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EC number: 238-098-4 | CAS number: 14228-73-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD TG 425, EPA OPPTS 870.1100 and in accordance with the Principles of Good Laboratory Practices (GLP).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Remarks:
- GLP characterization of 1,4-Cyclohexanedimethanol, reaction products with epichlorohydrin was carried out concurrently along with the conduct of the study, which did not have any impact on the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- same as above
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- EC Number:
- 600-447-7
- Cas Number:
- 14228-73-0
- Molecular formula:
- C14 H24 O4
- IUPAC Name:
- 1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Reference substance name:
- D.E.R.™ Epoxy Resins, POLYPOX™ Epoxy
- IUPAC Name:
- D.E.R.™ Epoxy Resins, POLYPOX™ Epoxy
- Test material form:
- other: yellow liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,4 Cyclohexanedimethanol Reaction Products with Epichlorohydrin
- Analytical purity: The purity of the test material was determined to be 9.5 area % 1,4-Cyclohexanedimethanol monoglycidiyl ether, 45.0 area %, 1,4-Cyclohexanedimethanol diglycidyl ether, and 25.0 area % of the reaction product of 1,4-cyclohexanedimethanol with 3 equivalents of epichlorohydrin by gas chromatography/flame ionization detector with tentative identification of the major components by nuclear magnetic resonance and gas chromatography mass spectrometry
- Impurities (identity and concentrations): no information available
- Lot number : Lot # 1H1050NZP1
- Expiration date of the lot/batch: March 05, 2015
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Frederick, MD
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 124-135 grams
- Fasting period before study: yes
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Harlan Teklad Certified Global 16% Protein Rodent Diet® #2016C. The diet was available ad libitum, except during fasting.
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum.
- Acclimation period: 6-34 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22ºC
- Humidity (%):30-49%,
- Air changes (per hr): 13 - 14.
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- not applicable
- Doses:
- Limit dose - 2000 mg/kg
Main test - 175, 550 and 2000 mg/kg - No. of animals per sex per dose:
- Limit test - 1 female rat
Main test - 7 additional female rats - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality, signs of gross toxicity, and behavioral changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing or until death occurred. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing or after death.
- Necropsy of survivors performed: yes - Surviving rats were euthanized via CO2 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all decedents and euthanized animals. The external surface of the body and all orifices, tissues, and organs of the thoracic and abdominal cavities were examined. - Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program (Westat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations, and/or LD50 and confidence limit calculations.
Results and discussion
- Preliminary study:
- An initial limit dose of 2,000 mg/kg was administered (undiluted, as received) to one healthy female rat by oral gavage. Due to mortality in this animal, the study proceeded to the Main Test. Using the default starting level of 175 mg/kg and following the Up and Down procedure, seven additional females were dosed at levels of 175, 550 or 2,000 mg/kg.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 098 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 550 - 2 000
- Mortality:
- 175 mg/kg (1 rat) - no mortality
550 mg/kg (3 rats) - no mortality
2000 mg/kg (4 rats) - 100% mortality - Clinical signs:
- other: 175 mg/kg and 550 mg/kg -Apart from soft feces and reduced fecal volume noted for one rat from the 550 mg/kg dose group at 3 hours or one day post-dosing, all animals from both dose levels appeared active and healthy over the 14-day observation period. Th
- Gross pathology:
- 175 mg/kg and 550 mg/kg - No gross abnormalities were noted for any of these animals when necropsied at the conclusion of the 14-day observation period.
2000 mg/kg - Gross necropsy of the decedents revealed red discoloration of the lungs or stomach and intestines and/or slight distention of the stomach. - Other findings:
- none
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of 1,4-Cyclohexanedimethanol, reaction products with epichlorohydrin (1,4-CHDM DGE) is estimated to be 1098 milligrams per kilogram of body weight (based on an assumed sigma of 0.5) in female rats with an approximate 95% confidence interval of 550 mg/kg bw (lower) to 2,000 mg/kg bw (upper). As per Guidance to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures (2012), 1,4-Cyclohexanedimethanol, reaction products with epichlorohydrin (1,4-CHDM DGE) will be classified as acutely toxic (oral), Category 4
- Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with female Fischer 344 rats to determine the potential for 1,4-Cyclohexanedimethanol, reaction products with epichlorohydrin, to produce toxicity from a single dose via the oral route. Under the conditions of this study, the acute oral LD50 of the test substance is estimated to be 1,098 mg/kg of body weight (based on an assumed sigma of 0.5) in female rats with an approximate 95% confidence interval of 550 mg/kg (lower) to 2,000 mg/kg (upper). As per Guidance to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures (2012), 1,4-Cyclohexanedimethanol, reaction products with epichlorohydrin (1,4-CHDM DGE) will be classified as acutely toxic (oral), Category 4.
An initial limit dose of 2,000 mg/kg was administered (undiluted, as received) to one healthy female rat by oral gavage. Due to mortality in this animal, the study proceeded to the Main Test. Using the default starting level of 175 mg/kg and following the Up and Down procedure, seven additional females were dosed at levels of 175, 550 or 2,000 mg/kg. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing or until death occurred. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing or after death. Necropsies were performed on all animals.
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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