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Diss Factsheets
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EC number: 424-970-3 | CAS number: -
- 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
Reliable acute toxicity studies are available via the oral and dermal route. The results show that SDBR is not toxic after single exposure.
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:
- Feb- April 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Version / remarks:
- 1991
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Stability: stable
Solubility: in toluene, methylene chloride
Insoluble: in water
Storage conditions: room temperature - Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, MA, USA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 49 to 74 days old
- Weight at study initiation: 221.9-249.4g (males), 201.3-216.9g (females)
- Fasting period before study: yes, o/n prior to dosing
- Housing: group housed in polycarbonate cages with hardwood chips as contact bedding
- Diet: commercial rodent feed (AgWay Prolab, Waverly, NY), ad libitum
- Water: municipal tap water, ad libitum
There were no known contaminants present in the feed, bedding, or water expected to interfere with the test data.
- Acclimatization period: 6 days
ENVIRONMENTAL CONDITIONS (SET CONDITIONS)
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): minimum 10-13
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30 March 1994 To: 13 April 1994 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: <10 mL/ kg bw
DOSAGE PREPARATION:
The test substance was suspended in corn oil and placed at 70ºC for 60 minutes to allow the test substance to melt. The suspension was cooled at room temperature and the suspension was continuously stirred during the dosing period. - Doses:
- Total dose: 5000 mg/kg bw (animals were dosed twice within a period of 4 hours)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Animals were weighed on Day 7 and on Day 14 prior to sacrifice. At the end of the study, the animals were sacrificed by CO2 inhalation.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No animals died at this dose level during the observation period.
- Clinical signs:
- other: No signs of toxicity were noted throughout the study.
- Gross pathology:
- No unusual lesions were noted in any of the animals at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an acute oral toxicity study in male and female rats, the LD50 was found to exceed 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- One study is available (Klimisch 1 study).
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Density: 1.08 kg/L
Storage conditions: at ambient room temperature - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:(WI) WU BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 194-206g (males), 143-175g (females)
- Fasting period before study: No
- Housing: During exposure period animals were housed individually. - Type of coverage:
- occlusive
- Vehicle:
- maize oil
- Details on dermal exposure:
- After the exposure period materials and residues were removed as much as possible. The animals were observed for mortality for 14 days.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Animals were dosed at 5 mL/kg bw of a 400 mg/mL suspension of the test item.
Body weights were recorded at the start of the study, and on days 3, 7 and 14.
Clinical signs were observed at least once daily (including 1 hour and within 4 hours after dosing), skin effects were evaluated using the Draize system on day 1 after test item removal and on days 3, 7 and 14 of the study.
Gross necropsy was done at sacrifice (carbon dioxide). - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs were observed after treatment of 5 males and 5 females with the 2000 mg/kg bw dose level.
- Gross pathology:
- Macroscopic examination of the animals at the end of the observation period did not reveal treatment-related gross changes.
- Other findings:
- Skin effects observed consisted of very slight erythema and very slight oedema in all treated rats on day 1 of the study. In addition, the 5 females showed very slight scaliness on day 3 of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an acute dermal toxicity study in male and female rats, the LD50 was found to exceed 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One study is available (Klimisch 1 study).
Additional information
Based on the results of an acute oral toxicity study in male and female rats, the LD50 was found to exceed 5000 mg/kg bw. Based on the results of an acute dermal toxicity study in male and female rats, the LD50 was found to exceed 2000 mg/kg bw.
Justification for classification or non-classification
Based on the available results, the test substance is not classified for acute toxicity according to Regulation (EC) No 1272/2008.
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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