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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 452-190-3 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: crystalline
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- Method of administration:
Gavage - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Test duration: 90 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 10 animals at 50 mg/kg bw/day
Male: 10 animals at 250 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 50 mg/kg bw/day
Female: 10 animals at 250 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
No significant clinically observable signs of toxicity were
detected.
There were no deaths and no treatment related effects on
behavior, functional performance, sensory reactivity,
bodyweight, or food or water consumption.
Laboratory findings:
There were no significant treatment related changes detected
in the haematological parameters measured or in blood
chemistry.
Effects in organs:
No significant treatment related organ weight changes were
detected.
No macroscopic abnormalities were detected at terminal kill.
Trachea: Epithelial deciliation, epithelial hyperplasia and
inflammatory cell infiltration were observed in animals of
either sex treated with 250 mg/kg/day. These and associated
changes are probably a consequence of accidental
instillation into the airways and are unlikely to be a
systemic effect.
Stomach: Agglomeration of secretion was observed in the
gastric mucosa of both sexes treated with 1000 mg/kg/day.
Acanthosis and hyperkeratosis of the epithelium of the
forestomach were also observed. Similar effects were not
seen convincingly at other dose levels.
A malignant tubular carcinoma was observed in the kidney of
one 1000 mg/kg/day female. Due to a lack of any other
findings in the kidneys of other animals this is not
considered to be treatment related effect.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No clinically observable signs of toxicity were detected. There were no deaths, and no treatment-related effects on behaviour, functional performance, sensory reactivity, bodyweight, or food and water consumption.
There were no treatment-related changes detected in the haemaotlogical parameters measured, or in blood chemistry. There were no ocular changes noted by opthalmoscopy.
No treatment-related organ-weight changes were detected. No macroscopic abnormalities were detected at terminal kill.
Trachea: Epithelial deciliation was observed in animals of either sex treated with 1000 mg/kg/day, and for males treated with 250 mg/kg/day. These, and associated changes, are probably a consequence of accidental installation into the airways, and are unlikely to be a systemic effect.
Stomach: Agglomeration of secretion was observed in the gastric mucosa of both sexes treated with 1000 mg/kg/day. Acanthosis and hyperkeratosis of the epithelium of the forestomach were also observed. Similar efects were not seen convincingly at other dose levels.
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified.
Exclusion of the findings associated with irritancy would result in a NOAEL of 1000 mg/kg/day.
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.
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