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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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:
- Tetrahydro-4-methyl-2-propyl-2H-pyran-4-yl acetate: Mouse micronucleus test
- Year:
- 1 993
- Bibliographic source:
- Unpublished report
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- CD-1 mice (20/sex) weighing 22-24 g on receipt (acclimatized for ~4 days) were group-housed separated by sex (number per cage not stated) and given free access to Biosure LAD 1 rodent diet and drinking water. The animal room temperature was 22°C and a light photoperiod of 12 hours.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 1% methylcellulose
- Details on exposure:
- The mice were gavaged with 1600 mg test substance/kg body weight. Mice were fasted overnight prior to and for 2 hours after dosing.
- Duration of treatment / exposure:
- one dose
- Frequency of treatment:
- single dose
- Post exposure period:
- 24, 48, and 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20 ml/kg body weight
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 mice/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- A positive control group consisting of 5 mice/sex received a single dose of 12 mg/kg bw of Mitomycin C. Positive control animals were killed at 24 hours.
Examinations
- Details of tissue and slide preparation:
- Both femurs were dissected out from each animal, were cleared of tissue and the proximal epiphysis was removed from each bone. The bone marrow smears were made directly on glass microscope slides containing a drop of calf serum. One slide per femur was prepared. The smears were fixed in methanol, air-dried, stained with 10% Giemsa, rinsed with distilled water, air-dried, and mounted with coverslips using DPX.
The stained smears were examined by light microscopy to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes per mouse. The proportion of polychromatic to normochromatic erythrocytes was assessed by examination of at least 1000 erythrocytes and the number of micronucleated mature erythrocytes was recorded. - Evaluation criteria:
- A response was considered positive if there was a substantial statistically significant increase in the incidence of micronucleated immature erythrocytes compared to that of vehicle controls. Bone marrow toxicity is identified by a substantial, statistically significant decrease in the proportion of polychromatic to normochromatic erythrocytes.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- see additional information on results
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No statistically significant change in number of micronucleated polychromatic erythrocytes or micronucleated normochromatic erythrocytes at any of the 3 sampling times; a small, but statistically significant, decrease in the ratio of polychromatic to normochromatic erythrocytes compared to vehicle control (0.754 versus 1.157) seen at 72-hour sampling time but not at other 2 sampling times (1.077 at 24 hours; 0.945 at 48 hours)
Any other information on results incl. tables
The positive control caused a highly significant increase in the frequency of micronucleated polychromatic erythrocytes and did not cause any statistically significant decreases in the ratio of polychromatic to normochromatic erythrocytes.
2 male and 5 females died after dosing due to gavage error (confirmed at necropsy). These animals were replaced by the 5 additional mice per sex dosed at the same time. Clinical signs included hunched posture, increased respiratory rate, lethargy, loss of righting reflex, pilo-erection, staggering gait, and tail black at tip.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this study, the test substance did not show any evidence of causing chromosome damage when administered orally in this in vivo test procedure. - Executive summary:
The mammalian Erythrocyte Micronucleus Test according to OECD method 474 has been employed to assess the potential of the test substance to induce mutagenic effects in mice following acute oral administration. 5 groups of mice per sex per dose CD-1 mice were gavaged with 1600 mg test substance/kg, a positive control or the vehicle body weight in 1% methylcellulose at a dose volume of 20 ml/kg body weight. After sacrifice after 24, 48, and 72 hours post-dosing, the proportion of polychromatic to normochromatic erythrocytes was assessed. The test substance did not show any evidence of causing chromosome damage when administered orally in this in vivo test procedure.
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