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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 261-332-1 | CAS number: 58567-11-6
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 23.5 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:
- 1 764 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 8 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation was considered unnecessary due to the low water solubility and low chemical reactivity of (ethoxymethoxy)cyclododecane and the bioavailability therefore not being higher than after oral ingestion, no inhalation study available. Corrected inhalatory NOAEC = 1000 mg/kg bw/day*(1/0.38 m3/kg/day)*(6.7 m3 (8h)/10 m3 (8h)) = 1764 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.3 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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- assumed that rat oral and dermal absorptions are equal to human oral and dermal absorption
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The long-term inhalation DNEL for systemic effects is derived from the subacute oral toxicity study (28-day study) with a NOAEL of 1000 mg/kg bw/day. The calculated DNEL is 23.5 mg/m³, applying the assessment factor of 75.
The long-term dermal DNEL for systemic effects is derived also on the basis of the subacute oral toxicity study (28-day study). For the route-to-route extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 3.3 mg/kg bw/day, applying the assessment factor of 300.
From skin sensitisation study is known that (ethoxymethoxy)cyclododecane shows sensitising properties. The long-term inhalation and dermal DNELs for local effects were not derived. A potency categorisation into medium hazard (EC3 > 2 %) applies for the neat substance or mixtures containing the substance in quantities of equal to or more than 1 %, taking into account the generic concentration limits that trigger classification of a mixture as given in Table 3.4.5 of Commission Regulation (EU) No 286/2011.
The acute/short term inhalation and dermal DNELs for local effects were not derived, since there are no quantitative data available. From skin irritation study is known that (ethoxymethoxy)cyclododecane shows irritating properties and therefore has a low hazard for local effects.
The acute/short term inhalation and dermal DNELs for systemic effects were not required, since no hazard in acute oral and dermal toxicity studies were identified (oral and dermal LD50 > 5000 mg/kg bw).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 24 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation as considered unnecessary based upon the low water solubility and low chemical reactivity of (ethoxymethoxy)cyclododecane , no inhalation study available. Corrected inhalatory NOAEC = 1000 mg/kg bw/day*(1/1.15 m3/kg/day) = 869.6 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentration
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- assumed that rat oral and dermal absorptions are equal to human oral and dermal absorptions
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
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:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route-to-route extrapolation performed
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The long-term inhalation DNEL for systemic effects is derived from the subacute oral toxicity study (28-day study) with a NOAEL of 1000 mg/kg bw/day. The calculated DNEL is 5.8 mg/m³, applying the assessment factor of 150.
The long-term dermal DNEL for systemic effects is derived also on the basis of the subacute oral toxicity study (28-day study). For the route-to-route extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 1.67 mg/kg bw/day, applying the assessment factor of 600.
The long-term oral DNEL for systemic effects is derived on the basis of the subacute oral toxicity study (28-day study) with NOAEL of 1000 mg/kg bw/day. The calculated DNEL is 1.67 mg/kg bw/day, applying the assessment factor of 600.
The long-term and short term inhalation and dermal DNELs for local effects were not derived on the basis that they were considered to present no hazard.
The acute/short term inhalation, dermal and oral DNELs for systemic effects were not required, since no hazard in acute oral and dermal toxicity studies were identified (oral and dermal LD50 > 5000 mg/kg bw).
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.
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