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EC number: 216-835-0 | CAS number: 1678-91-7
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- metabolism
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Urinary metabolism was studied in rats by GC-MS.
- GLP compliance:
- not specified
- Radiolabelling:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Weight: 307 ± 10 g
Feed: ad libitum
Drinking water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- once daily
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- 8 treated, 6 control
- Control animals:
- other: yes, water
- Positive control reference chemical:
- not required
- Details on dosing and sampling:
- Following the 14-day exposure period the rats were sacrified and histopathological examination was performed.
During the first 48 hours the rats were placed in metabolism cages and the urine collected. The samples were hydrolyzed and analysed by GC-MS. - Metabolites identified:
- yes
- Details on metabolites:
- 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol
- Conclusions:
- The urinary metabolism of ECH administered by gavage was investigated in Fischer 344 rats.
The following urinary metabolites were identified: 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol.
ECH did not undergo metabolism on the alkyl chain. Metabolism of the ring structure (dihydroxylation) was strongly favoured. Histopathological results revealed mild to moderate renal damage. - Executive summary:
The urinary metabolism of ECH administered by gavage was investigated in Fischer 344 rats.
The following urinary metabolites were identified: 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol.
ECH did not undergo metabolism on the alkyl chain. Metabolism of the ring structure (dihydroxylation) was strongly favoured. Histopathological results revealed mild to moderate renal damage.
Reference
Description of key information
Experimental data:
The urinary metabolism of ECH administered by gavage was investigated in Fischer 344 rats.
The following urinary metabolites were identified: 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol.
ECH did not undergo metabolism on the alkyl chain. Metabolism of the ring structure (dihydroxylation) was strongly favoured. Histopathological results revealed mild to moderate renal damage.
Theoretical assessment:
a) Absorption
Oral absorption:
The low molecular weight (112.22) of ECH favours absorption in the gastro-intestinal tract by
passive diffusion, however, the low water solubility (6.3 mg/L) and the high log Pow (4.56)
of ECH render absorption in the gastro-intestinal tract by passive diffusion to be unlikely. ECH may be taken up by micellular solubilisation as ECH is poorly soluble in water and has a high log Pow. Therefore, for risk assessment purposes, the oral absorption of ECH is set at 50%.
The results of the toxicity studies with ECH do not provide reason to deviate from this proposed oral absorption percentage.
Dermal absorption:
Since the log Pow is high (4.56), ECH is expected to be taken up in the stratum corneum, but
further transfer to the epidermis is predicted to be low based on the low water solubility (6.3 mg/L). Between 1-100 mg/l absorption is anticipated to be low to moderate.
In consequence, 50 % dermal absorption is proposed for ECH.
Respiratory absorption:
The low water solubility (6.3 mg/L) enhances penetration to the lower parts of the respiratory
tract. In combination with the high log Pow (4.56) ECH is expected to be taken up by
micellular solubilisation in the lower respiratory tract. For risk assessment purposes the
inhalation absorption of ECH is set at 100%.
b) Distribution
Although ECH may be expected to distribute widely throughout the body based on the small
molecular weight, the lipophilicity and low water solubility of ECH disfavour a wide distribution.
The lipophilicity of ECH also predicts that the intracellular concentration may be higher than the extracellular concentration, particularly in fatty tissues. Based on the relatively high lipophilicity ECH may accumulate. (1)
(1) Guidance for the implementation of REACH. Guidance on information requirements andchemical safety assessment. Chapter R.7c: Endpoint specific guidance. EuropeanChemical Agency, May 2008.
c) Metabolism
The urinary metabolism of ECH administered by gavage was investigated in Fischer 344 rats.
The following urinary metabolites were identified: 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol.
ECH did not undergo metabolism on the alkyl chain. Metabolism of the ring structure (dihydroxylation) was strongly favoured.
The metabolites are expected to be excreted via the urine as they are still expected to be low molecular weight compounds.
d) Excretion:
The metabolites are expected to be excreted via the urine as they are still expected to be low molecular weight compounds.
Based on the present data no further conclusions about the toxicokinetic behavior of the substance can be drawn and no further assessment is possible.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
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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