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Diss Factsheets
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EC number: 485-390-4 | 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
In a GLP-study according to OECD test guideline 408 (90-days rat study, oral gavage), the NOEL of the registered substance was determined as 1000 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
For the registered substance, one repeated dose study was available. As this study was conducted under GLP-conditions according to an OECD test guideline, it was considered as reliable, i.e. Klimisch 1.
The systemic toxicity of the registered substance was examined in a 90 -day oral gavage study in rats according to OECD test guideline 408 and to GLP. The rats were treated daily with 100, 300 or 1000 mg/kg bw/day. No mortality occured. No influence on the behaviour or external appearance was observed. Body weight and body weight gain, food and drinking water consumption, haematological and biochemical parameters were comparable to control. No effect on the eyes, the oestrus cycle and the spermatogenesis was observed. Histopathology did not reveal any test substance related changes.
The male and female animals treated with 300 or 1000 mg/kg bw/day revealed a dose dependent decrease of urinary pH value by up to 11 % (statistically significant at p ≤ 0.01 for males of both dose levels and for the female at the high dose). This effect is considered to potentially caused by the low pH of the registered substance or by a metabolite eliminated at large doses via the urine.
Treatment with 1000 mg/kg bw/day caused an increase in the absolute and relative liver weights (both sexes). The increase is considered to be a non-specific adaptive change to the high work load of the liver caused by a dose level of 1000 mg/kg b.w./day.
Therefore, the NOEL for systemic changes of the registered substance was determined as 1000 mg/kg bw/day (LPT, 2006).
Justification for classification or non-classification
The test item did not induce adverse effects indicative of serious damage at dose levels relevant for classification and labelling when tested for oral repeated dose toxicity. Thus, the test item is not subjected to classification and labelling for repeated dose toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS, CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.