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EC number: 245-740-7 | CAS number: 23564-05-8
- 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
Administrative data
Description of key information
No test item related neurotoxicity was observed in a subchronic study according to OECD TG 424 in rats. A NOAEL of 149.6 mg/kg bw/day was derived.
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 149.6 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- OECD TG 424
Effect on neurotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on neurotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Neurotoxicity-acute
In an acute neurotoxicity study according OECD TG 424, the substance was administered to male and female Sprague-Dawley (SD) rats (10 rats/sex/dose) by single-dose gavage in 0.5% aqueous methylcellulose. Doses in male and female rats were 0, 500, 1000 and 2000 mg/kg bw (main study) and at 0, 50, 125, 500 and 2000 mg/kg bw (extension study). In the main study, assessments included mortality, clinical signs, body weight, food consumption, functional observational battery (FOB) and motor activity evaluations, brain weight determination as well as macroscopical and neuropathological examinations. In the extension study, -in addition to mortality, clinical signs, body weight and food consumption, - home cage behaviour and landing foot splay (FOB components) in both sexes and motor activity were assessed prior to the administration and 2 hours after the administration of the test substance. No deaths occurred during either the extension study or the main study. Clinical signs included slight excess salivation, localized alopecia, scabs and/or ulcers on the skin, chromorhinorrhea, chromodacryorrhea, swelling of the prepuce, and sparse hair coat. Since the incidences were not dose-dependent and/or occurred in only one to three rats in one or more dose groups; all clinical signs were considered unrelated to the treatment with the test substance. Body weight and food consumption were unaffected at 50 and 125 mg/kg bw in the extension study. Transient reductions in body weight gain or body weight losses along with corresponding reductions in absolute and relative food consumption occurred initially (Days 1-3) in both sexes at 500 mg/kg bw, 1000mg/kg bw and 2000mg/kg bw in both the main and extension study.
In the main study, the FOB examinations conducted two hours after dosage, male and female rats at 500, 1000, and 2000 mg/kg bw had significantly reduced values for landing foot splay. The number of male rats that appeared to be sleeping when examined in the home cage were also significantly reduced and number showing other normal patterns (e.g. appeared awake and immobile or showed normal movement) were increased as compared to the control group. There were neither statistically significant nor exceptional differences among the groups in the measures of the FOB evaluated on the day prior to dosage and day 7 and 14 after dosage.
In the extension study, examinations conducted two hours after dosage, both male and female rats given test item at all doses had significantly reduced values for landing splay. The variations in normal home cage behaviour were not observed at 50, and 125 mg/kg bw and were not replicated at the 500 and 2000 mg/kg bw in the extension study. In the main study there were no statistically significant nor exceptional differences among the groups of male rats, in the motor activity test on the day prior to treatment at 7 and 14 days after administration (days 8 and 15). For female rats (500, 1000, and 2000 mg/kg bw) there were significantly reduced number of movements and time spent in the motor activity test two hours after dosage. The reduced activity was not observed seven days after dosage or 14 days post dosage.
In the extension study, there were no differences in the female rats at any dose 2 hours after dosage. In the main study, no gross lesions were observed at necropsy. Brain weights (absolute, relative) were comparable among the groups. No test substance related lesions were observed in the microscopic examination of neural and muscle tissues. The NOAEL for neurotoxicity was > 2000 mg/kg bw.
Neurotoxicity-subchronic
A study according OECD TG 424 was performed. Ten CD IGS rats/sex/dose group were treated via diet with the test substance at concentrations of 0, 100, 500, and 2500 ppm (males: 6.2, 30.2, and 149.6 mg/kg bw/day, females: 6.8, 34.9, and 166.3 mg/kg bw/day) for 13 weeks. Mortality, clinical observations, body weight, food consumption, and functional observational battery (FOB) and motor activity evaluations were recorded. Rats were sacrificed on day 91. A gross necropsy of the thoracic abdominal and pelvic viscera was performed. Liver, thyroid and individual kidney weights were recorded at necropsy, and brain weights were recorded following additional fixation of the tissue. For neurohistological examination, 5 rats/sex/dose group were selected and the tissues from control and high concentration group rats were evaluated. All rats survived to termination (13 weeks of exposure). Clinical signs included slight excess salivation, red perioral substance, chromorhinorrhea, chromodacryorrhea, misaligned and/or missing or broken incisors, and missing digit, and were considered unrelated to the test item because the incidences were low or, in the case of chromorhinorrhea, had an irregular frequency among individual rats. Body weights, body weight changes, and absolute and relative feed consumption values were significantly decreased at 2500 ppm in female rats (9.4-10.3%; days 71-85) for the entire exposure period, whereas these endpoints were unaffected in male rats. There were no test item-related adverse effects on FOB parameters and motor activity at any dietary concentration in either sex. There were no test item-related macroscopic findings at scheduled necropsy. Liver and thyroid weights were significantly increased in males (absolute, relative) and females (relative) at 2500 ppm. The brain weights of female rats at 2500 ppm (relative) were significantly increased. There were no microscopical lesions in the neural or muscle tissue of the examined control and 2500 ppm rats. The NOAEL for neurotoxicity was > 2500 ppm (males: 149.6 mg/kg bw/day, females: 166.3 mg/kg bw/day). The NOAEL for generalized systemic toxicity was 500 ppm (males: 30.3 mg/kg bw/day, females: 34.9 mg/kg bw/day) based on reduced body weight/body weight gain and food consumption and increased liver and thyroid weights noted at 2500 ppm.
Justification for classification or non-classification
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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