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EC number: 206-117-5 | CAS number: 302-17-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dosing for 3 days, with further 1 day before examination
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Use of standard methods recommended by OECD
Data performed as part of US National Toxicity Programme in the period up to publication in 1996
The study was performed twice.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Remarks:
- Data source claims GLP compliance, but no evidence provided by publisher of the data
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2,2,2-trichloroethane-1,1-diol
- EC Number:
- 206-117-5
- EC Name:
- 2,2,2-trichloroethane-1,1-diol
- Cas Number:
- 302-17-0
- Molecular formula:
- C2H3Cl3O2
- IUPAC Name:
- 2,2,2-trichloroethane-1,1-diol
- Test material form:
- solid: granular
Constituent 1
- Specific details on test material used for the study:
- Referred to as chloral hydrate
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Phosphate buffered saline
- Details on exposure:
- Three injections, once a day for three days
Cells were harvested 24 hours after third injection. - Duration of treatment / exposure:
- 3 days
- Frequency of treatment:
- Daily
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
Injected with 0.4 mL of phosphate-buffered saline only
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 mice per treatment per replicate
Study replicated, making total 10 mice per group (noting only 4 were used for evaluation in one negative control and one positive control) - Control animals:
- yes, concurrent vehicle
- other: Positive: cyclophosphamide
- Positive control(s):
- Cyclophosphamide
Examinations
- Tissues and cell types examined:
- Bone marrow cells (polychromatic erythrocyte, PCE)
- Details of tissue and slide preparation:
- Blood smears were prepared from bone marrow cells obtained from the femurs.
Air-dried smears were fixed and stained; 2,000 polychromatic erythrocytes (PCEs) were scored for the frequency of micronucleated
cells in each of four or five animals per dose group. - Statistics:
- Significance of micronucleated PCEs/1,000 cells PCEs was evaluated by the one-tailed trend test (ILS, 1990); significant at P#0.025
Results and discussion
Test resultsopen allclose all
- Key result
- Sex:
- male
- Genotoxicity:
- ambiguous
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The test was repeated.
Both assays resulted in slight increase in micronucleated PCEs, with the first assay just significant following statistical analysis. The second assay was negative by statistical analysis.
Any other information on results incl. tables
Male mice injected with 125 to 500 mg/kg showed a slight dose-related trend in the frequency of micronucleated erythrocytes in bone marrow sampled 24 hours after treatment
* considered significant
Dose level | No. Mice each assay | No. micronucleated PCEs First assay |
No. micronucleated PCEs Second assay |
Phosphate buffer control | 4 + 5 | 2.9 ± 0.5 | 1.7 ± 0.3 |
Positive control | 4 + 5 | 19.1 ± 2.2 | 17.4 ± 1.7 |
125 mg/kg | 5 + 5 | 2.1 ± 0.5 | 2.2 ± 0.5 |
250 mg/kg | 5 + 5 | 2.7 ± 0.6 | 2.1 ± 0.3 |
500 mg/kg | 5 + 5 | 4.4 ± 0.8* | 3.5 ± 0.5 |
Applicant's summary and conclusion
- Conclusions:
- Male mice injected with 125 to 500 mg/kg showed a slight, but statistically signigicant dose-related trend in the frequency of micronucleated erythrocytes in bone marrow sampled 24 hours after treatment in one assay, but negative in a repeated test.
- Executive summary:
The US National Toxicity Programme report concludes that mouse liver microsomes generate free radical intermediates that resulted in endogenous lipid peroxidation, forming malondialdehyde, formaldehyde, acetaldehyde, acetone, and propionaldehyde. Induction of endogenous lipid peroxidation by xenobiotics through generation of free radical species results in alterations of cellular function and genotoxic damage. It is considered by the authors likely that metabolisms of chloral hydrate following high levels of repeated exposure may lead to potentially mutagenic metabolites being formed.
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