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EC number: 412-450-9 | CAS number: 131766-73-9 CLARYCET
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducting according to OECD method by a GLP accredited laboratory.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- EEC Directive 84/449/EEC (OJ No. L251, 19.09.84), Part B, Method B1
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- EC Number:
- 412-450-9
- EC Name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- Cas Number:
- 131766-73-9
- Molecular formula:
- C11H20O3
- IUPAC Name:
- reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Groups of 10 Sprague-Dawley rats (Crl CD (SD) BR VAF plus strain) aged 4-6 weeks and weighing 108-152 g. The animal room temperature was 21-23°C with a mean relative humidity of 57% and a light photoperiod of 12 hours. The rats were housed in groups (up to 5 rats) by sex, were fed a standard rat diet, received water ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The rats were fasted overnight and gavaged with a single dose of undiluted test substance. Initially, only the mid-dose group was treated; however, based on the findings, the low- and high-dose groups were treated about one week later.
- Doses:
- 3.2, 5.0, or 8.0 g/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- The rats were observed up to 14 days following treatment and at frequent intervals on day 1 (day of dosing) and twice daily thereafter for clinical signs which were recorded. Body weights were recorded on days 1, 8, and 15. All rats surviving to the end of the observation period were killed on day 15 by cervical dislocation and examined macroscopically (i.e., opening of the abdominal and thoracic cavities).
- Statistics:
- The LD50 was calculated using probit analysis.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 800 - < 6 100
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 700 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 200 - < 7 000
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 300 - < 5 800
- Mortality:
- 3.2 g/kg bw: male: 3 of 5 deaths, female: 2 of 5 deaths. Rats died within 2 days.
5.0 g/kg bw: male: 2 of 5 deaths, female: 2 of 5 deaths. Rats died within 2 days.
8.0 g/kg bw: 10/10 deaths, all rats died within 2-4 days. - Clinical signs:
- other: Pilo-erection and abnormal body carriage (hunched posture) were observed in all rats within 5 minutes of dosing, and were accompanied at this time by increased salivation in rats dosed at 5 g/kg plus abnormal gait (waddling) and lethargy in rats treated a
- Gross pathology:
- Terminal autopsy showed no macroscopic abnormalities at all dose levels.
Post mortem examination of rats that died during the study revealed no macroscopic abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance does not require labeling with the risk phrase Risk phrase R22 (DSD) or H-statement H302 (CLP) “Harmful if swallowed”
- Executive summary:
The test substance was administered by oral gavage at a dose level of 3.2, 5.0, or 8.0 g/kg body weight. Animals were observed twice daily and their body weights were weekly recorded. Macroscopic examination was performed after sacrifice.
Mortality occurred at all dose levels. Clinical signs included piloerection, hunched posture, waddling, lethargy, decreased respiratory rate, ptosis, pallor of extremities, prostration, increased salivation, and increased lacrimation.
The body weight gain of the surviving animals was normal.
No abnormalities were found at post mortem examinations of the animals.
The LD50 of the test substance is 4500 mg/kg body weight. Consequently, the test substance does not need to be classified according to Regulation (EC) 1272/2008 on acute toxicity.
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