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EC number: 229-227-5 | CAS number: 6441-82-3
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Route-to-route extrapolation of 1,2-dichloroethane studies from the oral route to inhalation using physiologically based pharmacokinetic models
- Author:
- Lisa M. Sweeney*, Michael L. Gargas
- Year:
- 2 016
- Bibliographic source:
- Regulatory Toxicology and Pharmacology 81 (2016) 468-479
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- Principles of method if other than guideline:
- Extended one generation toxicity (EOGRT) study of 1,2-dichloroethane in Rats
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- not specified
Test material
- Reference substance 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 (as cited in study report): 1,2-dichloroethane
- Molecular formula (if other than submission substance): C2H4Cl2
- Molecular weight (if other than submission substance): 98.9596 g/mole
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1,2-dichloroethane
- Molecular formula (if other than submission substance): C2H4Cl2
- Molecular weight (if other than submission substance): 98.9596 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- not specified
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Total: 216
0 mg/kg/day: 27 male, 27 female
50 mg/kg/day: 27 male, 27 female
150 mg/kg/day: 27 male, 27 female
300 mg/kg/day: 27 male, 27 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- Body weight and body weight gain were observed
- Oestrous cyclicity (parental animals):
- Estrous cyclicity in P females was evaluated.
- Sperm parameters (parental animals):
- Sperm count, motility, and morphology were determined for all adult males were examiined.
- Litter observations:
- Reproductive/developmental effects (Cohort 1), neurodevelopmental effects (Cohort 2), and developmental immune effects (Cohort 3) were examined.
- Postmortem examinations (parental animals):
- Oragn weight, gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- Fertility, gestation, vaginal opening and preputial separation were observed.
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Decrease in body weight and body weight gain were observed in treated rats as compared to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- As EDC in drinking water to have poor palatability; drinking water consumption was generally decreased, relative to Controls, in a dose-related manner.
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No microscopic changs were observed in treated P generation rats as compared to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effect was observed on estrous cycle of P generation as compared to contorl
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No effect was observed on sperm evalution of P generation male rats as compared to contorl
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on Fertility, gestation, vaginal opening and preputial separation of treated P rats were observed as compared to control.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 155 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- water consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive function (sperm measures)
- reproductive performance
- Remarks on result:
- other: No effect observed
- Dose descriptor:
- NOAEL
- Effect level:
- 182 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- water consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive performance
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No effect on neurodevelopmental (Cohort 2) were observed in F1 male and femlae rats.
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- no effects observed
- Description (incidence and severity):
- No effect on developmental immune effects (Cohort 3) were observed in F1 male and femlae rats.
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 184 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- developmental neurotoxicity
- developmental immunotoxicity
- Remarks on result:
- other: No effect observed
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 169 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- developmental neurotoxicity
- developmental immunotoxicity
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specifiednot specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 155 mg/kg/day for male and 182 mg/kg bw for female P generation and 184 mg/kg/day for male and 169 mg/kg bw for female F1 generation when Crl:CD (Sprague-Dawley) male and female rats treated with 1,2-dichloroethane orally by drinking water.
- Executive summary:
In a Extended one generation toxicity (EOGRT) study, Crl:CD (Sprague-Dawley) male and female rats treated with 1,2-dichloroethane in the concentration of 0 (vehicle), 50, 150, and 300 mg/kg bw/day orally by drinking water as per OECD 443. Decrease in body weight and body weight gain was observed in treated rats in P generation. As EDC in drinking water to have poor palatability; drinking water consumption was generally decreased, relative to Controls, in a dose-related manner. Similarly, No effect was observed on estrous cycle, sperm evaluation, Fertility, gestation, vaginal opening and preputial separation of treated P male and female rats as compared to control. In addition, Change in relative liver weight was observed in F0 female rats. As no significant histological findings were identified in the liver (or any other tissue), the organ weight change may be considered non adverse. No gross pathological and Histopathological changes were observed in treated male and female P rats. No Reproductive/developmental effects (Cohort 1), neurodevelopmental effects (Cohort 2), and developmental immune effects (Cohort 3) were observed in F1 male and female rats. Therefore, NOAEL was considered to be 155 mg/kg/day for male and 182 mg/kg bw for female P generation and 184 mg/kg/day for male and 169 mg/kg bw for female F1 generation when Crl:CD (Sprague-Dawley) male and female rats treated with 1,2-dichloroethane orally by drinking water.
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