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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 263-061-4 | CAS number: 61789-45-5
- 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:
- 17.632 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.6 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)) = 1000 mg/kg bw/d*(1/0.38 m³/kg/d)*(0.5*1)*0.67 = 881.6 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:
- 4
- Justification:
- DNEL is based on an OECD 422 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 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:
- 10 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL = oral NOAEL*ABS(oral)/ABS(dermal) = 1000 mg/kg bw/day*(1/0.5) = 2000 mg/kg bw/day. Based on a moderate dermal absorption the absorption difference for the dermal route compared to the oral route is adjusted by the factor 0.5.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 4
- Justification:
- DNEL is based on an OECD 422 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 remaining uncertainties.
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:
- 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:
- no hazard identified
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, May 2012).
Long-term dermal and inhalative intakes are the possible exposure routes for workers, whereas oral, dermal and inhalative intakes are the possible exposure routes for the general population. In regard to acute and long-term systemic effects no hazard was identified for the fatty acids category members based on the available data. Considering acute and long-term local effects, no local irritation on skin and/or mucous membranes are expected for fatty acids with a chain length > C12 with the exception of C22:1 (erucic acid).
As starting point for derivation of the DNEL, the NOAEL of 1000 mg/kg bw/day (for systemic effects) was used which was found in a study performed according to OECD 422 where the males were treated by gavage for 42 days with docosanoic acid and the females 14 days prior to mating until day 3 of lactation (Nagao et al., 2002).
A substance-specific adjustment of the NOAEL is not performed since the obtained value of 1000 mg/kg bw/day reflects the “worst case” among the available key studies for repeated dose toxicity and for toxicity on reproduction of fatty acids within the category.
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. The absorption difference for inhalation compared to the oral route is reflected by the factor 2 as suggested by the ECHA CSA Guidance Chapter R.8. Besides this, the interspecies difference between rat and human has to be taken into account. Therefore, the no observed effect level has to be corrected by the risk assessor 6.7 / 0.38*10 regarding breathing volume and frequency. Thus, the corrected starting point for workers was 881.6 mg/m³/d for inhalation.
Subsequently assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (4). An assessment factor of (4) for duration extrapolation was chosen, since in the combined repeated dose and reproductive/developmental toxicity screening test (Nagao et al., 2002) from which the NOAEL was taken as starting point, the exposure duration exceeds a subacute exposure duration of 28 days. Thus the mean value (4) of the default assessment factor (6) for an extrapolation subacute - chronic and the default assessment factor (2) for an extrapolation subchronic – chronic was considered appropriate.
The DNEL is calculated according to the equation: DNEL = (corrected starting point)/(overall AF). Thus, the resulting DNEL for long-term inhalative systemic effects is 17.632 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. The absorption difference for the dermal route compared to the oral route is adjusted by the factor 0.5 due to the skin absorption classification as moderate based on the QSAR result for hexanoic acid (Danish EPA Database, 2004). This fatty acid has the highest absorption rate among all members of the category with 0.047 mg/cm²/h reflecting the worst case for all category members. Thus the corrected starting point for workers was 2000 mg/kg bw 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), exposure duration (4).
As a consequence, the resulting DNEL for long-term dermal systemic effects is 10.0 mg/kg bw/day for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.348 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):
- 100
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC(corr) = NOAEL(oral)*(1/1.15 m³/kg/d)*ABS(oral-rat)/ABS(inh-human) = 1000 mg/kg bw/d*(1/1.15 m³/kg/d)*(0.5*1) = 434.8 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:
- 4
- Justification:
- DNEL is based on an OECD 422 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:
- 10
- Justification:
- Default value for general population 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 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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 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):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL=oral NOAEL*ABS(oral)/ABS(dermal). Based on a moderate dermal absorption the absorption difference for the dermal route compared to the oral route is adjusted by the factor 0.5.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 4
- Justification:
- DNEL is based on an OECD 422 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:
- 10
- Justification:
- Default value for general population 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 remaining uncertainties.
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:
- hazard unknown (no further information necessary)
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:
- 2.5 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):
- 400
- 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 required.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 4
- Justification:
- DNEL is based on an OECD 422 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:
- 10
- Justification:
- Default value for general population 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 remaining uncertainties.
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
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, May 2012).
Long-term dermal and inhalative intakes are the possible exposure routes for workers, whereas oral, dermal and inhalative intakes are the possible exposure routes for the general population. In regard to acute and long-term systemic effects no hazard was identified for the fatty acids category members based on the available data. Considering acute and long-term local effects, no local irritation on skin and/or mucous membranes are expected for fatty acids with a chain length > C12 with the exception of C22:1 (erucic acid).
As starting point for derivation of the DNEL, the NOAEL of 1000 mg/kg bw/day (for systemic effects) was used which was found in a study performed according to OECD 422 where the males were treated by gavage for 42 days with docosanoic acid and the females 14 days prior to mating until day 3 of lactation (Nagao et al., 2002).
A substance-specific adjustment of the NOAEL is not performed since the obtained value of 1000 mg/kg bw/day reflects the “worst case” among the available key studies for repeated dose toxicity and for toxicity on reproduction of fatty acids within the category.
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. The absorption difference for inhalation compared to the oral route is reflected by the factor 2 as suggested by the ECHA CSA Guidance Chapter R.8. Besides this, the interspecies difference between rat and human has to be taken into account. Therefore, the no observed effect level has to be corrected by the risk assessor 1/1.15 regarding breathing volume and frequency. Thus, the corrected starting point for the general population is 434.8 mg/m³/day for inhalation.
Subsequently assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (10), exposure duration (4). An assessment factor of (4) for duration extrapolation was chosen, since in the combined repeated dose and reproductive/developmental toxicity screening test (Nagao et al., 2002) from which the NOAEL was taken as starting point, the exposure duration exceeds a subacute exposure duration of 28 days. Thus a mean value of the default assessment factor (6) for an extrapolation subacute - chronic and the default assessment factor (2) for an extrapolation subchronic – chronic was considered appropriate.
The DNEL is calculated according to the equation: DNEL = (corrected starting point)/(overall AF). Thus, the resulting DNEL for long-term inhalative systemic effects is 4.348 mg/m³ for the general population.
Oral
For the DNEL of systemic oral effects a correction of the starting point is not required, since the observed effect level was derived in oral repeated dose toxicity study (Nagao et al., 2002).
Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (10), exposure duration (4). The resulting DNEL for long-term oral systemic effects is 2.5 mg/kg bw/day for the general population.
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. The absorption difference for the dermal route compared to the oral route is adjusted by the factor 0.5 due to the skin absorption classification as moderate based on the QSAR result for hexanoic acid (Danish EPA Database, 2004). This fatty acid has the highest absorption rate among all members of the category with 0.047 mg/cm²/h reflecting the worst case for all category members. Thus the corrected starting point for workers was 2000 mg/kg bw 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 (10), exposure duration (4). The resulting DNEL for long-term dermal systemic effects is 5.0 mg/kg bw/day 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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