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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 267-029-0 | CAS number: 67762-64-5
- 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:
- 34 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:
- 2 557 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step, followed by a correction for the difference between respiratory rates of workers under standard conditions and under light activity in the second step. NAECcorr_inh = oral NOAEL (1450) x 1/0.38 m3/kg bw x 6.7 m3/10 m3 = 2557 mg/m3. As a worst case, oral absorption in rats in humans is assumed to be 100% and inhalation absorption in humans is assumed to be 100%. Therefore, correction factor for differences in the rates of absorption for the oral and the inhalation routes in rats and humans is: ABS rat-oral/ABS human-inhalation = 100/100 = 1. Therefore, NAECcorr_inh = 2557 x 1 = 2557 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 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:
- 1 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Assume that oral absorption in rats is 100% and that dermal absorption in humans is 100%. Therefore dose descriptor after route to route extrapolation is 1450 x 100/100 = 1450 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat = 4
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.1 mg/cm²
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effect
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effect
- AF for other interspecies differences:
- 1
- Justification:
- Likely to be a direct effect
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
There is one 28 day repeated dose oral toxicity study available aimed to characterise the potential toxic effects of read-across substance, fatty acids, C5-10, esters with pentaerythritol. A NOAEL of 1450 mg/kg bw/day was established for female rats based on the lack of toxicologically relevant effects at the highest dose tested and was selected as starting point for deriving the long-term systemic inhalation DNEL and the long-term systemic dermal DNEL. A long-term local dermal DNEL was derived based on local NOAEL of 5.7 mg/cm2 from the prenatal developmental toxicity study. Acute local DNELs (dermal and inhalation) were not derived as the substance is not classified for acute local effects. Acute systemic DNELs (dermal and inhalation) and a long-term local inhalation DNEL were not derived because the substance is not classified for acute effects and there are no data on long-term local effects of inhalation.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.4 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:
- 1 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose, the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hrs exposure of general public). NAECcorr_inh = oral NOAEL (1450) x 1/1.15 m3/kg bw = 1261 mg/m3. As a worst case, oral absorption in rats in humans is assumed to be 100% and inhalation absorption in humans is assumed to be 100%. Therefore, correction factor for differences in the rates of absorption for the oral and the inhalation routes in rats and humans is: ABS rat-oral/ABS human-inhalation = 100/100 = 1. Therefore, NAECcorr_inh = 1261 x 1 = 1261 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor of 10 for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.4 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:
- 1 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Assume that oral absorption in rats is 100% and that dermal absorption in humans is 100%. Therefore dose descriptor after route to route extrapolation is 1450 x 100/100 = 1450 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat = 4
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.57 mg/cm²
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health).
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effect
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effect
- AF for other interspecies differences:
- 1
- Justification:
- Likely to be a direct effect
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.4 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:
- 1 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not required
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Factor for allometric scaling for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There is one 28 day repeated dose oral toxicity study available aimed to characterise the potential toxic effects of read-across substance, fatty acids, C5-10, esters with pentaerythritol. A NOAEL of 1450 mg/kg bw/day was established for female rats based on the lack of toxicologically relevant effects at the highest dose tested and was selected as starting point for deriving the long-term systemic inhalation DNEL, the long-term systemic dermal DNEL and the long-term systemic oral DNEL. A long-term local dermal DNEL was derived based on local NOAEL of 5.7 mg/cm2 from the prenatal developmental toxicity study. Acute local DNELs (dermal and inhalation) were not derived as the substance is not classified for acute local effects. Acute systemic DNELs (dermal and inhalation) and a long-term local inhalation DNEL were not derived because the substance is not classified for acute effects and there are no data on long-term local effects of inhalation.
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.