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EC number: 249-894-6 | CAS number: 29857-13-4
- 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
Except for an acute oral toxicity study, no test data were available for current substance, however read across data were available from read-across substances CAS No. 23386-52-9 and CAS No. 55184-72-0. LD50 values were > 2000 mg act.ingr./kg bw. for oral and dermal acute toxicity in key and supporting studies. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods. Although some details were missing, the the study is considered relevant, adequate and reliable for classification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar Hoe:WISKf (SPF71)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, SPF
- Age at study initiation: Males ca. 7 weeks; Females ca. 8 weeks
- Weight at study initiation: 158 g mean weight males; 154 g mean weight females
- Fasting period before study: Ca. 16 hours before and 3-4 hours after application
- Housing: In groups of 5 animals, in Makrolon cages (Type 4) on softwood pellets
- Diet (e.g. ad libitum): Rattendiät Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: deionised water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations after 10, 30 minutes, 1, 2, 4, 6 hours and then daily; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 260 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality observed.
- Clinical signs:
- other: On the day of application the animals showed nonspecific signs of toxicity. The female animals showed in addition adverse effects of the movement sequence, respiration and diarrhea. From the second day post application all the symptoms were reversible.
- Gross pathology:
- No gross pathology was observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item in male and female Wistar rats is > 2000 mg/kg bw. The test item does not require labeling according to the classification criteria of Directive 83/467/EEC and the Hazardous Substances Regulation.
- Executive summary:
Acute oral toxicity of a formulation containing 36 -67% active ingredient was tested in 10 Wistar rats (5 males and 5 females) by oral gavage of the test item in deionised water at a dose of 2000 mg/kg bw. No mortality was observed. On the day of application the animals showed nonspecific signs of toxicity. The female animals showed in addition adverse effects of the movement sequence, respiration and diarrhea. From the second day post application all the symptoms were reversible. There were no adverse effects on the bodyweight gain. No gross pathology of the euthanized animals was observed. The LD50 in male and female Wistar rats is > 2000 mg/kg bw (test material) or > 1260 mg/kg bw (active ingredient).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 2
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See attached read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 1/10 animals died on the sixth day after dosing.
- Clinical signs:
- other: Hind leg weakness
- Gross pathology:
- Gross pathology of the survivors was normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This read-across test item is considered to be pratically non-toxic by single skin application.
- Executive summary:
Acute dermal toxicity was tested in 10 male albino rabbits under covered application to the clipped skin of 5.0 g read-across substance Sodium dicyclohexyl sulfosuccinate (80% active ). There was one mortality at day 6 and weakness of the hind legs was seen in one animal. The survivors showed no gross autopsy.There was a severe erythema and severe edema followed by eschar formation. Dermal LD50 was >5000 mg/kg bw. Taking into account that the read-across test item contained 80% active ingredient, the LD50 corresponds with >4000 mg active ingredient/kg bw.
This read-across test item is considered to be practically non-toxic by single skin application.
Reference
Table 1. Single dermal dose in male albino rabbits
An aqueous paste of the product was held under an impervious cuff in continuous 24-hour
contact with the shaved skin.
Dosage |
Onset of (S) Signs, (D) Death, Hours and Days |
DIED |
Mean Wt. |
Time of (R) Recovery, Days |
|||||||||||||||
DOSED |
|||||||||||||||||||
0-6 |
6-24 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
|
I |
T |
1 |
2 |
3 |
4 |
5 |
6 |
7-14 |
|
5.0 g/kg |
|
|
|
S |
|
|
D1 |
|
|
1/10 |
2.84 |
2.75 |
|
|
|
|
|
|
R |
LD50 greater than 5.0 g/kg
Signs of intoxication: Hind leg weakness.
Skin irritation: Severe erythema and severe edema followed by eschar formation.
Gross autopsy: Survivors-normal
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 500 mg/kg bw
Additional information
Except for an acute oral toxicity study, no test data were available for current substance, however read across data were available from CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate) and CAS number 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt). Justification for read across within the category of sulfosuccinates Diesters is documented in a separate document attached in Section 13.
