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EC number: 939-525-3 | CAS number: 1471313-03-7
- 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
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Study performed according to OECD Guideline 407 and in compliance with GLP with Klimisch score 1.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a repeated dose oral toxicity study conducted according to the OECD Guideline 407 and in compliance with GLP, the substance administered daily by oral gavage to rats in corn oil for 28 days entailed no mortality. Clinical observations were confined to increased salivation detected in animals of either sex treated with 325 and 1000 mg/kg bw/day throughout the treatment period. Isolated instances of noisy respiration and fur staining around the snout or mouth were also evident in 1-3 animals at 325 and 1000 mg/kg bw/day. No treatment-related changes were detected in functional performance and sensory reactivity. No adverse effects on bodyweight development and food consumption were detected for treated animals when compared to controls. Increased water consumption was detected in animals of either sex treated with 1000 mg/kg bw/day throughout the treatment period and in recovery males during the treatment-free period. No toxicologically significant changes were detected in the haematological, blood chemical and urinalysis parameters measured. Macroscopic examinations revealed a dark liver, evident in three males and two females at 1000 mg/kg bw/day. A statistically significant increase in liver weight, both absolute and relative to terminal bodyweight was evident in animals of either sex treated with 325 and 1000 mg/kg bw/day and in recovery animals following 14 days without treatment. Microscopic examinations of liver sections revealed hepatocellular hypertrophy in animals of either sex treated with 325 and 1000 mg/kg bw/day and in males treated with 35 mg/kg bw/day. Hepatocyte enlargement is commonly observed in the rodent liver following the administration of xenobiotics and, in the absence of associated inflammatory or degenerative changes, is generally considered to be adaptive in nature. Microscopic findings were also evident in the thyroid together with increased absolute and relative thyroid weights for females treated with 1000 mg/kg bw/day. Follicular cell hypertrophy was evident in animals of either sex from all treated groups. The liver and thyroid changes together with associated organ weight changes were considered to be adaptive in nature and do not represent an adverse effect of treatment. The microscopic kidney changes identified as increased severity of hyaline droplets in the proximal tubules of the kidneys were evident in males treated with 1000 mg/kg bw/day together with an increase in absolute and relative kidney weight. Accumulations of globular eosinophilic material in the tubular epithelium is a well documented effect, peculiar to the male rat. Female rats and other species do not develop nephropathy and for this reason, the effect is not indicative of a hazard to human health. The microscopic effects detected in non-recovery animals were observed to have generally or completely regressed among recovery high dose animals following 14 days without treatment.
Under the test conditions, the NOAEL was considered to be 1000 mg/kg bw/day in Wistar rats.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study available.
Justification for classification or non-classification
The NOAEL identified in an oral 28-day repeated toxicity study was 1000 mg/kg bw/day. Therefore the substance is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 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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