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Diss Factsheets
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EC number: 210-498-3 | CAS number: 616-91-1
- 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
According to the available literature, the oral LD50 of the test substance is above 3000 mg/kg bw in mouse and above 5050 mg/kg bw in rat (reference 7.2.1 -1 to 7.2.1 -6).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch Code 4
Additional information
The available in vivo data on mice and rats (publications) were used to assess the acute oral toxicity in a weight of evidence approach. In a metabolism, pharmacokinetic and toxicity study in rats (reference 7 .2.1 -1), an LD50 of > 6000 mg/kg bw was determined. In mice, an LD50 of 7888 mg/kg bw was determined (reference 7.2.1 -2). In other studies, comparable LD50 values were determined in mice (LD50 = 6400 mg/kg bw; reference 7.2.1 -6, LD50 = 4400 mg/kg bw; reference 7.2.1 -4, LD50 > 3000 mg/kg bw, reference 7.2.1 -5) or rats (LD50 = 5050 mg/kg bw; reference 7.2.1 -3, LD50 > 6000 mg/kg bw; reference 7.2.1 -5), respectively. Since all available data indicate a low acute oral toxicity potential of the test item in different species, the whole data set is regarded as sufficient to cover the endpoint acute oral toxicity. Accordingly, the test item is considered to be classified as UN GHS No Category. Therefore no in vivo study was performed recently. This decision is in line with REACH Regulation (EG) No 1907/2006, Annex XI (1) and in the interests of animal welfare (avoidance of unnecessary in vivo experiments).
In conclusion, the determined high LD50 values of the test item indicate a low toxicity and do not warrant a classification for acute oral toxicity (UN GHS: No Category).
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test data are suitable for classification
purposes under Regulation 1272/2008 (CLP). As a result the test item is
not considered to be classified for acute oral toxicity under Regulation
(EC) No 1272/2008, as amended for the tenth time in Regulation
(EU) No 2017/776.
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.