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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- A STUDY OF THE MUTAGENICITY OF ANESTHETICS AND THEIR METABOLITES
- Author:
- LUCY WASKELL
- Year:
- 1 978
- Bibliographic source:
- Mutation Research, 57 (1978) 141-153
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Chloral hydrate was screened for mutagenicity in the Salmonella/rat-liver microsomal assay system developed by Dr. B. Ames et al.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
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: crystalline
- Details on test material:
- - Name of test material: 2,2,2-Trichloroethane-1,1-diol (Chloral hydrate)
- Molecular formula: C2-H3-Cl3-O2
- Molecular weight: 165.4026g/mol
- Smiles notation: C(C(O)O)(Cl)(Cl)Cl
- InChl: RNFNDJAIBTYOQL-UHFFFAOYSA-N
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 2,2,2-Trichloroethane-1,1-diol (Chloral hydrate)
- Molecular formula: C2-H3-Cl3-O2
- Molecular weight: 165.4026g/mol
- Smiles notation: C(C(O)O)(Cl)(Cl)Cl
- InChl: RNFNDJAIBTYOQL-UHFFFAOYSA-N
- Substance type: Organic
- Physical state: Solid
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA 100 and TA 1535
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver microsomal S9 metabolic activation system.
- Test concentrations with justification for top dose:
- 0.5 - 10 mg (maximum non-toxic dose)
- Vehicle / solvent:
- not specified
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Bacteria 0.1 ml of a stationary culture of Salmonella typhimurium strains in broth, 60 ƛ of microsomes and a NADPH-generating system (5 µmoles glucose 6-phosphate, 4 µmoles NADP, 1 unit glucose-6-phosphate dehydrogenase) were mixed in a final volume of 1 ml in either 0.1 M sodium phosphate buffer, pH 7.4 or 0.05 M Tris-HCl buffer pH 7.4 at 37°C. The anesthetic concentration in the final reaction mix was 2 mM. This reaction mixture was incubated in a sealed 5-ml vial for 30 min at 37°C before being added to the top agar and plated.
- Rationale for test conditions:
- not specified
- Evaluation criteria:
- Number of his+ revertants above control
- Statistics:
- Student’s t test
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 98 and TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Chloral hydrate was determined to induce mutations in Salmonella typhimurium TA 100 whwereas unable to induce in strains TA 98 and TA 1535 with and without rat liver microsomal S9 metabolic activation system.
- Executive summary:
Chloral hydrate was screened for mutagenicity in the Salmonella/rat-liver microsomal assay system developed by Dr. B. Ames et.al. (Standard plate incorporation assay of Ames test). The study was performed using Salmonella typhimurium strains TA98, TA100 and TA1535 in the presence and absence of rat liver microsomal S9 metabolic activation system. The test chemical was used at dose levels of 0.5 to 10 mg/plate. The number of his+ revertants above control was evaluated for each strain. The test material did not exhibit induction of his+ revertants in Salmonella typhimurium TA98 and TA1535, either with or without rat liver microsomal S9 metabolic activation system. While in strain TA100 it did induces the number of revertants with statistically significant result by Student’s t test with p values of <0.01, both with and without metabolic activation system.
Thus the substance Chloral hydrate is determined to be ambiguous in nature for in vitro genetic toxicity test.
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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