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EC number: 947-711-0 | 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:
- from 2000-05-17 to 2000-07-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol
- EC Number:
- 947-711-0
- Molecular formula:
- C14H28O
- IUPAC Name:
- Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl : CD ® (SD) IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males - 202 to 233 g; females - 209 to 226 g
- Fasting period before study: overnight fasting right before dosing
- Housing: in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum during the study
- Water: ad libitum during the study
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- CLASS METHOD
- Rationale for the selection of the starting dose: based on available information. The testing sequence followed the flow chart described in OECD 423. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- observations: at 30 min, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
-- weighing: prior to dosing and at 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination, examination of major organs - Statistics:
- No statistical analysis was performed. The LD50 was determined from the nominal dosing level.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Diarrhoea was noted in two male animals during the day of dosing. No other adverse clinical signs were noted.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Bodyweight and bodyweight gain during the treatment and observation period
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) during Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Female 1-2 Female 1-3 Female |
216 226 209 |
246 264 240 |
262 285 261 |
30 38 31 |
16 21 21 |
2-0 Male 2-1 Male 2-3 Male |
222 233 202 |
286 299 255 |
325 367 385 |
64 66 53 |
39 68 30 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality was observed at dosing level 2000 mg/kg. The LD50 of the test item was determined to be >5000 mg/kg.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Sprague-Dawley CD strain rat. The test was performed according to OECD 423 "Acute Oral Toxicity - Acute Toxic Class Method" (1996) and Commission Directive 96/54/EC Method B1 tris. 2000 mg/kg bodyweight was selected as the starting dose. A group of three fasted females was treated with the starting dose. This was followed by a group of three fasted males at the same dose level. The test item was administered orally, undiluted. The animals were observed 30 min, 1, 2 and 4 hours after dosing and then once daily for fourteen days. Bodyweights were recorded on the day of dosing and on Days 7 and 14. At the end of the observation period all animals were killed by cervical dislocation and subjected to gross necropsy. There were no deaths during the study. Diarrhoea was noted in two male animals during the day of dosing after 2 and 4 hours. No other adverse clinical signs were noted. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral LD50 of the test item in the Sprague-Dawley rat, was estimated as being greater than 5000 mg/kg bodyweight as no mortalities were noted in animals treated with 2000 mg/kg bodyweight.
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