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Diss Factsheets
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EC number: 908-531-8 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 08-08-2013 to 10-09-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- no data
- EC Number:
- 908-531-8
- Molecular formula:
- No data
- IUPAC Name:
- no data
- Test material form:
- other: liquid
- Details on test material:
- The test item was administered undiluted.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Hannover
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- The rats were housed in groups of three rats per cage, during acclimatization and observation periods, in polypropylene rodents cages (41x34x19 cm) with wire mesh tops and bedding materiak (autocalved wood shavings). The bedding was regularly assayed for contaminants at the analytical laboratories of BIOAGRI Alimentos-SP/Brazil, and was considered to be suitable on the basis of analytical analyses. Results of the analyses are maintained by BIOAGRI and are available for inspection. Clean cages were provided three times per week.
In the experimental room the temperature was within 19.0 °C and 23.0 °C with a relative humidity of 34% - 57.3%, room ventilation set a 10 to 20 air changes per hour and a photoperiod of 12 hours light and 12 hours dark. Environmental control equipments were monitored and adjusted as necessary to minimize fluctuations in the animal room environment.
The food used was autoclaved pelleted diet type for rodents supplied by Supralab which was available ad libitum throughout the study, exept in the fasting period. Filtered drinking water was supplied by CAESB was supplied in water bottles for animals ad libitum. The food and water were regularly assayed for chemical and microbiological contaminants at the analytical laboratories. The food was assayed at BIOAGRI Alimetnos-SP/ Brazil for nutritional composition. Both, food ans water, were found to be suitable on the basis of the analytical analyses and the results are available for inspection.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The animals were fasted overnight before dosing, but had free access to water. On the day of dosing (Day 0), the animals were weighed and individual volume of the test item to be administered was calculated according to individual body weight. The test item was administered orally, by gavage. The maximum volume of test item administered to each animal did not exceed 1mL/100g of body weight.
Food was given back 3 hours after administration of the test item. - Doses:
- 300 and 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 females
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- other: Three females treated with dose of 300 mg/kg body weight, showed piloerection from day of the adiministration of the test item until day 1 of the observation period. Three females treated with dose of 300 mg/kg body weight showed slight apathy from day of
- Gross pathology:
- There were no substance-related macroscopic alterations at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this tudy, the substance is unclassified according to GHS and the estimate acute oral LD50 cut-off value for female rats is 5000 mg/kg body weight.
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