-day survival study.
- Postmortem examinations (parental animals):
- Mice found moribund or sacrificed at the end of the study were necropsied.
- Postmortem examinations (offspring):
- All pups from each litter were sacrificed and necropsied at the conclusion of each 21-day survival study.
- Statistics:
- Group differences in body weight and fluid uptake were evaluated by Duncan's multiple range test. Adult reproductive performance was evaluated by fertility and gestation indices. Evaluation of litter data included Kruskal-Wallis test and Dunn's test. Level of significance chosen was always p<0.05.
- Reproductive indices:
- Adult reproductive performance was evaluated by calculation of fertility and gestation indices.
- Offspring viability indices:
- Viability and lactation indices were calculated.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No adverse reproduction effects up to highest dose used in the study.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 50 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No adverse reproduction effects up to highest dose used in the study.
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- ca. 50 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No adverse reproduction effects up to highest dose used in the study.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Dominant lethal screening:
Statistically significant effects in the ratio of dead to live fetuses were observed in both generations. However, these effects, which were both increases and decreases compared to controls, did not appear to be dose related.
Teratogenicity screening:
Maternal ingestion of the test compound produced no apparent adverse reproductive effects or increased incidence of fetal visceral or skeletal anomalies.
Applicant's summary and conclusion
- Conclusions:
- There appeared to be no dose-dependent effects on fertility, gestation, viability, or lactation indices. Pup survival and weight gain were not adversely affected. 1,2 -dichlororethane failed to produce significant dominant lethal mutations or teratogenic effects in either of the two generations tested.
- Executive summary:
A multigeneration reproduction study was modified to include screening for lethal and teratogenic effects of 1,2 -dichloroethane in drinking solution (Emulphor: deionized water, 1:99, v/v). Male and female (10 and 30/dose level, respectively) ICR Swiss mice received 1,2 -dichloroethane at concentrations of 0, 0.03, 0.09 or 0.29 mg/mL. These concentrations were designed to yield daily doses of 0, 5, 15 or 50 mg/kg bw/d. No taste aversion was evident. There appeared to be no dose-dependent effects on fertility, gestation, viability, or lactation indices. Pup survival and weight gain were not adversely affected. 1,2 -dichlororethane failed to produce significant dominant lethal mutations or terata in either of the two generations tested.
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