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EC number: 946-886-0 | 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
- Study period:
- 04-19 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 13 September 2013
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (αS,1R)-α-3,3-trimethyl-cyclohexanemethanol
- Cas Number:
- 49817-42-7
- Molecular formula:
- C10H20O
- IUPAC Name:
- (αS,1R)-α-3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (αR,1S)-α-3,3-trimethyl-cyclohexanemethanol
- Cas Number:
- 49817-52-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- (αR,1S)-α-3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (1R-trans)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-55-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1R-trans)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- (1S-trans)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-44-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1S-trans)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- (R*,R*)-α,3,3-trimethyl-cyclohexanemethanol
- Molecular formula:
- C10H20O
- IUPAC Name:
- (R*,R*)-α,3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (S*,S*)-α-3,3-trimethyl-cyclohexanemethanol
- Molecular formula:
- C10H20O
- IUPAC Name:
- (S*,S*)-α-3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (1R-cis)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-43-8
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1R-cis)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- (1S-cis)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-56-3
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1S-cis)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- Non identified impurities
- Molecular formula:
- Not applicable
- IUPAC Name:
- Non identified impurities
- Test material form:
- liquid
- Details on test material:
- Batch No.: MP60-16/12/2013
Purity: 71.6% (sum of the two main constituents)
Name of test material (as cited in study report): α-3,3-TRIMETHYLCYCLOHEXANEMETHANOL MULTICONSTITUENT
Physical state: colourless to slightly yellow liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 17 December 2013
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest-St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 187-195 g
- Fasting period before study: Food was removed on Day 1 and then redistributed 4 h after administration of the test item.
- Housing: Animals were housed by group of three in solid bottomed clear polycarbonate cages with stainless steel mesh lid.
- Diet: Foodstuff (SAFE, A04), ad libitum
- Water: Drinking water (tap water from public distribution system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately 13 changes/h
- Photoperiod: 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.21 mL/kg bw
DOSAGE PREPARATION:
- In the first and second step of the study, the test item was administered by gavage under a volume of 2.21 mL/kg bw (corresponding to 2000 mg/kg bw according to the density of 0.903) using a suitable syringe graduated fitted with an oesophageal metal canula. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed for any behavioural or toxic effects at 30 minutes, 1, 3, 4, 24 and 48 h after administration of the item and continued during 14 days following the administration of test item.
Bodyweight: Animals were weighed on Days 0 (just before administering the test item), 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anesthetized with sodium pentobarbital and administration continued to fatal levels and macroscopic examination was performed. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not Applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- An absence or decrease in spontaneous activity (6/6), in muscle tone (3/6) and in righting reflex (2/6), bradypnea (1/6), staggering gait (5/6) and myosis (6/6) were noted during the first hours of the test. The animals recovered a normal behaviour at 24 h pot-dose.
- Body weight:
- The body weight evolution remained normal during the study, compared to the historical control group.
- Gross pathology:
- No macroscopic abnormalities were observed at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 for α-3,3-trimethylcyclohexanemethanol multiconstituent is higher than 2000 mg/kg bw in female rats. Therefore it is not classified according to CLP Regulation (EC) No 1272/2008.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, groups (6 female rats/dose) of Sprague Dawley rats were given a single oral (gavage) dose of α-3,3-trimethylcyclohexanemethanol multiconstiuent at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
No mortality and no clinical signs were observed. Body weight gain of the treated animals was not affected by the test item. No macroscopic abnormalities were observed at necropsy. In this study, the oral LD50 of the test item was considered to be higher than 2000 mg/kg bw in female rats.
Therefore, the oral LD50 for the test item is higher than 2000 mg/kg bw in female rats. Therefore the substance is not classified according to CLP Regulation (EC) No 1272/2008.
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