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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-334-1 | CAS number: 154565-28-3
- 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:
- 24 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance [2,3-epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol]. A corrected inhalation starting point (NOAEC) for workers is calculated by taking into account activity (*6.7/10) and breathing rate (/0.38); a corrected inhalation NOAEC of 1763 mg/m3 is therefore calculated. Based on the expert toxicokinetic assessment, the extent of inhalation and oral absorption is likely to be very low and considered to be equivalent.
- AF for dose response relationship:
- 1
- Justification:
- A default assessment factor of 1 is used for dose-response relationship; the starting point is derived from a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- An assessment factor of 6 is used to account for differences in the duration of exposure; extrapolation from a sub-acute study to long-term exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- An assessment factor for interspecies differences (allometric scaling) is not required; allometric factors are taken into account in derivation of the corrected (inhalation) starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default assessment factor of 2.5 is used to account for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- A default assessment factor of 5 is used to account for intraspecies differences (workers).
- AF for the quality of the whole database:
- 1
- Justification:
- A default assessment factor of 1 is used for database quality; the toxicological dataset is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- A default assessment factor of 1 is used as there are no significant remaining uncertainties.
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:
- 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance [2,3-epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol]. Based on the expert toxicokinetic assessment, the extent of dermal and oral absorption is likely to be very low and considered to be equivalent. A corrected (dermal) NOAEL of 1000 mg/kg bw/d is therefore calculated.
- AF for dose response relationship:
- 1
- Justification:
- A default assessment factor of 1 is used for dose-response relationship; the starting point is derived from a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- An assessment factor of 6 is used to account for differences in the duration of exposure; extrapolation from a sub-acute study to long-term exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default assessment factor of 4 is used to account for interspecies differences (allometric scaling); the starting point is derived from a rat study.
- AF for other interspecies differences:
- 1
- Justification:
- A default assessment factor of 2.5 is used to account for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- A default assessment factor of 5 is used to account for intraspecies differences (workers).
- AF for the quality of the whole database:
- 1
- Justification:
- A default assessment factor of 1 is used for database quality; the toxicological dataset is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- A default assessment factor of 1 is used as there are no significant remaining uncertainties.
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The submission substance [2,3-epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2 -dicarboxylic anhydride and propylidenetrimethanol] is of low acute oral toxicity, is not a skin or eye irritant or a skin sensitiser. The substance is not genotoxic and is of low repeated dose toxicity; a NOAEL of 1000 mg/kg bw/d is reported for an OECD 422 screening study. The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d.
Inhalation DNELs
Systemic inhalation DNELs
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance. A corrected inhalation starting point (NOAEC) for workers is calculated by taking into account activity (*6.7/10) and breathing rate (/0.38); a corrected inhalation NOAEC of 1763 mg/m3 is therefore calculated. Based on the expert toxicokinetic assessment, the extent of inhalation and oral absorption is likely to be very low and considered to be equivalent. Individual assessment factors of 1 (for dose-response relationship), 6 (for exposure duration), 1 (for allometric scaling), 2.5 (for interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 75. Application of the overall assessment factor of 75 to the corrected inhalation NOAEC of 1763 mg/m3 results in a long-term systemic inhalation DNEL for workers of 24 mg/m3.
The submission substance is of low acute toxicity and does not require classification for acute oral toxicity. In the absence of any identified hazard, a short-term systemic inhalation DNEL is not derived for workers.
Local inhalation DNELs
There are no data on acute or repeated inhalation exposure for the submission substance; however the submission substance is not a skin or eye irritant and is therefore not predicted to be a respiratory irritant. In the absence of any identified hazard, long-term and short-term local inhalation DNELs are not derived for workers.
Dermal DNELs
Systemic dermal DNELs
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance. Based on the expert toxicokinetic assessment, the extent of dermal and oral absorption is likely to be very low and considered to be equivalent. A corrected (dermal) NOAEL of 1000 mg/kg bw/d is therefore calculated. Individual assessment factors of 1 (for dose-response relationship), 6 (for exposure duration), 4 (for allometric scaling), 2.5 (for interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 300. Application of the overall assessment factor of 300 to the corrected dermal NOAEL of 1000 mg/kg bw/d results in a long-term systemic dermal DNEL for workers of 3.3 mg/kg bw/d.
The submission substance is of low acute oral toxicity and does not require classification for acute toxicity. In the absence of any identified hazard, a short-term systemic dermal DNEL is not derived for workers.
Local dermal DNELs
The submission substance is not a skin irritant or sensitiser. In the absence of any identified hazard, long-term and short-term local dermal DNELs are not derived for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute screening study of 1000 mg/kg bw/d with the submission substance [2,3-epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol]. A corrected inhalation starting point (NOAEC) for the general population is calculated by taking into account activity breathing rate (/1.15); a corrected inhalation NOAEC of 870 mg/m3 is therefore calculated. Based on the expert toxicokinetic assessment, the extent of inhalation and oral absorption is likely to be very low and considered to be equivalent.
- AF for dose response relationship:
- 1
- Justification:
- A default assessment factor of 1 is used for dose-response relationship; the starting point is derived from a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- An assessment factor of 6 is used to account for differences in the duration of exposure; extrapolation from a sub-acute study to long-term exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- An assessment factor for interspecies differences (allometric scaling) is not required; allometric factors are taken into account in derivation of the corrected (inhalation) starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default assessment factor of 2.5 is used to account for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- A default assessment factor of 10 is used to account for intraspecies differences (general population).
