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EC number: 944-042-6 | 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
LD50 > 2000 mg/kg b.w.
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:
- November 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Royal Decree 363/1995
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 142.6 males, 128.6 females
- Fasting period before study: overnight
- Housing: Tecniplast Makrolon cage (48 x 27 x 20 cm) with soft wood.
- Diet: free access to a diet for experimental rats, supplied by a authorized provider.
- Water: drinking water ad Iibitum by Makrolon bottles.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C (± 2 °C)
- Humidity: 55 % (± 25 %)
- Air changes: 15ACH filtered at 5 µm
- Photoperiod: 12 hours cycle dark/light. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg of test item were dissolved in 20 ml of distilled water.
- Amount of vehicle: 2 ml per 100g b.w, equivalent to 2000 mg/kg b.w. - Doses:
- 2000 mg/Kg.
- No. of animals per sex per dose:
- 3 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing:at 0, 7 and 14 days.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed.
- Clinical signs:
- No abnormal behaviour or signs of toxicity were observed.
- Gross pathology:
- No macroscopic changes were observed.
- Interpretation of results:
- other: Not classified, accordding to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The substance was tested for acute oral toxicity following EU MEthod B.1 tris. Under the experimental conditions the LD50 > 2000 mg/kg b.w.
- Executive summary:
The substance has been tested for acute toxicity by oral dose according to the Directive 67/548/EC B.1 ter, class method.
A limit test at one dose level of 2000 mg/kg body weight was carried out with six animals. No mortality has been observed until 2000 mg/kg b.w, therefore the LD50 is over than 2000 mg/kg b.w.
Conclusion
LD50 > 2000 mg/kg b.w.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral exposure:
The study was conducted according to the method described into the Directive EC n. 67/548 Annex IV B. B.1 .ter.
The substance has been tested for acute oral administration by gavage. Six rats (3 males and 3 females) were used for the study at concentration of 2000 mg/kg bw.
No clinical symptoms were recorded and no deaths occurred. During autopsy no macroscopic changes were seen.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:
For Acute toxicity oral route:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be > 2000 mg/kg bw which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposureInformation 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.