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Diss Factsheets
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EC number: 203-404-7 | CAS number: 106-50-3
- 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
90-day oral NOAEL; study equivalent to OECD 408. The mean absolute and body weight-related liver weight were significantly increased for males given 8 mg/kg/day and 16 mg/kg/day. At the same dose levels, absolute and body weight-related kidney weights were increased for females. However, no associated histopathological changes were noted and no treatment macroscopic or microscopic findings were recorded. Therefore, these effects were not considered adverse. Based on these results the NOAEL was 16 mg/kg bw/day (highest dose tested) and the NOEL was established at 4 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 16 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Male and female rats were exposed to the test substance via gavage at doses of 2, 4, 8, or 16 mg/kg/day for 13 weeks. No mortality was observed during the study. No treatment-related effects on clinical signs, body weight changes, food consumption, or ocular changes were observed. Increased mean absolute liver weights (≥8 mg/kg males) and body weight-related liver weights (16 mg/kg males) and increased mean absolute and body weight-related kidney weights (≥8 mg/kg females) were observed. As the increased body weight-related liver and kidney effects had no associated pathological changes (and are considered and adaptive response to dosing), they are not viewed as adverse. No effects were observed at 4 mg/kg/day. Therefore, the no observed effect level (NOEL) for this study was 4 mg/kg/day and the NOAEL was 16 mg/kg/day.
Justification for classification or non-classification
R48/22 classification for the EU Directive 67/548/EEC and STOT Rep Cat 2 classification for the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 was precautionarily indicated because no data exists above 16 mg/kg bw. This classification deviates from that found in 67/548/EEC Annex I.
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.