- AF for the quality of the whole database:
- 1
- Justification:
- A default assessment factor of 1 is used for database quality; the toxicological dataset is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- A default assessment factor of 1 is used as there are no significant remaining uncertainties.
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:
- 1.7 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance [2,3-epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol]. Based on the expert toxicokinetic assessment, the extent of dermal and oral absorption is likely to be very low and considered to be equivalent. A corrected (dermal) NOAEL of 1000 mg/kg bw/d is therefore calculated.
- AF for dose response relationship:
- 1
- Justification:
- A default assessment factor of 1 is used for dose-response relationship; the starting point is derived from a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- An assessment factor of 6 is used to account for differences in the duration of exposure; extrapolation from a sub-acute study to long-term exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default assessment factor of 4 is used to account for interspecies differences (allometric scaling); the starting point is derived from a rat study.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default assessment factor of 2.5 is used to account for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- A default assessment factor of 10 is used to account for intraspecies differences (general population).
- AF for the quality of the whole database:
- 1
- Justification:
- A default assessment factor of 1 is used for database quality; the toxicological dataset is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- A default assessment factor of 1 is used as there are no significant remaining uncertainties.
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point is from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance [2,3-epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] and does not therefore require correction.
- AF for dose response relationship:
- 1
- Justification:
- A default assessment factor of 1 is used for dose-response relationship; the starting point is derived from a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- An assessment factor of 6 is used to account for differences in the duration of exposure; extrapolation from a sub-acute study to long-term exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default assessment factor of 4 is used to account for interspecies differences (allometric scaling); the starting point is derived from a rat study.
- AF for other interspecies differences:
- 2.5
- Justification:
- A default assessment factor of 2.5 is used to account for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- A default assessment factor of 10 is used to account for intraspecies differences (general population).
- AF for the quality of the whole database:
- 1
- Justification:
- A default assessment factor of 1 is used for database quality; the toxicological dataset is of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- A default assessment factor of 1 is used as there are no significant remaining uncertainties.
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
The submission substance [2,3-epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2 -dicarboxylic anhydride and propylidenetrimethanol] is of low acute oral toxicity, is not a skin or eye irritant or a skin sensitiser. The substance is not genotoxic and is of low repeated dose toxicity; a NOAEL of 1000 mg/kg bw/d is reported for an OECD 422 screening study. The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d.
Inhalation DNELs
Systemic inhalation DNELs
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance. A corrected inhalation starting point (NOAEC) for the general population is calculated by taking into and breathing rate (/1.15); a corrected inhalation NOAEC of 870 mg/m3 is therefore calculated. Based on the expert toxicokinetic assessment, the extent of inhalation and oral absorption is likely to be very low and considered to be equivalent. Individual assessment factors of 1 (for dose-response relationship), 6 (for exposure duration), 1 (for allometric scaling), 2.5 (for interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 150. Application of the overall assessment factor of 150 to the corrected inhalation NOAEC of 870 mg/m3 results in a long-term systemic inhalation DNEL for the general population of 6 mg/m3.
The submission substance is of low acute toxicity and does not require classification for acute oral toxicity. In the absence of any identified hazard, a short-term systemic inhalation DNEL is not derived for the general population.
Local inhalation DNELs
There are no data on acute or repeated inhalation exposure for the submission substance; however the submission substance is not a skin or eye irritant and is therefore not predicted to be a respiratory irritant. In the absence of any identified hazard, long-term and short-term local inhalation DNELs are not derived for the general population.
Dermal DNELs
Systemic dermal DNELs
The starting point for DNEL derivation is the NOAEL from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance. Based on the expert toxicokinetic assessment, the extent of dermal and oral absorption is likely to be very low and considered to be equivalent. A corrected (dermal) NOAEL of 1000 mg/kg bw/d is therefore calculated. Individual assessment factors of 1 (for dose-response relationship), 6 (for exposure duration), 4 (for allometric scaling), 2.5 (for interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 600. Application of the overall assessment factor of 300 to the corrected dermal NOAEL of 1000 mg/kg bw/d results in a long-term systemic dermal DNEL for the general population of 1.7 mg/kg bw/d.
The submission substance is of low acute oral toxicity and does not require classification for acute toxicity. In the absence of any identified hazard, a short-term systemic dermal DNEL is not derived for the general population.
Local dermal DNELs
The submission substance is not a skin irritant or sensitiser. In the absence of any identified hazard, long-term and short-term local dermal DNELs are not derived for the general population.
Oral DNELs
Systemic oral DNELs
The starting point is from the oral (sub-acute) screening study of 1000 mg/kg bw/d with the submission substance and does not therefore require correction.
Individual assessment factors of 1 (for dose-response relationship), 6 (for exposure duration), 4 (for allometric scaling), 2.5 (for interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) are combined to give an overall assessment factor of 600. Application of the overall assessment factor of 600 to the oral NOAEL of 1000 mg/kg bw/d results in a long-term systemic oral DNEL for the general population of 1.7 mg/kg bw/d.
The submission substance is of low acute oral toxicity and does not require classification for acute toxicity. In the absence of any identified hazard, a short-term
systemic oral DNEL is not derived for the general population.
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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