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EC number: 219-147-9 | CAS number: 2373-38-8
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1957
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 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:
- 1 957
- Report date:
- 1957
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
- EC Number:
- 219-147-9
- EC Name:
- Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
- Cas Number:
- 2373-38-8
- Molecular formula:
- C16H30O7S.Na
- IUPAC Name:
- sodium 1,4-bis[(4-methylpentan-2-yl)oxy]-1,4-dioxobutane-2-sulfonate
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Aerosol MA-80%, sodium dihexylsulfosuccinate
- Physical state: Clear, viscous liquid (80% solution)
- Analytical purity: 78-80%
- 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.: BV-1193A NH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Good stability in aqueous solution
- Storage condition of test material: Not provided
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Not provided
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the cuff and any excess of the dose were removed
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 mL/kg; 5 mL/kg; 10 mL/kg
- Concentration (if solution): solution containing 80 % solids ( 80 % active ingredient)
- Constant concentration used: yes; different volumes
VEHICLE
Not applicable - Duration of exposure:
- 24 hours
- Doses:
- 2.5 mL/kg, 5.0 mL/kg and 10.0 mL/kg
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- TEST SITE
- Area of exposure: trunk
- % coverage: Not provided
- Type of wrap if used: a cuff of polyethylene film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the cuff and any excess of the dose were removed
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 mL/kg, 5.0 mL/kg and 10.0 mL/kg
- Concentration (if solution): 80%
- Constant concentration used: different volumes - Statistics:
- the method of moving averages
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2.6 - < 9.6
- Remarks on result:
- other: test material is 80% solution
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 000 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- > 2 100 - < 7 700
- Mortality:
- At a dosage of 10 mL/kg there was severe erythema, edema and necrosis of the skin, and all animals died within one to three days following the removal of the dose . At the two lower dosages, there was one death each.
- Clinical signs:
- other: At a dosage of 10 mL/kg there was severe erythema, edema and necrosis of the skin, and all animals died within one to three days following the removal of the dose having exhibited extreme depression over this interval. Erythema and edema were initially q
- Gross pathology:
- Post-mortem examination in the high dose group gave additional evidence of severe injury to the skin and abdominal wall.
Survivors were observed for a total of 7 days after application of the dose, and then sacrificed. At autopsy there was no gross pathology that could be related to administration of the product.
Any other information on results incl. tables
Table 1. Dosage & Results
Animal Number |
Body weight in Grams |
Weight Change in 7 Days |
Dosage in mL/kg |
Dose in mL |
Days to Death |
H 815 |
3372 |
- |
10.0 |
33.7 |
3 |
H 817 |
3562 |
- |
10.0 |
35.6 |
2 |
H 818 |
3900 |
- |
10.0 |
39.0 |
2 |
H 819 |
3580 |
- |
10.0 |
35.8 |
<1 |
H 821 |
2720 |
- |
10.0 |
27.2 |
<1 |
|
|
|
|
|
|
H 823 |
3680 |
-160 |
5.0 |
18.4 |
S |
H 824 |
3142 |
- |
5.0 |
15.7 |
4 |
H 825 |
4098 |
-987 |
5.0 |
20.5 |
S |
H 826 |
3091 |
-182 |
5.0 |
15.5 |
S |
|
|
|
|
|
|
H 832 |
3729 |
-161 |
2.5 |
9.3 |
S |
H 833 |
3557 |
-237 |
2.5 |
8.9 |
S |
H 835 |
3805 |
- |
2.5 |
9.5 |
4 |
H 836 |
4120 |
-408 |
2.5 |
10.3 |
S |
S= Survived
LD50 =5.0 (2.6-9.6) mL/kg as 80% solution
LD50 =4.0 (2.1-7.7) g/kg as contained solids
NOTE: For purposes of calculation of anLD50 by the method of moving averages, a mortality of 4/4 at
20 mL/kg is assumed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item for male albino rabbits by single skin application under these circumstances is 5.0 (2.6-9.6) mL/kg, corresponding with 4.0 g/kg bw of the active ingredient.
For purposes of calculation of an LD50 by the method of moving averages a mortality of 4/4 at 20 mL/kg is assumed. - Executive summary:
The test item as received (solution containing 80% solids) was supplied to the closely-clipped skin of male albino rabbits in single doses that remained in contact with the skin for a period of 24 hours. Four animals were used at each of three dosage levels; namely, 2.5 mL/kg, 5 mL/kg and 10 mL/kg respectively. The dose was retained by means of a cuff of polyethylene film which encircled the trunk of the animal. At the end of the period of exposure, the cuff and any excess of the dose were removed, and the skin examined for primary irritation.
At a dosage of 10 mL/kg there was severe erythema, edema and necrosis of the skin, and all animals died within one to three days following the removal of the dose having exhibited extreme depression over this interval. Post-mortem examination gave additional evidence of severe injury to the skin and abdominal wall. At the two lower dosages, there was one death each, and the LD50 was calculated to be 5.0 (2.6-9.6) mL/kg, or 4.0 g/kg bw of the active ingredient.
Erythema and edema were initially quite severe at the lower dosages, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. Survivors were observed for a total of 7 days after application of the dose, and then sacrificed. At autopsy there was no gross pathology that could be related to administration of the product.
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