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Diss Factsheets
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EC number: 947-785-4 | 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
Link to relevant study record(s)
Description of key information
The present assessment of the absorption, distribution, metabolism and excretion of the studies substance is derived from experimental data produced to register the substance.
Toxicity
Acute oral and dermal toxicity studies in rats: in the limit test at a fixed dose of 2000 mg/kg no significant treatment related effects were seen. In such studies LD50 was higher than 2000 mg/kg.
The repeated administration in the 13-week toxicity combined with reproductive endpoint study in rodent by oral did not showed any adverse systemic effects. NOAEL is considered to be 1000 mg/kg/day for males and females. Local effects were seen in lungs but considered an indirect effect due to suspected chemical pneumonitis. It is known that low viscosity chemical can generate residues in the esophagus that can be aspired in the trachea and deposited in lungs creating such local inflammation. Dark material (the test material) seen in some animals in lung histiocytes support such conclusion.
The lack of general effects and of the target organ toxicity does not lead to conclude that the test item is adsorbed and distributed systemically.
No effects were seen for reproductive end-points up to 1000 mg/kg/day, NOAEL for reproduction is therefore set at > 1000 mg/kg/day.
No information is available concerning excretion rates.
Skin and eye irritation did not show any local or systemic toxicity.
In the skin sensitisation study, the test item showed a potential to sensitisation; the substance is therefore considered a skin sensitizer.
Mutagenicity
The test substance was not mutagenic in the bacterial mutation assay and in the "in vitro" chromosome aberration study using CHO, with and without metabolic activation system as well as in the mouse lymphoma test. These studies also demonstrated that no difference of behaviour was noted after metabolic activation of the substance with S9mix. Toxicity is therefore not induced or enhanced by the metabolism of the substance.
Assessment
The effects seen do not suggest a possible absorption by GI tract at given doses; the bioaccumulation evaluation done (see previous paragraph) suggests that the test substance will not bioaccumulate in aquatic organisms and that no secondary poisoning through the food chain may be realistic.
No skin absorption was observed when applied during the acute toxicity studies as no systemic effect were observed.
The test substance is not absorbed systemically and hence could not show toxic potential.
Skin sensitisation study showed a sensitisation potential.
In conclusion, the results of the toxicity studies conducted with the test substance by gavage showed that the substance was not absorbed and distributed systemically, and lack of absorption did not lead to any toxic effect. Lung effects were considered local effects due to chemical pneumonitis and not specific target organ toxicity.
Excretion in urine is not deemed to be realistic as the substance is not absorbed systemically.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 10
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 10
Additional information
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.