Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-035-0 | CAS number: 4621-04-9
- 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:
- weight of evidence
- Study period:
- September 12, 1983 - October 20, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study meets the EC Standards (conducted equivalent to OECD 401) and performed according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
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:
- 4-isopropylcyclohexanol
- EC Number:
- 225-035-0
- EC Name:
- 4-isopropylcyclohexanol
- Cas Number:
- 4621-04-9
- Molecular formula:
- C9H18O
- IUPAC Name:
- 4-(propan-2-yl)cyclohexan-1-ol
- 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: Charles River breeding labs, Wilmington, Massachusetts
- Age at study initiation: No data
- Weight at study initiation: 180 - 280 g (after fasting)
- Fasting period before study: 18 hours
- Housing: Rats were housed individually in stainless steel wire mesh cages
- Diet: Free access to Wayne Lab Blox
- Water: Free access to fresh tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.25% Methylcellulose
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg (2000, 3200 and 5000 mg/kg) and 4 mL/kg (4000 mg/kg)
- Doses:
- Dose range finding study: 500, 1600 and 5000 mg/kg
Main study:
2000 and 3200 mg/kg test substance in 0.25% Methylcellulose
4000 and 5000 mg/kg test substance as received - No. of animals per sex per dose:
- Dose range finding study:
2 males and 2 females
Main study:
5 males and 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (pharmacotoxic and CNS effects): immediately and 1, 4 and 24 hours after dosing
- Bodyweights: on day 14
- Necropsy of survivors performed: yes - Statistics:
- Not applicable.
Results and discussion
- Preliminary study:
- Signs observed included abnormal gait, abnormal stance, piloerection, ptosis, decreased body tone, decreased activity, diarrhea, hypersensitivity, salivation, poor grooming and prostration. None of the animals died at 500 mg/kg, one of four died at 1600 mg/kg and three of four died at the 5000 mg/kg dose level.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 607 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 075 - < 3 277
- Mortality:
- Three of the rats died at 2000 mg/kg, seven died at 3200 and 4000 mg/kg and all animals died at 5000 mg/kg.
- Clinical signs:
- Signs observed included decreased activity, ataxia, diarrhea, salivation, lacrimation, ptosis, poor grooming, chromodacryorrhea, piloerection, decreased body tone, abnormal gait, abnormal stance, tremors, epistaxis, body drop, semi-prostration, prostration, dilated pupils and hypersensitivity.
- Body weight:
- All surviving animals showed a normal body weight increase.
- Gross pathology:
- Necropsy of the animals dying on study revealed hemorrhages, desquamation and ulceration of the stomach. The stomach, intestines and bladder were fluid-filled and distended. The thymus, liver and adrenals were discolored. Congested testes and mottled lungs were observed. Poor grooming and wet ventral pellage were also observed. Terminal necropsy revealed no test substance related lesions in the remaining animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- In an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline and performed according to GLP principles, an LD50 of 2607 mg/kg bw was determined.
- Executive summary:
The test substance 83 -219 -02 was tested in an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline and performed according to GLP principles.
Three of the rats died at 2000 mg/kg, seven died at 3200 and 4000 mg/kg and all animals died at 5000 mg/kg. Signs observed included decreased activity, ataxia, diarrhea, salivation, lacrimation, ptosis, poor grooming, chromodacryorrhea, piloerection, decreased body tone, abnormal gait, abnormal stance, tremors, epistaxis, body drop, semi-prostration, prostration, dilated pupils and hypersensitivity. Necropsy of the animals dying on study revealed hemorrhages, desquamation and ulceration of the stomach. The stomach, intestines and bladder were fluid-filled and distended. The thymus, liver and adrenals were discolored. Congested testes and mottled lungs were observed. Poor grooming and wet ventral pellage were also observed. Terminal necropsy revealed no test substance related lesions in the remaining animals. Based on the results, an LD50 of 2607 mg/kg bw was determined.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.