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Diss Factsheets
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EC number: 287-024-7 | CAS number: 85408-62-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982/09/06 to 1982/09/20
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Full study report not available just a 1 page summary. Non GLP/guideline. No substance analytical information. Test item called DEFI which is Sodium Lauroyl Isethionate.
Data source
Reference
- Reference Type:
- other: Summary report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Limited information in report which states study was an acute oral toxicity study which resulted in the derivation of an LD50
- GLP compliance:
- not specified
- Test type:
- other: LD50
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Test itemnamed in report as Directly Esterified Fatty Isethionate (DEFI).
No further details on test item identity provided.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No information
- Age at study initiation: no information
- Weight at study initiation: 170-201 g
- Fasting period before study: no information
- Housing: no information
- Diet (e.g. ad libitum): no information
- Water (e.g. ad libitum): no infomation
- Acclimation period: no information
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no information
- Humidity (%): no information
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): no information
IN-LIFE DATES: From: Unknown
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: no data
DOSAGE PREPARATION (if unusual): no data
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 3.3, 4.1, 5.1, 6.4 and 8.0 grams/kg
- No. of animals per sex per dose:
- 5 males per dose (no females)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 1,2,3,4, 7 and 14 following dosing
- Necropsy of survivors performed: no data but gross pathology stated to show no significant findings
- Other examinations performed:
Clinical signs=
Dose of 8.0 g/kg: Lethargy and moderate diarrhea observed in all animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
Dose of 6.4 g/kg: Moderate diarrhea observed in four animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
Dose of 5.1 g/kg: Moderate diarrhea observed in two animals approximately 1 hour after dosing.
Dose of 4.1 g/kg: Slight diarrhea observed in two animals approximately 2 hours after dosing.
Mean Body weights recorded at days 0, 7 and 14
Dose of 8.0g/kg: Day 0= 171g, day 7= 233g, day 14= 275g
Dose of 6.4g/kg: Day 0= 185g, day 7= 242g, day 14= 275g
Dose of 5.1g/kg: Day 0= 181g, day 7= 249g, day 14= 288g
Dose of 4.1g/kg: Day 0= 192g, day 7= 258g, day 14= 279g
Dose of 3.3g/kg: Day 0= 193g, day 7= 261g, day 14= 288g
Gross Pathology at Necropsy: No significant findings
8.0 g/kg: Day 1 - 2/2 moderate inflammation of the gastric mucosa.
Day 2 - 1/1 moderate inflammation of the gastric mucosa. - Statistics:
- No data.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 8.4 other: g/kg bw
- Remarks on result:
- other: No confidence limits calculated
- Mortality:
- Dose of 8.0g/kg: 3/5 (2 died on day 1, 1 died on day 2)
Dose of 6.4g/kg: 1/5 (1 died on day 4)
Dose of 5.1g/kg: 0/5
Dose of 4.1g/kg: 0/5
Dose of 3.3g/kg: 0/5 - Clinical signs:
- 8.0 g/kg: Lethargy and moderate diarrhea observed in all animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
6.4 g/kg: Moderate diarrhea observed in four animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
5.1 g/kg: Moderate diarrhea observed in two animals approximately 1 hour after dosing.
4.1 g/kg: Slight diarrhea observed in two animals approximately 2 hours after dosing. - Body weight:
- Dose of 8.0g/kg: Day 0= 171g, day 7= 233g, day 14= 275g
Dose of 6.4g/kg: Day 0= 185g, day 7= 242g, day 14= 275g
Dose of 5.1g/kg: Day 0= 181g, day 7= 249g, day 14= 288g
Dose of 4.1g/kg: Day 0= 192g, day 7= 258g, day 14= 279g
Dose of 3.3g/kg: Day 0= 193g, day 7= 261g, day 14= 288g - Gross pathology:
- No significant findings
8.0 g/kg: Day 1 - 2/2 moderate inflammation of the gastric mucosa.
Day 2 - 1/1 moderate inflammation of the gastric mucosa. - Other findings:
- No data
Any other information on results incl. tables
See results above.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- In an acute oral toxicity study in the male rat, the LD50 was identified as 8.4g/kg bw and as such determined to be non toxic.
- Executive summary:
In an acute oral toxicity study in the male rat, the LD50 was identified as 8.4g/kg bw and as such determined to be non toxic.
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