Registration Dossier
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EC number: 259-515-6 | CAS number: 55184-72-0
- 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:
- 1 416.82 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):
- 8.4
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11 901 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Key 90-day oral toxicity study available; no repeated dose inhalation toxicity study available.
- 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:
- 1.4
- Justification:
- Extrapolation from subchronic 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 (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:
- 200.89 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):
- 33.6
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Key 90-day oral toxicity study available; no repeated dose dermal toxicity study available.
- 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:
- 1.4
- Justification:
- Extrapolation from subchronic 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 (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The following source information was taken into account for DNEL calculation:
- A 28 day study with dietary feeding of a registered substance containing 97 -98% active ingredient was available in male rats dosed at 100, 1000 and 10000 ppm in the diet (corresponding with 7.47, 74.7 and 812 mg act.ingr./kg bw/day on average). Animals dosed at 1000 and 10000 ppm levels showed a slightly greater retardation in growth than rats at 100 ppm. Food consumption for all groups was comparable to the controls during the 28-day period. One control animal died after 4 days of feeding. Gross autopsy revealed some incidence of intestinal irritation at all levels. Various other findings were observed at necropsy, however a respiratory infection was present, therefore the interpretation of the study is difficult. The study was considered to be supporting, and further 28 -day testing was waived based on the availability of 90 -day toxicity data.
- A key 90-day study was available for the registered substance in 40 albino rats (20 males, 20 females) were fed with 1% of various test items mixed into the diet. In the same study, various members of the Sulfosuccinates Diester Group were tested (Plank et al, 1969). No significant differences in clinical blood chemistry studies and absolute organ weights have been detected, except a slight increase in SGPT (serum glutamic pyruvic transaminase) and SAP (serum alkaline phosphatase). Body weights, organ to body weight ratios, hematologic studies and urinalysis were not different between test and control animals. No deaths or abnormal behavioral reactions occurred; no gross pathological findings were noted. Administration of category members at 1% in the diet (10000 ppm equivalent to ca.750 mg act. ingr./kg body weight/day on average basis) for 90 days in rats did not result in any relevant changes in the subchronic toxicity study. The NOAEL was therefore considered to be worst case 750 mg/kg bw/day.
- The fact that no relevant target organ changes were seen up to highest concentration of 1% in diet for 90 days, allows to conclude that corresponding intake of 750 mg/kg bw is NOAEL. A justification for calculation of DNELs is attached.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 419.25 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):
- 14
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Key 90-day oral toxicity study available; no repeated dose inhalation toxicity study available.
- 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:
- 1.4
- Justification:
- Extrapolation from subchronic 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 (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:
- 120.54 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: E ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 56
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Key 90-day oral toxicity study available; no repeated dose dermal toxicity study available.
- 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:
- 1.4
- Justification:
- Extrapolation from subchronic 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 (no further information necessary)
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:
- 13.39 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):
- 56
- Dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable
- 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:
- 1.4
- Justification:
- Extrapolation from subchronic 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The following source information was taken into account for DNEL calculation:
- A 28 day study with dietary feeding of a registered substance containing 97 -98% active ingredient was available in male rats dosed at 100, 1000 and 10000 ppm in the diet (corresponding with 7.47, 74.7 and 812 mg act.ingr./kg bw/day on average). Animals dosed at 1000 and 10000 ppm levels showed a slightly greater retardation in growth than rats at 100 ppm. Food consumption for all groups was comparable to the controls during the 28-day period. One control animal died after 4 days of feeding. Gross autopsy revealed some incidence of intestinal irritation at all levels. Various other findings were observed at necropsy, however a respiratory infection was present, therefore the interpretation of the study is difficult. The study was considered to be supporting, and further 28 -day testing was waived based on the availability of 90 -day toxicity data.
- A key 90-day study was available for the registered substance in 40 albino rats (20 males, 20 females) were fed with 1% of various test items mixed into the diet. In the same study, various members of the Sulfosuccinates Diester Group were tested (Plank et al, 1969). No significant differences in clinical blood chemistry studies and absolute organ weights have been detected, except a slight increase in SGPT (serum glutamic pyruvic transaminase) and SAP (serum alkaline phosphatase). Body weights, organ to body weight ratios, hematologic studies and urinalysis were not different between test and control animals. No deaths or abnormal behavioral reactions occurred; no gross pathological findings were noted. Administration of category members at 1% in the diet (10000 ppm equivalent to ca.750 mg act. ingr./kg body weight/day on average basis) for 90 days in rats did not result in any relevant changes in the subchronic toxicity study. The NOAEL was therefore considered to be worst case 750 mg/kg bw/day.
- The fact that no relevant target organ changes were seen up to highest concentration of 1% in diet for 90 days, allows to conclude that corresponding intake of 750 mg/kg bw is NOAEL. A justification for calculation of DNELs is attached.
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