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EC number: 259-423-6 | CAS number: 54982-83-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Range finding test yielded four doses: 3.18; 3.96; 5.0; 6.3 ml/kg;
Appraisal of the safety of foods, drugs and cosmetics (FDA) rules applied - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,4-dioxacyclohexadecane-5,16-dione
- EC Number:
- 259-423-6
- EC Name:
- 1,4-dioxacyclohexadecane-5,16-dione
- Cas Number:
- 54982-83-1
- Molecular formula:
- C14H24O4
- IUPAC Name:
- 1,4-dioxacyclohexadecane-5,16-dione
- Test material form:
- liquid
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Paderborn
- Weight at study initiation: ca. 140 g
- Fasting period before study: 16 hours before dose administration
- Diet: Standard laboratory diet (Ssniff/Intermast), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 3.18, 3.96, 5.00, and 6.30 ml/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Clinical signs were determined after 20 minutes, 3 hours, 24 hours and 7 days. Body weight was determined on day 0 and 7
- Necropsy of survivors performed: yes - Statistics:
- LD50 was determined following Litchfield and Wilcoxon with Gaussian approximation.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4.21 other: mL/kg bw (4500 mg/kg bw)
- Based on:
- test mat.
- Mortality:
- 3.18 ml/kg: 0/10
3.96 ml/kg: 4/10
5.00 ml/kg: 9/10
6.30 ml/kg: 10/10
Animals that died, died within 24 hours after test substance administration - Clinical signs:
- In the doses applied the substance did not show any toxic symptoms other than apathy of the animals after 20 minutes
- Body weight:
- Average body weights
3.18 ml/kg: 132.5g at day 0 and 150.5g at day 7
3.96 ml/kg: 136.0g at day 0 and 156.5g at day 7
5.00 ml/kg: 135.0g at day 0 and 162.0g at day 7
6.30 ml/kg: 135.0g at day 0 - Gross pathology:
- No abnormalities were found after necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: not acute harmful
- Remarks:
- according to EU CLP (EC 1272/2008 and its amendments)
- Conclusions:
- The LD50 is 4500 mg/kg bw based on a similar to OECD TG 401 study.
GHS: For GHS this substance need to be classified as Acute Tox 5 (H303) - Executive summary:
In an acute oral toxicity study conducted using a protocol similar to OECD guideline 401 (non-GLP), undiluted test substance was administered via oral gavage to fasted Wistar rats (five males + five females/dose) at dose levels of 3.18, 3.96, 5.00 and 6.30 mL/kg. The animals were sluggish soon after administration. In the higher dose groups mortality was observed within 24 hours of dosing, while no additional mortality was observed after 7 days. Necropsy did not reveal any pathological effects. The LD50 was 4.21±1 mL/kg bw (4500 mg/kg bw) both for the 24 hour and 7 day observation period.
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