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Diss Factsheets
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EC number: 827-581-0 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Remarks:
- Read-across to DEFI
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This is a one page report with limited details provided. However, the results serve to indicate the low toxicity of the test substance.
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
Cross-reference
- Reason / purpose for cross-reference:
- assessment report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Guideline:
- other: In house method G.2.2.1.
- Principles of method if other than guideline:
- 5 groups of male Sprague Dawley rats were given a single dose of DEFI (20% concentration) on day 1 doses of 3.3, 4.1, 5.1, 6.4 and 8.0 g/kg. Animals were observed for mortality and clinical signs on days 1, 2, 3, 4, 7 and 14, with bodyweight measured on days 0, 7 and 14.
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts
- EC Number:
- 287-024-7
- EC Name:
- Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts
- Cas Number:
- 85408-62-4
- IUPAC Name:
- 85408-62-4
- Reference substance name:
- Sodium 2-sulphonatoethyl laurate
- EC Number:
- 230-949-8
- EC Name:
- Sodium 2-sulphonatoethyl laurate
- Cas Number:
- 7381-01-3
- Molecular formula:
- C14H28O5S.Na
- IUPAC Name:
- sodium 2-(dodecanoyloxy)ethanesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Sodium Lauroyl Isethionate
- Molecular formula (if other than submission substance): Na.SO3-CH2-CH2-O-CO-(CH2)10-CH3
- Molecular weight (if other than submission substance): 344.419g/mol
- Smiles notation (if other than submission substance): [O-]S(=O)(CCOC(CCCCCCCCCCC)=O)=O.[Na+]
- InChl (if other than submission substance): no data
- Substance type: organic
- Physical state: aqueous solution
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): no data
- Specific activity (if radiolabelling): 36.8 X 10exp6 dpm/mL (1.7 uCi/mg)
- Locations of the label (if radiolabelling): 1st Carbon of Lauroyl chain
- Expiration date of radiochemical substance (if radiolabelling): no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 170-201g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: not reported - Doses:
- Single doses of 3.3, 4.1, 5.1, 6.4 and 8.0 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and other overt signs on days 1, 2, 3, 4, 7, and 14. Body weights were measured on days 0, 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- Probit (E1-2)
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 8 400 mg/kg bw
- Mortality:
- Mortalities were observed in the two highest dose groups only. In the 8 g/kg group, 2 animals died on day 1 and 1 on day 2. In the 6.4 g/kg group one animal died on day 4.
- Clinical signs:
- Slight diarrhea was observed in two animals in the 4.1 g/kg dose within 1-2 hours after dosing. Moderate diarrhea was observed in two, four and five animals about 1 hour after dosing in the 5.1, 6.4, and 8.0 g/kg bw doses, respectively. Lethargy was observed in all 8.0 g/kg dose animals 1 hour after dosing. Some lethargy was also observed at about 22 hours in a single animal each at the 6.4 and 8.0 doses
- Body weight:
- No significant effects to body weight were observed.
- Gross pathology:
- Gross pathology at necropsy revealed no significant findings.
Moderate inflammation of the gastric mucosa was observed in the animals that died on day 1 and 2 in the 8.0 g/kg bw dose.
Any other information on results incl. tables
Mortalities were observed in the two highest dose groups only. In the 8 g/kg group, 2 animals died on day 1 and 1 on day 2. In the 6.4 mg/kg group one animal died on day 4.
Clinical signs were observed in all dose groups except the lowest (3.1 g/kg).
Lethargy was observed in all 8 mg/kg dose group animals approximately 1 hour after dosing. Some lethargy was also observed at about 22 hours in a single animal each at the 6.4 and 8.0 g/kg doses.
Diarrhoea was observed in the 4.1, 5.1, 6.4 and 8 g/kg dose groups. Moderate diarrhoea was observed in two, four and five animals about 1 hour after dosing in the 5.1, 6.4, and 8.0 g/kg bw doses, respectively. Slight diarrhoea was observed in two animals in the 4.1 g/kg dose within 1-2 hours after dosing.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study performed similar to current guidelines DEFI is considered to be of low toxicity, with a LD50 of 8.4 g/kg.
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