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EC number: 939-638-8 | CAS number: 90268-37-4
- 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
Acute oral toxicity with read across substance CAS No. 90268-36-3 (Butanedioic acid, sulfo-, 1-C12-18-
alkyl esters, disodium salts) containing >= 90% active ingredient showed an LD50 between 580 and
1400 mg/kg for male and female rats in the key study; the registered substance was therefore considered
harmful if swallowed. Acute dermal toxicity testing in rats with 2 read across substances did not reveal
relevant changes and resulted in an LD50 > 2000 mg/kg bw. 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 and the risk management measures that are already implemented.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1986-1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid testing guidance, however limited data on test substance identification were provided. Nevertheless, the study is reliable, relevant and adequate for classification.
- Justification for type of information:
- See attached read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 580 - < 1 400 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 580 - < 1 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose 2000 mg/kg: 2/2 male and 2/2 female animals died 24 hours after application.
Dose 1400 mg/kg: 4/5 male animals died 24 hours after application and 5/5 female animals died 6-24 hours after application.
Dose 580 mg/kg: 0/5 male animals died 14 days after application and 1/5 female died 24hours-14 days after application. - Clinical signs:
- other: Dose 2000 mg/kg: Piloerection and decreased activity was seen in all male and female animals (4/4) after ca. 1 h. Piloerection, decreased activity and diarrhea was seen in 2/2 males after ca. 2 h and in 2/2 females after ca. 2-5 h. Piloerection, decreased
- Gross pathology:
- Dose 2000 mg/kg:
2/2 male animals had a gastro-intestinal tract high-grade filled with liquid, mucosa partially reddish discolored and low-grade emphysema. 2/2 female animals had a bloodily nose and muzzle, otherwise the same symptoms as the males.
Dose 1400 mg/kg:
4/5 males showed strongly reddish discolored medulla, emphysema of the lungs, accumulation of liquid in the thick and small intestine, 1/5 showed no pathological signs. 5/5 female animals showed showed strongly reddish discolored medulla, emphysema of the lungs, accumulation of liquid in the thick and small intestine, and in addition 1/5 female showed low-grade bleedings in the fundus area.
Dose 580 mg/kg:
The male animals had no special findings. 3/5 females had no special findings. 1/5 female had moderate hydrometra, 1/5 female showed a strongly reddish discolored medulla, emphysema of the lungs and accumulation of liquid in the thick and small intestine. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 of the read-across test item containing ≥ 90% active ingredient was <1400 mg/kg >580 mg/kg for male rats and <1400 mg/kg >580 mg/kg for female rats.
- Executive summary:
The acute oral toxicity of the read-across test item containing ≥90% act. ingr. was tested by oral gavage in young Wistar rats at dose levels of 580, 1400 and 2000 mg/kg bw. The read-across test compound was administered by single gavage in aqua dest. as solvent and an application volume of 20 mL/kg bw to fasted animals. Two (low and mid dose) or five rats (high dose) were used per sex and dose. Clinical observations and gross macroscopic observations were observed at all dose levels . The LD50was <1400 mg/kg and >580 mg/kg for male rats and <1400 mg/kg and >580 mg/kg for female rats. According to “Off. J. Europ. Commun., L 257, 1983, p. 18”, the test item can be classified as acute harmful.
Reference
Table 1. Mean body weights and body weight gain
|
Males: mean body weights (g) |
Females: mean body weights (g) |
||||
Dose (mg/kg) |
2000 |
1400 |
580 |
2000 |
1400 |
580 |
-1d |
212 |
207 |
209 |
178 |
179 |
181 |
Start experiment |
201 |
196 |
197 |
165 |
169 |
171 |
2 d |
- |
186* |
212 |
- |
- |
175 |
7 d |
- |
217* |
237 |
- |
- |
178 |
14 d |
- |
250* |
267 |
- |
- |
186 |
|
|
|
|
|
|
|
Body weight gain |
- |
43 |
58 |
- |
- |
5 |
d = days after application
* = value of one survivor
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 580 mg/kg bw
- Quality of whole database:
- High quality (Klimish 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/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- None of the animals died prematurely.
- Clinical signs:
- other: A very slight erythema (barely perceptible) on the application site was observed in all 5 of 5 male and 5 of 5 female animals on test days 2 and 3.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The read-across test item (>95% purity) requires no labelling (as LD50 > 2000 mg/kg bw).
