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Diss Factsheets
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EC number: 813-349-6 | CAS number: 56289-56-6
- 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: OECD TG 401: 1520 mg/kg bw.
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:
- Not reported.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No details on test material, no purity, no doses/dose volume reported, limited details on test animals and no details on environmental conditions, no individual data.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: approximately 18 hours prior to treatment
- Diet: Food was replaced in cages as soon as animals received their respective doses.
- Water: Free access to water
ENVIRONMENTAL CONDITIONS
No data. - Route of administration:
- other: oral intubation
- Vehicle:
- unchanged (no vehicle)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. - Statistics:
- LD50 values were computed by the method of Litchfield & Wilcoxon (1949).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 520 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 790 - <= 1 290
- Mortality:
- Yes, death time 4 hours - 8 days.
- Clinical signs:
- Scrawny appearance.
- Body weight:
- No data.
- Gross pathology:
- No data.
- Interpretation of results:
- other: Acute harmful Category 4.
- Remarks:
- According to EU CLP (EC No. 1272/2008 and its amendments).
- Conclusions:
- The acute oral toxicity test showed a calculated LD50 of 1520 mg/kg bw.
- Executive summary:
In this study performed equivalent to OECD TG 401 guideline without GLP, rats (5 males and 5 females) were administered with the substance. Death time was 4 hours - 8 days. Clinical signs observed was scrawny appearance. The acute oral LD50 for the substance in male and female rats was calculated to be 1520 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 520 mg/kg bw
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Additional information
Acute oral:
In this study performed equivalent to OECD TG 401 guideline without GLP, rats (5 males and 5 females) were administered with the substance. Death time was 4 hours - 8 days. Clinical signs observed was scrawny appearance. The acute oral LD50 for the substance in male and female rats was calculated to be 1520 mg/kg bw.
Justification for classification or non-classification
Based on the results, the substance needs to be classified for acute oral toxicity category 4 and shall be labelled with H302: Harmful if swallowed according to EU CLP (EC No. 1272/2008 and its amendments).
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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