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EC number: 204-661-8 | CAS number: 123-91-1
- 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 cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method:
- according to Butterworth, B.E. et al. (1987). A protocol and guide for the in vivo rat hepatocyte DNA repair assay. Mutation Research 189, 123-133 (hepatocyte DNA-repair assay)
- according to Bermudez and Allen (1984). The assessment of DNA damage and repair in rat nasal epithelial cells. Carcinogenesis 5: 1453-1458 (respiratory epithelial cells assay) - GLP compliance:
- not specified
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- 1,4-dioxane
- EC Number:
- 204-661-8
- EC Name:
- 1,4-dioxane
- Cas Number:
- 123-91-1
- Molecular formula:
- C4H8O2
- IUPAC Name:
- 1,4-dioxane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Lab. Inc. Raleigh NY
- Age at study initiation: 10-12 weeks
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72+/- 2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- other: oral: drinking water in combination with gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- - liver hepatocytes: a single application of 1000 mg/kg bw or treatment with 1% 1,4-dioxane in drinking water for 2 weeks or treatment with 2% 1,4-dioxane for 1 week
- respiratory epithelial cells: 1% 1,4-dioxane in drinking water for 8 days, or 1% in drinking water for 8 days with an additional single gavage dose of 0, 10, 100 and 1000 mg/kg 12 h prior to sacrifice - Frequency of treatment:
- continuous and once by gavage
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- 1% in drinking water with an additional single gavage
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Remarks:
- 1% in drinking water with an additional single gavage
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Remarks:
- 1% in drinking water with an additional single gavage
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- 1% in drinking water with an additional single gavage
- Dose / conc.:
- 1 other: %
- Remarks:
- concentration in drinking water
- Dose / conc.:
- 2 other: %
- Remarks:
- concentration in drinking water
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- - hepatocyte DNA repair assay: DMN and 2-AAF
- nasal epithelial cell DNA repair assay: MMS
Examinations
- Tissues and cell types examined:
- liver hepatocytes and nasal epithelial cells
- Evaluation criteria:
- Labelled cells were recognized by by the dense pattern of silver grains overlying the nuclei, cells with a nuclei density of >= 10 were scored as undergoing replicative DNA-synthesis. The labeling index(LI) was calculated by dividing the number of labeled nuclei by the total counted.
The autoradiograms were stained and scored for the number of grains over the nucleus for 100 cells. - Statistics:
- for the hepatocytes : P <= 0.05 by the Newman-Keuls multicomparison test.
for the nasal epithelium: unpaired t-test at significance level of P<= 0.05
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Neither a single application of 1000 mg/kg bw, nor treatment with 1% 1,4-dioxane in drinking water for 2 weeks or with 2% 1,4-dioxane for 1 week, induced unscheduled DNA synthesis in primary rat hepatocytes. Negative results for unscheduled DNA synthesis were also found in rat nasal respiratory epithelial cells (from the nasoturbinate or the maxilloturbinate) after treatment of rats with 1% 1,4-dioxane in drinking water for 8 days, or after treatment with 1% in the drinking water for 8 days with an additional single gavage dose of up to 1000 mg/kg bw 1,4-dioxane.
Applicant's summary and conclusion
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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