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EC number: 939-404-5 | CAS number: 1469983-43-4
- 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
Several studies for oral and dermal acute toxicity were performed on related substances, demonstrating LD50 >2000 mg/kg bw for both routes. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely due to the physchem properties of the substance and the handling during production and use
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, therefore the study is considered relevant, adequate and reliable for classification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CD/Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: At start of administration: approx. 8 weeks
- Weight at study initiation: At start of administration: 169 - 184 g
- Fasting period before study: Approx. 16 hours before administration (only tap water was then available ad libitum)
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages ( type III plus) . Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany)
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (e.g. ad libitum): Drinking water in bottles was offered ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C (maximum range)
- Humidity (%): 55% ± 15% (maximum range)
- Air changes (per hr): 12 to 18-fold air change per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 18, 2012 To: August 7, 2012 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 4.22 mL/kg bw
DOSAGE PREPARATION (if unusual):
Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts was used as supplied. The administration volume was 4.22 mL/kg bw for a dose of 2000 mg/kg bw as the density of the test item was 1.14 g/mL and a correction factor of 2.41 was employed in order to correct for a content of the solid material of 41.5% only.
The pH value of the supplied test item was 6.4.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose used is selected from a series of defined dose levels. Due to the small number of animals used with this method, there is no need to perform a range finding test. - Doses:
- 1 dose group (Limit test): 2000 mg/kg bw (dose level refers to the solids ingredients of the test item)
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern; tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma), body weight, gross pathology - Statistics:
- No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: actual ingested (gavage)
- Mortality:
- No death was recorded within the test period.
- Clinical signs:
- other: Under the present test conditions, a single oral administration of 2000 mg Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)¬alkyl))¬amino]ethyl]esters, disodium salts/kg bw did not reveal any signs of toxicity.
- Gross pathology:
- No pathological changes were observed at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions,Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts requires no classification (as LD50 > 2000 mg/kg).
Also, according to the EC Regulation 1272/2008 and subsequent regulations, the test material is not classified for acute oral toxicity. - Executive summary:
In this experiment Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts was examined for acute toxicity after a single oral administration to 6 femaleCD/Crl:CD(SD)rats. The test substance dosed by oral gavage at 2000 mg active ingredient/kg bw did not reveal any signs of toxicity. No death was recorded within the 14 days observation period. All animals gained the expected weight throughout the whole study period. No pathological changes were observed at necropsy.The LD50value was ranked exceeding 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliability 2 for all studies
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, therefore the study is considered relevant, adequate and reliable for classification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CD/Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: At dosing: Males: approx. 8 weeks; Females: Approx. 9 weeks
- Weight at study initiation: At dosing: Males: 215 - 237 g; Females: 217 – 239 g
- Fasting period before study: Approx. 16 hours before administration (only tap water was then available ad libitum)
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages ( type III plus) . Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany)
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (e.g. ad libitum): Drinking water in bottles was offered ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C (maximum range)
- Humidity (%): 55% ± 15% (maximum range)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 18, 2012 To: August 6, 2012 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The shaved intact dorsal skin, between the fore and hind extremities
- % coverage: 5 cm x 6 cm, approx. 1/10 of body surface
- Type of wrap if used: The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips (Omniplast (P. HARTMANN AG, 89522 Heidenheim, Germany) on the application site for 24 hours
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
TEST MATERIAL
- Amount(s) applied (volume or weight with unit) 4.22 mL/kg bw
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 1 dose group (Limit test): 2000 mg/kg bw (dose level refers to the solids ingredients of the test item)
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern; tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma), body weight, gross pathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- None of the animals died prematurely.
- Clinical signs:
- other: Under the present test conditions, a single dermal administration of 2000 mg Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts/kg bw to rats revealed no signs of toxicity.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions,Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts requires no labeling (as LD50 > 2000 mg/kg).
Also, according to the EC Regulation 1272/2008 and subsequent regulations, the test material is not classified for acute dermal toxicity. - Executive summary:
In this experiment, Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts was examined for acute toxicity after a single dermal application to rats. One dose level of 2000 mg/kg bw was administered on the shaved intact dorsal skin, between the fore and hind extremities of 5 male and 5 female CD/Crl:CD(SD) rats. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site for 24 hours. All animals were observed for a period of 14 days. Under the present test conditions, a single dermal administration of 2000 mg active ingredient/kg bw to rats revealed no signs of toxicity and no deaths. All animals gained the expected body weight throughout the whole experimental period. No macroscopic findings were observed at necropsy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliability 2 for all studies
Additional information
No test data were available for current substance, however read across data were available from:
a) Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18 (even numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts
b) Reaction product of (R)-12-hydroxy-N-(2-hydroxyethyl)oleamide and maleic anhydride and sodium hydrogensulfite.
c) Lanoline alcohol sulphosuccinated sodium salt.
d) Alkenes hydroformylated, sulfosuccinates, sodium salt
All results are consistent and the results can be applied also to the registered substance
Justification for selection of acute toxicity – oral endpoint
All studies are perfomed on similar substances, all composed by the same sulphosuccinic part and differrent chainlenghts: chainlenght can vary from very high molecular weight (like in hydroformilation products and lanoline) to relatively low like in the dioctyl drivative. They contribute and agree to the same result. The substance is not toxic for acute oral exposure
Justification for selection of acute toxicity – dermal endpoint
All studies are perfomed on similar substances, all composed by the same sulphosuccinic part and differrent chainlenghts: chainlenght can vary from very high molecular weight (like in hydroformilation products and lanoline) to relatively low like in the dioctyl drivative. They contribute and agree to the same result. The substance is not toxic for acute dermal exposure
Justification for classification or non-classification
Oral acute toxicity
The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:
Oral (mg/kg bodyweight)
Category 1: ATE ≤ 5
Category 2: 5 < ATE≤ 50
Category 3: 50 < ATE≤ 300
Category 4: 300 < ATE≤ 2 000
Different Sufosuccinates were tested, showing acute oral toxicity values >= 2.000 mg/Kg (range 2.000 - 3540 mg/Kg)
Inhalation acute toxicity
According to the Annex VIII of the REACH Regulation n. 1907/2006, inhalation route is not considered appropriate, based also on vapour pressure and the test can be waived.
Dermal acute toxicity
The substance is not classified for dermal toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:
Dermal (mg/kg bodyweight)
Category 1: ATE ≤ 50
Category 2: 50 < ATE≤ 200
Category 3: 200 < ATE≤ 1000
Category 4: 1000 < ATE≤ 2000
The value selected is > 2.000 mg/Kg.
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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