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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-873-6 | CAS number: 26650-05-5
- 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
![](https://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:
- 233.36 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 20.4
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4 761 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting from a key oral OECD 422 toxicity study with read-acoss substance Butanedioic acid, 2(or 3)-
sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium
salts; no repeated dose inhalation toxicity study available.- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- Extrapolation from subacute to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 2.4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 165.44 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 81.6
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 13 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Starting from a key oral OECD 422 toxicity study with read-across substance Butanedioic acid, 2(or 3)-
sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts;
there was no repeated-dose dermal toxicity study. - AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- Extrapolation from subacute to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 2.4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Source information for DNELs:
- Key data for subacute toxicity were available from an oral (gavage) OECD 422 study in rats with read- across substance Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts, at dose levels given by oral gavage of 100, 300 and 1000 mg/kg bw/day. No relevant effects were observed at 100 and 300 mg/kg bw. At the dose of 1000 mg/kg bw, decreased body weight, increased serum ALAT and decreased serum albumin were observed as systemic changes, whereas macroscopic and microscopic stomach changes were observed as local changes, however the latter without relevance to humans. NOAEL for paternal/maternal toxicity was 300 mg/kg bw/day.
- For risk assessment, the NOAEL of 300 mg/kg bw with registered substance tested in the OECD 422 study was selected as dose descriptor for calculation of long term systemic DNELS. Further justification of assessment factors is explained in the DNEL justification document attached to the endpoint summary.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 69.05 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 34
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 348 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Starting from a key oral OECD 422 toxicity study with read-across substance Butanedioic acid, 2(or 3)-
sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts ;
there was no repeated-dose inhalation toxicity study. - AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- Extrapolation from subacute to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 99.26 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 136
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 13 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Starting from a key oral OECD 422 toxicity study with read-across substance Butanedioic acid, 2(or 3)-
sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts ;
there was no repeated-dose dermal toxicity study. - AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- Extrapolation from subacute to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 2.21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 136
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable; starting from a key oral OECD 422 toxicity study with read-across substance Butanedioic
acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters,
disodium salts. - AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- Extrapolation from subacute to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between speciees; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Source information for DNELs:
- Key data for subacute toxicity were available from an oral (gavage) OECD 422 study in rats with read- across substanceButanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts, at dose levels given by oral gavage of 100, 300 and 1000 mg/kg bw/day. No relevant effects were observed at 100 and 300 mg/kg bw. At the dose of 1000 mg/kg bw, decreased body weight, increased serum ALAT and decreased serum albumin were observed as systemic changes, whereas macroscopic and microscopic stomach changes were observed as local changes, however the latter without relevance to humans. NOAEL for paternal/maternal toxicity was 300 mg/kg bw/day.
- For risk assessment, the NOAEL of 300 mg/kg bw with registered substance tested in the OECD 422 study was selected as dose descriptor for calculation of long term systemic DNELS. Further justification of assessment factors is explained in the DNEL justification document attached to the endpoint summary.
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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