Also, according to the EC Regulation 1272/2008 and subsequent regulations, the read-across test material is not classified for acute dermal toxicity. - Executive summary:
In this experiment, the read-across test item (>95% purity) was examined for acute toxicity after a single dermal application to rats at one dose level of 2000 mg act. ingr./kg bw. The read-across test item was applied once for 24 hours on the shaved intact dorsal skin of rats (5 cm x 6 cm, approx. 1/10 of body surface). This treatment was followed by an observation period of 2 weeks. Under the present test conditions, a single dermal administration of 2000 mg/kg bw to rats revealed no signs of toxicity and no deaths. A very slight erythema (barely perceptible) on the application site was observed in all 5 of 5 male and 5 of 5 female animals on test days 2 and 3. All animals gained the expected body weight throughout the whole experimental period. No macroscopic findings were observed at necropsy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality (Klimisch 1)
Additional information
Acute oral toxicity
No data were available for the registered substance, but read across data were available from subgroup
members (see separate read across justification document for the mono-ester sulfosuccinates in
Section 13):
- A key study for acute oral toxicity was available with test item CAS No. 90268-36-3 ( Butanedioic acid,
sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >= 90% active ingredient dosed by gavage in
Wistar rats at 480, 1400 and 2000 mg/kg bw (Potokar, 1987). Five (for low and mid dose) and two rats
(for high dose) were used per sex. Clinical observations and gross macroscopic observations were
observed at all dose levels. The LD50 was between 580 and 1400 mg/kg for male and female rats,
and therefore the test item was considered harmfull.
- A supporting study with read across substance CAS No. 37294-49-8 ( Disodium C-isodecyl
sulphonatosuccinate) in 5 male albino Wistar rats dosed with 50% active ingredient (Chemical Hygiene
Fellowship Carnegie-Mellon Institute of Research, 1975a) at 10.0; 5.0 and 2.5 mL/kg bw (5000; 2500 and
1250 mg act.ingr./kg bw). All 5 animals died within 6-24 hours after dosing at the highest dose group.
In the 5.0 mL (2500 mg act.ingr.)/kg bw dose group 3 of 5 animals died within 6-24 hours after dosing.
The 2 survivors recovered after 3 days. In the 2.5 mL (1250 mg act.ingr.)/kg bw dose group all animals
survived and recovered after 2 days. At 30 minutes they were sluggish at all dose levels. Gross autopsy
showed slight changes in the lungs, livers, spleens, stomach, intestines and kidneys. The LD50 was
4.67 mL (2340 mg act.ingr.)/kg bw.
- In conclusion, the test item is considered of low toxic potential based on the most detrimental study,
indicating an LD50 between 580 and 1400 mg/kg bw. For the LD50 value, 580 mg/kg was used as
worst case value.
Acute dermal toxicity
No data were available for the registered substance, but read across data were available from category
members (see separate read across justification document for the mono-ester sulfosuccinates in
Section 13):
- A key study for acute oral toxicity was available with test item CAS No. 90268-36-3 ( Butanedioic acid,
sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >95% active ingredient (Haferkorn, 2013).
One dose level of 2000 mg/kg bw was employed. The test item was applied once for 24 hours on the
shaved intact dorsal skin of rats (5 cm x 6 cm, approx. 1/10 of body surface). This treatment was followed
by an observation period of 2 weeks. There were no signs of toxicity and no deaths. A very slight erythema
(barely perceptible) on the application site was observed in all 5 of 5 male and 5 of 5 female animals on
test days 2 and 3. All animals gained the expected body weight throughout the whole experimental period.
No macroscopic findings were observed at necropsy.
- In a supporting study with test item CAS No. 37294-49-8 ( Disodium C-isodecyl sulphonatosuccinate)
containing 37% active ingredient (Carpenter, 1971a) at 10.0 and 5.0 mL/kg bw (3700 and 1850 mg
act.ingr./kg bw), all 5 animals of the high dose group died within 6-24 hours after dosing, whereas the
5.0 mL/kg bw dose group all animals survived and recovered after 3 days. At 15 minutes animals were
sluggish at both doses, at 1 hour there was diarrhea at 10 mL/kg. Gross autopsy showed changes in
the lungs, livers, stomach, intestines, kidneys and adrenals. The LD50 was 7.07 mL (2620 mg act.ingr.)/
kg bw.
- In conclusion, there is no hazard for acute dermal toxicity, based on read across substances showing
LD50 values >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 study is waived.
Conclusion
-
The substance is considered of low toxic potential based on the most
detrimental study, indicating an
LD50
between 580 and 1400 mg/kg bw. For the LD50 value, 580 mg/kg was used as
worst case value.
- There is no hazard for acute dermal toxicity, based on read across substances showing LD50 values >2000 mg/kg bw.
- Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely.
Justification for classification or non-classification
Base upon read across data, the test
substance is classified according to CLP regulation (No.
1272/2008 of 16 December 2008),
Category 4 for acute oral toxicity with signal word 'WARNING'.
Based on the read across data and according
CLP (No. 1272/2008 of 16 December 2008), the
test substance does not have to be
classified and has no obligatory labelling requirement for dermal
toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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