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Diss Factsheets
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EC number: 915-617-9 | CAS number: -
- 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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde
- EC Number:
- 915-617-9
- Molecular formula:
- C13H22O2
- IUPAC Name:
- Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde
- Test material form:
- liquid
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: Blue Spruce Farms, Altamont, New York
- Weight at study initiation: 180 - 280 g (after fasting)
- Fasting period before study: 18 hours
- Housing: individually in stainless steel 1/2 inch wire mesh cages
- Diet: Wayne Lab Blox, ad libitum
- Water: fresh tap water, fit for human consumption, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Rationale for the selection of the starting dose: based on the results of a dose-range finding study
- Doses:
- In the range-finding study: 0.5, 1.6 and 5 mL/kg bw.
In the main study: 4.0, 4.5, 5.0, 5.5 and 6.0 mL/kg bw. - No. of animals per sex per dose:
- In the dose-range finding study: 2
In the main study: 5 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days in the main study and 72 hours in the dose-range finding study.
- Frequency of observations and weighing: before the study (after fasting) and at day 14 in the main study and day 3 in the dose-range finding study.
- Necropsy of survivors performed: yes (in the main study).
- Other examinations performed: clinical signs, body weight.
Results and discussion
- Preliminary study:
- In the dose-range finding study, 1 of 4 rats died at 5 mL/kg bw. Clinical signs observed included decreased activity, flaccid body tone, ptosis, abnormal stance, hunched body position, red exudate around nasal area, chromodacryorrhea, pilorection and vasodilation.
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 971 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Calculated based on the relative density of 0.9941 and LD50 > 5 mL/kg bw.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 971 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Calculated based on the relative density of 0.9941 and LD50 of > 5 mL/kg bw.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 3 976 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Calculated based on the relative density of 0.9941 and LD50 of > 4 mL/kg bw
- Mortality:
- In the main study:
- 3 of 10 rats died at 4.0 mL/kg bw (2 males, 1 female) and 4.5 mL/kg bw (3 females)
- 4 of 10 rats died at 5.0 mL/kg bw (1 male, 3 females and 5.5 mL/kg bw (1 male, 3 females)
- 5 of 10 rats died at 6 mL/kg bw (2 males, 3 females). - Clinical signs:
- other: In the main study, signs observed included ptosis, prostration, decreased activity, flaccid body tone and abnormal stance.
- Gross pathology:
- Necropsy of the animals dying on study revealed distended, fluid-filled intestines and bladder, bright red lungs and blanched adrenals. Terminal necropsy of the remaining animals revealed no visible lesions at any dose level.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not harmful
- Remarks:
- in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- In the acute oral toxicity study with rats, the LD50 was > 3976 mg/kg bw for female rats, > 4971 mg/kg bw/day for male rats and > 4971 mg/kg bw for both sexes combined.
- Executive summary:
In this oral study, performed according to a protocol similar to OECD guideline 401 and in the absence of GLP conditions, LD50 values of >3976 mg/kg bw and >4971 mg/kg bw were obtained for female and male Sprague-Dawley rats, respectively. The combined LD50 value for both sexes was >4971 mg/kg bw. The observed clinical signs included ptosis, prostration, decreased activity, flaccid body tone and abnormal stance. Necropsy of the animals dying during the study revealed distended, fluid-filled intestines and bladder, bright red lungs and blanched adrenals. Terminal necropsy of the remaining animals revealed no visible lesions at any dose level.
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