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Diss Factsheets
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EC number: 245-629-3 | CAS number: 23386-52-9
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted non-GLP, with limited data on study design, however the study was conducted according to state of the art methods at that time period. The study is considered adequate, reliable and relevant.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium 1,4-dicyclohexyl sulphonatosuccinate
- EC Number:
- 245-629-3
- EC Name:
- Sodium 1,4-dicyclohexyl sulphonatosuccinate
- Cas Number:
- 23386-52-9
- Molecular formula:
- C16H26O7S.Na
- IUPAC Name:
- sodium 1,4-bis(cyclohexyloxy)-1,4-dioxobutane-2-sulfonate
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Surfactant E-196 (80% active)
- Physical state: Not provided, however it is assumed to be a viscous liquid
- Analytical purity: 80%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: mean weight 150-151 g
- Fasting period before study: 24 hours
- Housing: Not provided
- Diet (e.g. ad libitum): Not provided
- Water (e.g. ad libitum): Not provided
- Acclimation period: Not provided
ENVIRONMENTAL CONDITIONS
Not provided
IN-LIFE DATES: Not provided
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% w/v aqueous solution
- Justification for choice of vehicle: high solubility
MAXIMUM DOSE VOLUME APPLIED: 10.0 g/kg - Doses:
- 10.0, 5.0, 2.5 and 1.25 g test item/kg bw.
- No. of animals per sex per dose:
- 5 males per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequency of observations=daily; Initial and
Terminal weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not provided
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 540 mg/kg bw
- Based on:
- dissolved
- Remarks:
- 20% w/v aqueous dispersion of the product
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 830 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 5/5 animals in the 10.0 g/kg and 5.0 g/kg dose group died in the first 6 hours after dosing .
0/5 animals in the 2.5 g/kg and 1.25 g/kg dose group died during the 14 day observation period. - Clinical signs:
- other: Diarrhea, lethargy, prostration, comatose
- Gross pathology:
- Survivors-normal
- Other findings:
- None
Any other information on results incl. tables
Table 1: Single oral dose Surfactant E-196 (80% active) in male albino rats.
Animals fasted for 24 hours were dosed with 20% w/v aqueous dispersion of the product.
Dosage |
Onset of (S) Signs, (D) Death, Hours and Days |
DIED |
Mean Wt. |
Time of Recovery, Days |
|||||||||||||||
0-6 |
6-24 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
DOSED |
I |
T |
1 |
2 |
3 |
4 |
5 |
6 |
7-14 |
|
10.0 g/kg |
SD5 |
|
|
|
|
|
|
|
|
5/5 |
151 |
- |
|
|
|
|
|
|
|
5.0 g/kg |
SD5 |
|
|
|
|
|
|
|
|
5/5 |
150 |
- |
|
|
|
|
|
|
|
2.5 g/kg |
S |
|
|
|
|
|
|
|
|
0/5 |
151 |
255 |
R |
|
|
|
|
|
|
1.25 g/kg |
S |
|
|
|
|
|
|
|
|
0/5 |
150 |
265 |
R |
|
|
|
|
|
|
LD50= 3.54 g/kg with no range calculable (20% w/v dispersion)
Signs of intoxication: Diarrhea, lethargy, prostration, comatose.
Gross Autopsy: Survivors-normal.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of Surfactant E-196 (80% active) dosed as an 20% w/v aqueous dispersion = 3.54 g/kg with no calculable range.
The product is considered to be slightly toxic by ingestion in single doses at very high doses (above limit dose) . - Executive summary:
Oral acute toxicity was tested in 5 male albino Wistar rats with a 20% w/v aqueous dispersion of Butanedioic acid, sulfo-, 1,4 -dicyclohexyl ester, sodium salt (80% purity) at 10000, 5000, 2500 and 1250 mg test item/kg bw. In the 10000 and 5000 mg/kg bw dose group all 5 animals died within 6 hours after dosing. In the 2500 and 1250 mg/kg bw dose group all animals survived the 14 days observation period. In all dose groups signs of intoxication were observed ( diarrhea, lethargy, prostration, comatose) and gross autopsy of the survivors was normal.The LD50 was calculated to be 3540 mg/kg; taking into account that the product contained 80% active ingredient LD 50 is corresponding to 2830 mg act.ingr./kg bw.
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