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EC number: 303-773-5 | CAS number: 94213-67-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No. of animals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 79/831/EWG, Annex V, Part B
- Principles of method if other than guideline:
- 2-5 animals/sex/dose; Orientation test.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 90268-36-3
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sulfosuccinat 128 P
- Physical state: White powder
- Analytical purity:>=90%
- 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/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: young
- Weight at study initiation: fasted mean weight 165-201 g
- Fasting period before study: ca. 16 hours before and 3 hours after application
- Housing: 2-5 animals per Makrolon 3 cage, soft wood granulates(ARWI-Center, Essen) as bedding
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324 (Fa. Altromin GmbH, 4937 Lage) ad libitum
- Water (e.g. ad libitum): Public supply, ad libitum
- Acclimation period: 7 or 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20-25°C
- Humidity (%): ca. 45-60%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 25.111986-03.02.1987
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10%, 7.0% and 2.9% (w/v)
MAXIMUM DOSE VOLUME APPLIED: 20 mL/ kg - Doses:
- 2000 mg/kg ; 1400 mg/kg; 580 mg/kg
- No. of animals per sex per dose:
- 2 high dose
5 mid dose and low dose - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms and mortality several times at the day of application, thereafter twice daily. Body weight 1 day before application;before application (fasted) on the day of application; 48 hours, 7 and 14 days after application.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 580 - < 1 400 mg/kg bw
- Based on:
- test mat.
- Key result
- 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 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.
Any other information on results incl. tables
Males: mean body weights (g) Females: mean body weights (g)
Dose (mg/kg 2000 1400 580 2000 1400 580
-1 day 212 207 209 178 179 181
Start experiment 201 196 197 165 169 171
+ 2 days - 186* 212 - - 175
+ 7 days - 217* 237 - - 178
+ 14 days - 250* 267 - - 186
Body weight gain - 43 58 - - 5
*= value of one survivor
Applicant's summary and conclusion
- Interpretation of results:
- other: acute harmful
- Remarks:
- Criteria used for interpretation of results: other: : Off. J. Europ. Comm., L 257, 1983, p.18
- Conclusions:
- The oral LD50 of the 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 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 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.
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