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Diss Factsheets
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EC number: 456-080-6 | 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:
- repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 407 (1995) Siehe Bemerkungen.
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Hsd Cpb:WU
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Wasser
- Details on oral exposure:
- Method of administration:
gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 40 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 40 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
During the study no animal died unscheduled.
The body weight gain and food intake were not affected up to
1000 mg/kg. No clinical findings were observed at cage side
detailed weekly clinical observations up to 1000 mg/kg.
Laboratory findings:
Hematology revealed no signs indicating hematoxicity up to
1000 mg/kg.
Up to 1000 mg/kg none of the plasma enzymes, substrates or
electrolytes was affected.
Effects in organs:
Treated females exhibited a pale discoloration of the liver
more frequently than at 0 mg/kg. Furthermore, in the kidneys
a pale discoloration was observed in males and females of
all dose groups. The incidences were in males 0-1-2-4 and in
females 0-3-4-4. No other macroscopical lesions with a
dose-dependent distribution were seen.
A minimal to slight hepatocellular cytoplasmic charge (1-4-
4-4) occurred in treated females with a higher frequency
than at 0 mg/kg. This change consisted of a denser cytoplasm
and could be correlated to a lower glycogen content. Often,
a correlation between this finding and gross discoloration
was present. There was no evidence of any toxic effect on
the liver. In particular, no degenerative liver change could
be found up to and including 1000 mg/kg. The investigation
of Oil-Red O (ORO) stained cryocuts of the liver gave an
increased incidence of minimal lipid in mid dose males.
Since this finding was unrelated to dosing with the test
compound, it is regarded as a random event.
There was no evidence of any substance-induced finding in
the kidneys up to 1000 mg/kg, which could be seen as a
correlate to the pale discolored kidneys ovserved at
necropsy.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 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
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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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