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EC number: 946-245-5 | 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
Acute oral toxicity: LD50 was found to be 6.10 g/kg bw for males and 2.35 g/kg for females, tested using a method similar to OECD TG 401
Acute inhalation toxicity: LC50 value of >35000 mg/m³ has been calculated using route to route extrapolation.
Acute dermal toxicity: The dermal LD50 value of the substance was found to be greater than 5.0 g/kg bw day in both sexes tested using a method similar to OECD TG 402
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 350 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The acute inhalation toxicity is derived using route to route extrapolation from the acute toxicity results using 100% absorption. This assessment is considered to be sufficiently adequate to cover this endpoint.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 mg/kg bw
Additional information
Acute oral toxicity study
The acute oral toxicity of the substance was evaluated in male and female Sprague-Dawley derived albino rats (10 animals per sex per dose). The animals were treated with the following dosages: 0.59, 1.00, 1.69, 2.88, and 5.0 g/kg bw by gavage. Gross signs of systemic toxicity, mortality, bodyweight was determined. Gross necropsy was performed after the 14- day observation period. Deaths occurred within six days after treatment. Central nervous system depression was present in all groups after treatment. All animals which survived the observation period gained weight. Necropsies of animals which died revealed staining around the mouth, gas in the intestinal tract and changes in the kidneys and livers in most animals while necropsies of animals at the end of the observation period were generally uneventful. The acute oral LD50 was found to be 6.10 g/kg bw for male Sprague-Dawley derived albino rats with a 95% confidence limit of 3.51 - 10.6 g/kg. The slope was found to be 2.45 for the males. The LD50 for female Sprague-Dawley derived albino rats was found to be 2.35 g/kg bw with a 95% confidence limit of 1.31 - 4.21 g/kg. The slope was found to be 4.45 for the females.
Inhalation route:
The acute oral toxicity does not indicate a hazard classification for the inhalation route because the LD50 is > 5000 mg/kg bw corresponding to the cut off value for vapours LC50 > 20000 mg/m3 (EU-CLP, 2009). This also indicates that the substance does not need to be classified for acute inhalation because the bioavailability via all routes will be similar. As a worst case approach the bioavailability via the inhalation route may be twice as high. For excluding the need to C&L for acute inhalation we quantified the substance concentration in the air. An oral LD50 of 5000 mg/kg bw can be roughly converted into 350000 mg/per person by multiplying it with a person’s weight (70 kg: 5000 x 70=350000). An inhalation volume for one person during 4 h (standard exposure time in the OECD TG for acute inhalation) is 5 m3 (assuming 10 m3/8h for workers). This means that an LC50 concentration in 1m3air and 4 hours exposure is 70000 mg/m3 (350000 mg/5m3). Taking into account that the absorption for the inhalation route can be twice as high as that for the oral route (based on default absorption values mentioned in REACH guidance R.8.4.2), the LC50 for inhalation would become (70000/2=) 35000 mg/m3. The maximum saturated vapour pressure for the substance is 7361 mg/m3 (calculated as: 100 Pa [vapour pressure] x 182.07 [MW, g/mole] x 1000 [conversion from g to mg] / 8.3 [R, gas constant] x 298 K [temperature pertaining to the vapour pressure]). This means that the substance cannot reach a concentration higher than 7361 mg/m3. Therefore, the calculated LC50 for inhalation (35000 mg/m3) cannot be reached and no classification and labelling is needed for the acute inhalation route.
Acute dermal toxicity
The dermal LD50 determination in male and female Sprague-Dawley derived albino rats of the substance was performed. Groups of ten male and ten female Sprague-Dawley rats received a single dermal dosage of the substance dissolved in a diluent. Dosages were 0.59, 1.0, 1.69, 2.88 and 5.0 g/kg bw day. All animals were observed for mortality and signs of toxicity. At the end of the 14-day observation period, the rats were weighed and sacrificed. Results showed that there was no mortality, no clinical signs observed during the 14- day observation period. At termination, gas in the intestines was observed in most of the males and a few females. No gross pathology was noted. All rats gained weight during the observation period. The dermal LD50 value of the substance was found to be greater than 5.0 g/kg bw day in both sexes.
Justification for classification or non-classification
Based on the oral LD50 of 2350 mg/kg bw and the dermal LD50 >5000 mg/kg bw, the substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) 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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