Registration Dossier
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EC number: 939-638-8 | 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

Endpoint summary
Administrative data
Description of key information
Acute oral toxicity with read across substance CAS No. 90268-36-3 (Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >= 90% active ingredient showed an LD50 between 580 and 1400 mg/kg for male and female rats in the key study; the registered substance was therefore considered harmful if swallowed. Acute dermal toxicity testing in rats with 2 read across substances did not reveal relevant changes and resulted in an LD50 > 2000 mg/kg bw. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties and the risk management measures that are already implemented.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 580 mg/kg bw
- Quality of whole database:
- High quality (Klimish 2)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality (Klimisch 1)
Additional information
Acute oral toxicity
No data were available for the registered substance, but read across data were available from subgroup members (see separate read across justification document for the mono-ester sulfosuccinates in Section 13):
- A key study for acute oral toxicity was available with test item CAS No. 90268-36-3 ( Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >= 90% active ingredient dosed by gavage in Wistar rats at 480, 1400 and 2000 mg/kg bw (Potokar, 1987). Five (for low and mid dose) and two rats (for high dose) were used per sex. Clinical observations and gross macroscopic observations were observed at all dose levels. The LD50was between 580 and 1400 mg/kg for male and female rats, and therefore the test item was considered harmfull.
- A supporting study with read across substance CAS No. 37294-49-8 ( Disodium C-isodecyl sulphonatosuccinate) in 5 male albino Wistar rats dosed with 50% active ingredient (Chemical Hygiene Fellowship Carnegie-Mellon Institute of Research, 1975a) at 10.0; 5.0 and 2.5 mL/kg bw (5000; 2500 and 1250 mg act.ingr./kg bw). All 5 animals died within 6-24 hours after dosing at the highest dose group. In the 5.0 mL (2500 mg act.ingr.)/kg bw dose group 3 of 5 animals died within 6-24 hours after dosing. The 2 survivors recovered after 3 days. In the 2.5 mL (1250 mg act.ingr.)/kg bw dose group all animals survived and recovered after 2 days. At 30 minutes they were sluggish at all dose levels. Gross autopsy showed slight changes in the lungs, livers, spleens, stomach, intestines and kidneys. The LD50was 4.67 mL (2340 mg act.ingr.)/kg bw.
- In conclusion, the test item is considered of low toxic potential based on the most detrimental study, indicating an LD50 between 580 and 1400 mg/kg bw. For the LD50value, 580 mg/kg was used as worst case value.
Acute dermal toxicity
No data were available for the registered substance, but read across data were available from category members (see separate read across justification document for the mono-ester sulfosuccinates in Section 13):
- A key study for acute oral toxicity was available with test item CAS No. 90268-36-3 ( Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >95% active ingredient (Haferkorn, 2013). One dose level of 2000 mg/kg bw was employed. The test item was applied once for 24 hours on the shaved intact dorsal skin of rats (5 cm x 6 cm, approx. 1/10 of body surface). This treatment was followed by an observation period of 2 weeks. There were no signs of toxicity and no deaths. A very slight erythema (barely perceptible) on the application site was observed in all 5 of 5 male and 5 of 5 female animals on test days 2 and 3. All animals gained the expected body weight throughout the whole experimental period. No macroscopic findings were observed at necropsy.
- In a supporting study with test item CAS No. 37294-49-8 ( Disodium C-isodecyl sulphonatosuccinate) containing 37% active ingredient (Carpenter, 1971a) at 10.0 and 5.0 mL/kg bw (3700 and 1850 mg act.ingr./kg bw), all 5 animals of the high dose group died within 6-24 hours after dosing, whereas the 5.0 mL/kg bw dose group all animals survived and recovered after 3 days. At 15 minutes animals were sluggish at both doses, at 1 hour there was diarrhea at 10 mL/kg. Gross autopsy showed changes in the lungs, livers, stomach, intestines, kidneys and adrenals. The LD50was 7.07 mL (2620 mg act.ingr.)/kg bw.
- In conclusion, there is no hazard for acute dermal toxicity, based on read across substances showing LD50values >2000 mg/kg bw.
Acute inhalation toxicity
Inhalation is very unlikely due to large particle size, low vapour pressure and high hydrophilic properties of the substance. Based on these and other physicochemical properties, the inhalation route is not appropriate; the oral and dermal route of administration are therefore applied as first and second relevant routes (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications. On the basis of the argumentation summarized above an acute inhalation toxicity study is waived.
Conclusion
- The substance is considered of low toxic potential based on the most detrimental study, indicating an LD50 between 580 and 1400 mg/kg bw. For the LD50value, 580 mg/kg was used as worst case value.
- There is no hazard for acute dermal toxicity, based on read across substances showing LD50values >2000 mg/kg bw.
- Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely.
Justification for selection of acute toxicity – oral endpoint
Key study
Justification for selection of acute toxicity – dermal endpoint
Key study
Justification for classification or non-classification
Base upon read across data, the test substance is classified as HARMFUL and the symbol 'Xn' and risk phrase R 22 'HARMFUL IF SWALLOWED' are required according the EU labelling regulations Commision directive 93/21/EEC. According to CLP regulation (No. 1272/2008 of 16 December 2008), Category 4 classification is proposed for acute oral toxicity with signal word 'WARNING'.
Based on the read across data and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), the test substance does not have to be classified and has no obligatory labelling requirement for dermal toxicity.
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