Acute oral toxicity
- A key acute oral toxicity study with a formulation of the registered substance containing 63 - 67% active ingredient was tested in 10 Wistar rats (5 males and 5 females) by oral gavage at a dose of 2000 mg/kg bw test material (Hofman and Jung, 1988). No mortality was observed. On the day of application the animals showed nonspecific signs of toxicity. The female animals showed in addition adverse effects of the movement sequence, respiration and diarrhea. From the second day post application all the symptoms were reversible. There were no adverse effects on the bodyweight gain. No gross pathology of the euthanized animals was observed.The LD50 in male and female Wistar rats is >2000 mg/kg bw (test material) or >1260 mg/kg bw (active ingredient).
- Supporting oral acute toxicity studies were available from:
a. source chemical CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate), which was tested in 5 male albino Wistar rats with a test item containing 80% active ingredient (American Cyanamid Company, 1969a). Final doses were 10.0, 5.0, 2.5 and 1.25 g act. ingr./kg bw. In the 10.0 and 5.0 g/kg bw dose group all 5 animals died within 6 hours after dosing. In the 2.5 and 1.25 g/kg bw dose group all animals survived the 14 days observation period. In all dose groups signs of intoxication were observed. The LD50 was calculated to be 3540 mg/kg on product basis or 2830 mg active ingredient/kg bw.
b. source chemical CAS No. 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt), tested in male and female Wistar rats with a test item containing 70% active ingredient at 10, 5, 2.5 and 1.25 mL/kg bw, corresponding to 7000, 3500, 1750 and 875 mg act.ingr./kg bw (American Cyanamid Company, 1968a).There were no mortalities. There were no signs of intoxication observed and gross autopsy was normal. The oral LD50 was >10 mL/kg bw or >7000 mg act.ingr./kg bw.
In conclusion, based on the registered substance and read across data from key and supporting studies, there is no acute toxicity hazard as LD50 is >2000 mg/kg bw (active ingredient).
Acute dermal toxicity
For acute dermal toxicity, following read across data were available:
- source chemical CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate - 80% purity), which was tested at 5.0 g/kg bw in 10 male albino rabbits on clipped skin under covered application. There was one mortality at day 6 and weakness of the hind legs was seen in one animal. The survivors showed no gross autopsy. There was a severe erythema and severe edema followed by eschar formation. Dermal LD50 was >5000 mg/kg bw. Taking into account that the product contained 80% active ingredient, the LD50 corresponds with >4000 mg active ingredient/kg bw (Key study; American Cyanamid Company, 1969b).
- source chemical CAS No. 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt - 70% purity), which was tested in 2 groups of 5 male albino rabbits on shaved skin under covered application for 24 hours at dosages of 5.0 mL/kg and 2.5 mL/kg, corresponding to 3500 and 1750 mg active ingredient/kg bw. There were no mortalities. There were 2 animals with diarrhea but gross autopsy was normal. The oral LD50 of the test item was > 5 mL/kg bw or > 3500 mg active ingredient/kg bw (Supporting study; American Cyanamid Company, 1968b).
Based on the above data, current test item can also be considered to be practically non-toxic by single skin applications.
In conclusion, based on the read across data, there is no acute toxicity hazard as LD50 is >2000 mg/kg bw.
Acute inhalation toxicity
Inhalation is very unlikely due to large particle size, low vapour pressure and high hydrophilic properties of the substance. Based on these and other physicochemical properties, the inhalation route is not appropriate; the oral and dermal route of administration are therefore applied as first and second relevant routes (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications.
On the basis of the argumentation summarized above an acute inhalation toxicity is waived.
Conclusion
Except for an acute oral toxicity study, no test data were available for current substance, however read across data were available from read-across substances CAS No. 23386-52-9 and CAS No. 848588-96-5. LD50 values were > 2000 mg act.ingr./kg bw. for oral and dermal acute toxicity in key and supporting studies. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties.
Justification for classification or non-classification
Based on these results and according to CLP regulation (No. 1272/2008 of 16 December 2008), the test substance does not have to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity.
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