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EC number: 607-858-0 | CAS number: 260781-16-6
- 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:
- 1993-10-25 to 1993-11-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1984
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1992-06-11
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol
- EC Number:
- 607-858-0
- Cas Number:
- 260781-16-6
- Molecular formula:
- C14H26O4
- IUPAC Name:
- 1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. five to eight weeks old
- Weight at study initiation: males: 154 - 165 g; females: 140 - 154 g
- Fasting period before study: overnight fast immediately before dosing and for approximately two hours after dosing
- Housing: housed in groups of up to five by sex in solid floor polypropylene cages furnished with woodflakes.
- Diet (ad libitum, except of fasting period): Rat and Mouse Expanded Diet No. 1
- Water (ad libitum, except of fasting period): mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 22 °C
- Relative humidity: 44 - 61 %
- Air changes: approx. 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- B.P.
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
DOSAGE PREPARATION: test material was freshly prepared as a solution at the appropriate concentrations in the vehicle - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
death and overt signs of toxicity: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
individual bodyweights: prior to dosing on Day 0 and on Days 7 and 14
- Necropsy of survivors performed: yes, at the end of the study the animals were sacrificed and subjected to gross pathological examination. - Statistics:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.
Results and discussion
- Preliminary study:
- A range-finding study was conducted in rats (1 male / 1 female) at a dose level of 2000 mg/kg. Death and overt signs of toxicity were recorded 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days. Individual body weights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.
There were no deaths or clinical signs of toxicity.
Based on this results, a dose level of 2000 mg/kg bw was selected for the main study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Ataxia was noted in two males two and four hours after dosing. All other animals appeared normal throughout the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (male and female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route. - Executive summary:
The acute oral toxicity of the substance was investigated according to the OECD guideline 401 (1987). Five male and five female Sprague-Dawley rats received a single dose of 2000 mg/kg bw in arachis oil B.P. by gavage. Clinical signs, mortality, and body weight were recorded. All animals were subjected to gross necropsy.
Mortality or abnormalities at necropsy were not observed during the study. Ataxia was noted in two males two and four hours after dosing. All other animals appeared normal throughout the study. Lastly, all animals showed expected gain in body weight during the study.
Thus, the LD50 was considered to be greater than 2000 mg/kg bw for male and female rats. According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.
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