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Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,6R)-4,6-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,6R)-4,6-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
EC number: 700-927-7 | 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
Endpoint summary
Administrative data
Description of key information
The substance was tested in an acute oral toxicity study with Sprague-Dawley rats, performed according to OECD 401 test guideline but not under GLP. No deaths occurred. Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery was apparently complete by day 3.
Slightly low bodyweight gains were recorded on day 8 for two male and one female rat. Other rats achieved anticipated bodyweight gains throughout the study. At gross pathology no abnormalities were seen.
The LD50 of the substance was established to be >5000 mg/kg bodyweight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 22, 1987 - August 05, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD 401 Guideline, but predating GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, U.K.
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 103 - 128 g
- Fasting period before study: overnight prior to and approximately 4 hours after dosing
- Housing: Group housed per sex in metal cages with wire mesh floors
- Diet: A standard laboratory rodent diet (Labsure LAD 1) was provided ad libitum
- Water: water was provided ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 68
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5.26 mL/kg
- Doses:
- 5000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing at frequent intervals for a Day. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes, all animals were killed on day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination.
- Body weight: Day 1, 8 and 15. - Statistics:
- Not required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was apparently complete by day 3.
- Gross pathology:
- No abornormalities were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity study with rats, performed according to OECD 401 test guidelines, an LD50 >5000 mg/kg bw was determined.
- Executive summary:
The substance was tested in an acute oral toxicity study with Sprague-Dawley rats, performed according to OECD 401 test guideline, but not under GLP.
No deaths occurred. Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery was apparently complete by day 3.
Slightly low bodyweight gains were recorded on day 8 for two male and one female rat. Other rats achieved anticipated bodyweight gains throughout the study. At gross pathology no abnormalities were seen.
The LD50 of the substance was established to be >5000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The one study available is sufficiently adequate to cover this endpoint.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The one study is available is conducted according to OECD 401 guideline and is sufficiently adequate.
Justification for classification or non-classification
The substance does not have to be classified and labelled for acute oral toxicity in accordance with Regulation EC No. 1272/2008 and Directive 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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