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EC number: 251-649-3 | CAS number: 33704-61-9
- 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:
- 11 April, 1985 - 29 April 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- 1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one
- EC Number:
- 251-649-3
- EC Name:
- 1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one
- Cas Number:
- 33704-61-9
- Molecular formula:
- C14H22O
- IUPAC Name:
- 1,1,2,3,3-pentamethyl-2,3,4,5,6,7-hexahydro-1H-inden-4-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Labs, Wilmington, Massachusetts
- Weight at study initiation: 150 - 280 grams
- Fasting period before study: 18 hours
- Housing: Individually in stainless steel wire mesh cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 C +/- 3 C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.25% methylcellulose
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg
DOSAGE PREPARATION (if unusual):
Dose level 2000 mg/kg: 6.0 grams test substance in final volume of 15 ml
Dose level 3200 mg/kg: 9.6 grams test substance in final volume of 15 ml
Dose level 4000 mg/kg: dosed as received
Dose level 5000 mg/kg: dosed as received - Doses:
- 2000, 3200, 4000, and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose (10 animals per dose group)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: fourteen days
- Frequency of observations and weighing: Immediately, one and four hours after dosing, and twice daily for 14 days thereafter
- Necropsy of survivors performed: yes, gross necropsy
- Other examinations performed: clinical signs, body weight, central nervous sytem (CNS) effects, mortality, gross necropsy - Statistics:
- By the method of Litchfield and Wilcoxon, JPET 966: 99-114 (1949)
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 685 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 043 - < 3 529
- Mortality:
- 2000 mg/kg: 0/5 males died and 1/5 females died
3200 mg/kg: 2/5 males died and 3/5 females died
4000 mg/kg: 4/5 males died and 5/5 females died
5000 mg/kg: 5/5 males died and 5/5 females died
Mortality occured at day 1, day 2 and day 3. - Clinical signs:
- other: Decreased activity, diarrhea, salivation, lacrimation, ptosis, poor grooming, piloerection, decreased or increased muscle tone, abnormal stance, abnormal gait, dyspnea, tremors, convulsions, wet pelage (ventral surface), red discoloration (ventral surface
- Gross pathology:
- Necropsy of animals dying on study revealed: hemorrhagic lungs, discolored and fluid-filled intestines, distended stomachs and multiple lesions in the stomachs.
- Other findings:
- Necropsy showed non-descended testes in one animal.
No visible lesions were observed at terminal necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: not harmful in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance has an LD50 of > 2685 mg/kg bw in an OECD TG 401 test
- Executive summary:
In an acute oral toxicity study (OECD TG 401), four groups of ten rats (five males and five females) were administered the test substance (test article 85-206-02) at dose levels of 2000, 3200, 4000 and 5000 mg/kg bw. The rats showed decreased activity, diarrhea, salivation, lacrimation, ptosis, poor grooming, piloerection, decreased or increased muscle tone, abnormal stance, abnormal gait, dyspnea, tremors, convulsions, wet pelage (ventral surface), red discoloration, writhing and prostration. 1 of 10 rats died at 2000 mg/kg, 5 of 10 died at 3200 mg/kg, 9 of 10 died at 4000 mg/kg and 10 of 10 died at 5000 mg/kg. Necropsy of the animals dying on the study revealed hemorrhagic lungs, discolored and fluid-filled intestines, distended stomachs and multiple lesions in the stomachs. The acute oral LD50 for the test substance in male and female rats was determined to be 2901 mg/kg bw with 95% CI of 2325 - 3619 mg/kg bw. The calculated LD50 for males was 3380 mg/kg bw (95% CI: 2907 - 3930 mg/kg bw). The calculated oral LD50 for females was 2685 mg/kg bw (95% CI: 2043 - 3529 mg/kg bw).
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