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Diss Factsheets
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EC number: 480-340-8 | 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
Endpoint summary
Administrative data
Description of key information
LD50 (oral) > 2000 mg/kg b.w.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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
Acute oral toxicity
The acute oral toxicity of the test material in the female Sprague-Dawley strain rat was assessed in this limit acute toxic class test coducted according to the OECD Guideline 423 and EU Method B.1 tris. For this reason, three female rats were used in each step and they were given one single oral dose of the substance at dose level of 2000 mg/kg b.w. The animals were observed for fourteen days for signs for clinical signs, toxicity and for deaths. Body weights were recorded prior to dosing, weekly thereafter and at the end of the test. At the end of the test the survived animals were killed and were subjected to gross pathological examination.
No mortality occured and no macroscopic changes were observed. The animals showed normal bodyweight gain in bodyweight. The only observation was the decrease of spontaneous activity in the treated animals (6/6) from 3 hrs after administration. However, the animals recovered a normal activity the 2nd day of the test. LD50 > 2000 mg/kg b.w.
Acute inhalation toxicity
The substance has a low volatility (V.P.< 0.5 kPa) and does not present any inhalable/respirable particles. In humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50 µm may reach the thoracic region and those below 15 µm the alveolar region of the respiratory tract. Τhe substance does not contain any particles with a diameter less than 15 μm. Furthermore, no systemic toxicity occurred during the acute oral toxicity test; the absence of systemic toxicity and the absence of other data that could indicate the potential for absorption following ingestion, support the idea that it is unlikely that the substance will be absorbed in case it is inhaled. The properties of the substance and the absence of systemic toxicity in the oral toxicity test indicate that human exposure is not possible via inhalation, therefore testing via this route for acute toxicity should not be conducted.
Acute dermal toxicity
The physicochemical properties of the substance suggest a low dermal absorption in case of dermal exposure. In addition, the absence of systemic toxicity and mortality in the available in-vivo studies (skin sensitisation and acute oral toxicity) permit the waiving of the acute dermal toxicity test. Furthermore, in a study by Moore et al. (2013) the acute systemic toxicity data (LD50 values) and hazard classifications derived in the rat following oral administration and dermal application have been analysed to examine whether or not orally-derived hazard classification or LD50 values can be used to determine dermal hazard classification. The authors suggest that no substance (out of the 355 substances reviewed) with an oral LD50 of >2000 mg/kg was classified for acute systemic toxicity by the dermal route, suggesting that dermal testing for acute systemic toxicity of such substances adds nothing to the hazard characterisation and should be removed from routine regulatory data requirements.
Moore, N. P., Andrew, D. J., Bjerke, D. L., Creton, S., Dreher, D., Holmes, T., Prieto, P., Seidle, T. and Rowan, T.G. (2013). Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).Regulatory Toxicology and Pharmacology, 66(1), 30-37.
Justification for classification or non-classification
The LD50 of the substance found in the limit test in the acute oral toxicity study was greater than 2000 mg/kg bw.
The LD50 of the tested substance is greater than 2000 mg/kg bw, it doesn't meet the classification criteria of the CLP regulation n. 1272/2008, and thus is not classified for acute toxicity.
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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