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EC number: 471-920-1 | 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
Oral administration of the test material to rats for a period of twenty-eight consecutive days at dose levels of 1000 mg/kg/day did not result in any toxicologically significant changes. The ‘No Observed Effect Level’ (NOEL) was considered to be 1000 mg/kg/day.
Further 90-day repeat dose studies in the rat are scientifically unjustified as the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day limit test.
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:
- subacute
- Species:
- rat
Additional information
There is one key 28-day repeat oral dose study.
In a study performed according to OECD 407, EU Method B7 and Japanese Guidelines, the test material was administered by gavage to three groups, each of five male and five female Sprague-Dawley Crl:CD@ (SD) IGS BR strain rats, for up to twenty-eight consecutive days, at dose levels of 25, 250 and 1000 mg/kg/day. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP). Two recovery groups, each of five males and five females, were treated with the high dose (1000 mg/kg/day) or the vehicle alone for up to twenty-eight consecutive days and then maintained without treatment for a further fourteen days.
Clinical signs, bodyweight development and food and water consumption were monitored during the study. Haematology, blood chemistry and urinalysis were evaluated for all non-recovery group animals at the end of the treatment period and for all surviving recovery group animals at the end of the treatment-free period.
All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from non-recovery high dose and control animals was performed.
Mortality. One control male was killed on humane grounds due to the severity of its clinical observations on Day 26. There were no other unscheduled deaths during the study.
Clinical Observations. No clinically observable signs of toxicity were detected throughout the study period.
Behavioural Assessment.Weekly behavioural assessments revealed no treatment-related changes in the parameters measured.
Functional Performance Tests. There were no treatment-related changes in the functional performance parameters measured.
Sensory Reactivity Assessments. There were no treatment-related changes in sensory reactivity.
Bodyweight.No adverse effect on bodyweight or bodyweight gains were detected.
Food Consumption. No adverse effect on dietary intake or food efficiency was detected.
Water Consumption. Daily visual inspection of water bottles revealed no intergroup differences.
Haematology.There were no toxicologically significant changes in the haematological parameters investigated.
Blood Chemistry.There were no toxicologically significant effects on the blood chemistry parameters investigated.
Urinalysis. No treatment-related urinalytical effects were detected.
Organ Weights. No toxicologically significant treatment-related organ weight changes were detected.
Necropsy. No treatment-related macroscopic abnormalities were detected.
Histopathology. No treatment-related changes were detected.
Conclusion.
Oral administration of the test material to rats for a period of twenty-eight consecutive days at dose levels of 1000 mg/kg/day did not result in any toxicologically significant changes. The ‘No Observed Effect Level’ (NOEL) was considered to be 1000 mg/kg/day.
Justification for classification or non-classification
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for subacute repeat oral dose toxicity in the absence of systemic toxicity at the maximum dose concentration.
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