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Diss Factsheets
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EC number: 444-350-6 | CAS number: 133413-70-4
- 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
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.7; OECD 407 (1981) (siehe Bemerkung)
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar
Administration / exposure
- Route of administration:
- oral: unspecified
- Details on oral exposure:
- Method of administration:
Futter - 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 28.8 mg/kg bw/day
Male: 5 animals at 123.6 mg/kg bw/day
Male: 5 animals at 479 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 31 mg/kg bw/day
Female: 5 animals at 130.8 mg/kg bw/day
Female: 5 animals at 569.4 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
No mortality occurred during the study period.
There were no treatment-related clinical signs in any dose
group and no effect on food and water consumption.
Laboratory findings:
There were no treatment-related effects on hematology and
urinalysis which could be considered of biological
significance.
Clinical biochemistry revealed the liver as target organ.
There were increases in the activity of plasma aline
aminotransferase of male and female rats at 1,200 and 4,800
ppm. An increase of aline aminotransferase was also noted in
females at 300 ppm. However, that was not corroborated by
findings of the additional study. In addition at 1,200 and
4,800 ppm, an increased activity of alkaline phosphatase was
observed in animals of both sexes. There was also an
increase of alkaline phosphatase in male rats at 300 ppm,
while this finding was not confirmed in the opposite sex,
neither in the main study nor in the additional study. It
was considered incidental.
In the hepatic tissue, an increase of the activity of the
N-Demythylase and of Cytochrom P-450 was found in males
treated at 4,800 ppm. This effect is taken as evidence for a
mild induction of the mixed-function oxidases.
Effects in organs:
At 4,800 ppm female rats showed an increase in relative
liver weight when compared with controls.
Histopathology revealed an increased eosinophilia of
centrolobular hepatocytes in 2 of 5 male rats at 4,800 ppm.
Such findings are known to be an adaptive phenomenon as a
result of enzyme induction.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 28.8 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 28.8 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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