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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-338-8 | CAS number: -
- 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:
- 21.16 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 528.95 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Theoretical inhalation DNEL only. Route-to-route extrapolation is not technically valid due to rapid hydrolysis of the anhydride moiety in aqueous body fluids, and a low vapour pressure suggesting that inhalation is not a realistic route of exposure.
- AF for dose response relationship:
- 1
- Justification:
- Dose-response is exhibited in repeated dose toxicity testing
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90-day) to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- accounted for in modification of starting dose descriptor
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic (remainder)
- AF for intraspecies differences:
- 5
- Justification:
- individual variability among workers
- AF for the quality of the whole database:
- 1
- Justification:
- adequate data on analogues
- AF for remaining uncertainties:
- 1
- Justification:
- Uncertainty accounted for by other assessment factors
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 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal DNEL is considered equivalent to an oral DNEL, assuming skin absorption is 100% of oral absorption
- AF for dose response relationship:
- 1
- Justification:
- A dose response is demonstrated in repeated dose toxicity testing
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90-day) to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic (remainder)
- AF for intraspecies differences:
- 5
- Justification:
- individual variability among workers
- AF for the quality of the whole database:
- 1
- Justification:
- adequate for analogues
- AF for remaining uncertainties:
- 1
- Justification:
- Uncertainty is accommodated by other AF
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Information on repeated dose toxicity testing is from the substance 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivatives, CAS 68784-12-3, a mixture of a hexadecenyl- and octadecenyl succinic anhydride, as part of an analogue approach. The data is informative for evaluation of the toxicity of n-ODSA EC 701-338-8, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.
The DNELs were calculated with a starting 90-day repeated oral dose NOAEL in rats of 300 mg/kg bw/d (Harlan, 2014). Assessment factors were applied as per ECHA, 2015.
Regarding local inhalation effects, respiratory irritation or sensitisation is a theoretical risk, but there is no known evidence from human workplaces for local respiratory effects. Low vapour pressure of C15-20 ASAs makes a respiratory toxicity a negligible risk.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- 1.5 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route-to-route extrapolation done
- AF for dose response relationship:
- 1
- Justification:
- displays dose-response in repeated dose studies
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90-day) to chronice
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic
- AF for intraspecies differences:
- 10
- Justification:
- individual variability
- AF for the quality of the whole database:
- 1
- Justification:
- adequate data for category
- AF for remaining uncertainties:
- 1
- Justification:
- Uncertainty accommodated by other AF
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
An oral DNEL for consumers is calculated for exposure of man via the environment. Information on repeated dose toxicity testing is from the substance 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivatives, CAS 68784-12-3, a mixture of a hexadecenyl- and octadecenyl succinic anhydride, as part of an analogue approach. The data is informative for evaluation of the toxicity of n-ODSA EC 701-338-8, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.
The DNEL was calculated with a starting 90-day repeated oral dose NOAEL in rats of 300 mg/kg bw/d (Harlan, 2014). Assessment factors were applied as per ECHA, 2015.
There are no known consumer exposures. Exposure of the general population via the environment includes large dilution factors for the inhalation and dermal routes of exposure. There is a low probability of exposure and hazard.
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.