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EC number: 202-676-4 | CAS number: 98-52-2
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.76 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132.24 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC(corr) = NOAEL(oral)*(1/0.38 m³/kg/d)*ABS(oral-rat)/ABS(inh-human)*(6.7 m³ (8h)/10 m³ (8 h)) = 150 mg/kg bw/d*(1/0.38 m³/kg/d)*(0.5*1)*0.67 = 132.24 mg/m³. It is assumed, that the oral absorption rate is 50% of that of the inhalation absorption. ABS(oral-rat)=oral absorption rate in rats, ABS(inh-human)=inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on an oral 28-day study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The data base is adequate and of good quality (taking into account reliability and consistency across different studies and endpoints).
- AF for remaining uncertainties:
- 1
- Justification:
- No further remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL=oral NOAEL*ABS(oral)/ABS(dermal). On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor is introduced when performing oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on an oral 28-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The experimental animal was the rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The data base is adequate and of good quality (taking into account reliability and consistency, across different studies and endpoints).
- AF for remaining uncertainties:
- 1
- Justification:
- No further remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
In general, the calculation of a DNEL is based on the observed effect level which has to be modified as described in “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, November 2012). Dermal and inhalative intakes are the possible exposure routes for workers.
The establishment of a DNEL for acute toxicity for covering effects which occur after a single exposure of a few minutes up to 24 hours is unnecessary for 4-tert-butylcyclohexanol. The substance has a low vapour pressure (6 Pa at 25°C) at room temperature and as a consequence, the inhalation via vapours can be considered negligible. In addition, 4-tert-butylcyclohexanol is described as pasty or viscid and therefore the generation and inhalation of dust is unlikely. Thus, peak exposure significantly higher than the average daily exposure and the long-term DNEL are very unlikely. Thus the assessment of a hazard after short-term exposure is sufficiently covered by derivation of the DNEL for long-term exposure. Based on the available data it is not possible to derive DNELs for local effects. Irritation on eyes is the leading local health effect but does not provide dose-response data. Therefore, a qualitative assessment is conducted and appropriate risk management measures will be identified.
As starting point for derivation of the long-term DNELs, a NOAEL of 150 mg/kg bw/day (for systemic effects) was used which was found in a subacute toxicity study performed according to OECD guideline 407 (98-0184-DGT). In this GLP Guideline study 4-tert-butylcyclohexanol was administered via gavage at concentrations of 50, 150 and 300 mg/kg bw/day for 28 days. A NOAEL of 150 mg/kg bw/day was set based on clinical symptoms, effects on motoractivity and body weight. This NOAEL was selected as relevant dose descriptor.
Inhalation
For calculation of the DNEL for long-term inhalative systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation.
It is assumed, that the oral absorption rate is 50% of that of the inhalation absorption.
Besides this, the interspecies difference between rat and human has to be taken into account. Therefore, the no observed adverse effect level has to be corrected by 6.7 / 0.38*10 regarding breathing volume and frequency. Thus, the corrected starting point for workers was 132.24 mg/m³/day for inhalation.
Subsequently assessment factors (AF) are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), duration extrapolation: subacute - chronic (6).
The DNEL is calculated according to the formula DNEL = (corrected starting point) / (overall AF). Thus, the resulting DNEL for long-term inhalative systemic effects is 1.76 mg/m³ for workers.
Dermal
For calculation of the DNEL for long-term dermal systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor is introduced when performing oral-to-dermal extrapolation. This is supported by the skin absorption potential of 0.010 mg/cm²/h for 4-tert-butylcyclohexanol, which is assigned to a high dermal absorption rate of 80% (for details refer to IUCLID chapter 7.1 toxicokinetics, metabolism and distribution). Thus, the corrected starting point for workers was 150 mg/kg bw/day for the dermal route.
Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (5) and duration extrapolation: subacute - chronic (6).
As a consequence, the resulting DNEL for long-term dermal systemic effects is 0.5 mg/kg bw/day for workers.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
4-tert-Butylcyclohexanol is only handled in industrial or professional settings (for details refer to IUCLID section 3.5 or to CSR section 2). Since exposure of the general public is precluded, DNELs for the general population are not relevant and thus not derived.
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