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Diss Factsheets
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EC number: 247-873-6 | CAS number: 26650-05-5
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1964-10-24 to 1965-03-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable, sufficiently documented study performed before implementation of corresponding international guidelines which meets basic scientific principles. However, only two animals included in each dose group, therefore it is adequate for classification.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in foods, drugs and cosmetics of the association of food and drug officials of the United States 1959
- GLP compliance:
- no
- Remarks:
- study performance before implementation of GLP
Test material
- Reference substance name:
- Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate
- EC Number:
- 247-873-6
- EC Name:
- Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate
- Cas Number:
- 26650-05-5
- Molecular formula:
- C17H29NO8S.2Na
- IUPAC Name:
- disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate
- Details on test material:
- - Name of test material (as cited in study report): SBU 185 (50 % aqueous solution)
- Substance type: Sulfosuccinate (tensio-active)
- Physical state: Aqueous solution
- Analytical purity: Not provided
- Impurities (identity and concentrations): 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
- Other: the registered trade mark for SBU 185 in Germany is Steinazid SBU 185, in Great Britain: Loramine SBU 185
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): ad libitum, standardised laboratory diet supplemented with vitamin C
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Details on exposure:
- see Details on study design
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 20 applications (no treatment during the weekends); applicated test material was not washed off
- Frequency of treatment:
- daily, except during the weekends
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.357 other: mL/kg bw
- Remarks:
- nominal per unit body weight
- Dose / conc.:
- 0.714 other: mL/kg bw
- Remarks:
- nominal per unit body weight
- Dose / conc.:
- 1.428 other: mL/kg bw
- Remarks:
- nominal per unit body weight
- No. of animals per sex per dose:
- 2 (1 male, 1 female)
- Control animals:
- yes, sham-exposed
- Details on study design:
- A total of 8 healthy albino rabbits was used for this test. 3 dose levels 0.357 mL/kg, 0.714 mLkg and 1.428 mL/kg of SBU 185 (50 % aqueous solution; 24.5% act. ingr. minimum) were used. An area of approximately 10% of the total body surface of the animals on the back was clipped free of hair. In each dosage group one animal's skin remained intact, the other animal's skin was abraded. The test substance was applied by gentle inunction, using a glass rod. A total of 20 applications was performed. Applications were made every day except during the weekends. The controls were prepared and treated in the same way, but no SBU 185 was used. Readings of the skin reactions were done daily during the period of the 20 applications. The skin reactions were evaluated according to the following table:
Evaluation of skin reactions:
- Erythema and Eschar Formation
No erythema: score 0
Very slight erythema (barely perceptible): score 1
Well defined erythema: score 2
Moderate to severe erythema: score 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): score 4
Total possible erythema score: 4
- Edema Formation
No edema: score 0
Very slight edema (barely peroeptible): score 1
Slight edema (edges of area well defined by definite raising): score 2
Moderate edema (raised approximately 1 mm): score 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): score 4
Total possible edema score: 4
Furthermore, the animals were observed for a two-week period, following final exposures. During the test and the observation period body weights, food consumption, and behavior were checked daily. Urine was checked at the beginning and at the end of the total test for the presence of protein, reducing substances, blood pigments or any abnormality in gross appearance. Also observations for changes in blood morphology were made. Microscopic examinations were made of the tissues of 1 animal each of the group with the lowest and highest dose level. - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION: Yes
- Time schedule for examinations: daily
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at study start and at the end of the post application observation period
CLINICAL CHEMISTRY: No
URINALYSIS: Yes
- Time schedule for collection of urine: at study start and at the end of the post application observation period
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes, liver, kidneys, spleen, skin untreated and skin untreated - Other examinations:
- no
- Statistics:
- no
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- The skin reactions observed show that SBU 185 (50 % aqueous solution) causes in all dose levels after 20 applications a mild to moderate irritation with erythema scores 0.1 to 3 but no edema.
No dose related effects on body weight gain and food consumption.
The urine and blood data show no significant deviations from the norms, respectively between the initial and final readings.
Neither the macroscopical nor the microscopical histopathological examination of the tissues of 1 animal each of the group with the lowest and highest dose level revealed any serious damage. The treated skin of the animal treated with 1.428 mL SBU 185 (50 % aqueous solution)/kg bw showed slight hyperkeratosis and slight chronical inflammation in the stratum papilare.
Effect levels
open allclose all
- Dose descriptor:
- LOEL
- Remarks:
- dermal
- Effect level:
- 0 other:
- Based on:
- test mat.
- Remarks:
- 50% aqueous solution
- Dose descriptor:
- LOEL
- Remarks:
- dermal
- Effect level:
- 89 mg/kg bw/day
- Based on:
- act. ingr.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
In a repeated dermal dose toxicity study in rabbits dose levels of 0.357, 0.714 and 1.428 mL/kg SBU 185 (50 % aqueous solution) were applied in two animals per dose group on an area of approximately 10% of the total body surface (back). One animal's skin remained intact, the other animal's skin was abraded. Readings of the skin reactions were done daily during the period of the 20 applications. The skin reactions were evaluated comparable to Draize. Furthermore, the animals were observed for a two-week period, following final exposures. During the test and the observation period body weights, food consumption, and behavior were checked daily. Urine was checked at the beginning and at the end of the total test for the presence of protein, reducing substances, blood pigments or any abnormality in gross appearance. Also observations for changes in blood morphology were made. Microscopic examinations were made of the tissues of 1 animal each of the group with the lowest and highest dose level.
The skin reactions observed show that SBU 185 (50 % aqueous solution) caused a mild to moderate irritation with erythema scores 0.1 to 3 but no edema at all dose levels.
No dose related effects on body weight gain and food consumption were observed.
The urine and blood data showed no significant deviations from the norms, respectively between the initial and final readings.
Neither the macroscopical nor the microscopical histopathological examination of the tissues of 1 animal each of the group with the lowest and highest dose level revealed any serious damage. The treated skin of the animal treated with 1.428 mL SBU 185 (50 % aqueous solution)/kg bw showed slight hyperkeratosis and slight chronical inflammation in the stratum papilare.
Solid content of SBU 185 according to producers information: minimum 49 %. Taking this value into account, solid content of the 50 % test solution was 24.5 % in minimum.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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