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EC number: 227-367-1 | CAS number: 5807-14-7
- 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
ORAL
LD50 550 mg/kg bw, Sprague-Dawley rat, OECD 425
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 550 mg/kg bw
- Quality of whole database:
- There are two studies available to address this endpoint. Both are guideline studies conducted under GLP conditions and awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). The quality of the database is therefore considered to be high.
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
There are two studies available; one was conducted on commercially purchased material and the other was conducted using material manufactured by the registrant to confirm the parity of the two materials. On this basis, the study performed using the material manufactured by the registrant was selected as key.
The key study was performed to assess the acute oral toxicity of the test material manufactured by the registrant in the Sprague-Dawley strain rat using the up and down procedure. It was conducted in accordance with the standardised guideline OECD 425 under GLP conditions.
A total of six female animals were dosed individually in sequence with sufficient time (at least 48 hours) between each animal, at dose levels ranging from 175 mg/kg body weight to 2000 mg/kg body weight.
The test material was administered orally by gavage as a solution in distilled water. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
The animal treated at a dose level of 2000 mg/kg and one animal treated at a dose level of 550 mg/kg were found dead on the day of dosing. One other animal treated at a dose level of 550 mg/kg was killed in extremis four hours after dosing. There were no deaths at a dose level of 175 mg/kg.
Signs of systemic toxicity noted in the animal treated at a dose level of 2000 mg/kg were hunched posture, ataxia, ptosis, occasional body tremors and cyanosis. Signs of systemic toxicity noted at a dose level of 550 mg/kg were hunched posture, lethargy, ataxia, ptosis, pilo-erection, decreased respiratory rate, laboured and noisy respiration, occasional body tremors, pallor of the extremities, emaciation, fasciculations and red/brown staining around the snout. There were no signs of systemic toxicity noted in one animal treated at 550 mg/kg and in the animals treated at the dose level of 175 mg/kg. Surviving animals showed expected gains in body weight.
At necropsy, abnormalities noted in animals that died or were humanely killed during the study were dark liver, gaseous stomach, clear liquid present in the stomach and haemorrhagic gastric mucosa and non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Under the conditions of this study, the acute oral LD50 of the test material was determined to be 550 mg/kg bodyweight (95 % confidence limits 88.94 to 2430 mg/kg bodyweight). In accordance with EU criteria, the test material requires classification for Acute Toxicity as Category 4.
The acute oral toxicity of the commercially purchased test material was assessed in a supporting study conducted under conditions of GLP and in accordance with the standardised guideline OECD 425.
A single oral dose of the test material in corn oil was administered by gavage to a total of six female Sprague-Dawley CD rats. The animals were dosed individually in sequence with sufficient time (at least 48 hours) between each animal, at dose levels ranging from 175 mg/kg bodyweight to 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
The single animal treated at a dose level of 2000 mg/kg and two of the three animals treated at a dose level of 550 mg/kg were found dead during the day of dosing. Both animals treated with 175 mg/kg survived.
Signs of systemic toxicity noted in the two animals treated at a dose level of 550 mg/kg that died were hunched posture, lethargy and decreased respiratory rate with ataxia and occasional body tremors. Furthermore, ptosis was noted in one animal. There were no signs of systemic toxicity noted in the surviving animal treated at a dose level of 550 mg/kg and animals treated at a dose level of 175 mg/kg.
Abnormalities noted at necropsy of the animals treated at a dose level of 550 mg/kg that died during the study were haemorrhagic lungs, dark liver, dark kidneys and haemorrhagic gastric mucosa. No abnormalities were noted at necropsy of the animal treated at a dose level of 2000 mg/kg that died during the study or animals that were killed at the end of the study.
The surviving animals showed expected gains in bodyweight over the study period.
Under the conditions of this study, the acute oral LD50 of the test material was determined to be 550 mg/kg bodyweight, based on an assumed sigma of 0.5 (95 % confidence limits 89 to 2430 mg/kg bodyweight). In accordance with the EU CLP criteria, the test material requires classification as Acute Toxicity, Category 4.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance requires classification with respect to acute toxicity as Category 4 (H302 Harmful if swallowed).
In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance requires classification with respect to acute toxicity as R22 Harmful if swallowed (Xn).
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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