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Diss Factsheets
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EC number: 446-570-8 | CAS number: 1127-01-1
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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: OECD 407
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Hsd Cpb:WU
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 2 % Cremophor EL (v/v)
- 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:
Neither daily in-cage observations, nor weekly clinical
examinations including observations in an open field
revealed treatment-related findings in any dose group.
Detailed behavioral investigations (functional obesrvational
battery, assessment of motor activity) gave no evidence for
a neurotoxic potential of the test substance.
Body weight development was not retarded by the treatment
with the test substance up to 1000 mg/kg.
Survival was not affected by the treatment with the test
substance. One female treated at 40 mg/kg/day died during
blood sampling procedure.
Laboratory findings:
The hematological investigations gave no indication of a
test substance related effect on parameters of red and white
blood or on blood coagulation.
Clinical laboratory tests (determination of enzyme
activities, concentrations of substrates and electrolytes in
peripheral blood) revealed no indication of a treatment-
related effect.
Urinalyses showed that in urine of all animals of the
1000 mg/kg group ketone bodies were present, the pH-value
was decreased and fatty droplets were observed in males.
Ketone bodies in the urine were also noted in 3/5 males at
40 mg/kg/d and in 4/5 males and 2/5 females at 200 mg/kg/d.
In the sediment of animals of the high dose group triple
phosphates were not present and bacteria were observed with
lower grading than in other groups or were absent. This was
not regarded as an adverse effect.
Effects in organs:
The ophthalmoscopic examinations afforded no evidence of
treament related effects on eyes.
In males and females of the 1000 mg/kg group an increase in
liver weights was observed. Histopathology revealed no
morphological changes in the liver.
At 200 mg/kg and above females revealed morphological
changes in epilethal cells of the proximal straight tubules
in the corticomedullary kidney region (P3 segment),
increased by incidence and severity. The epithelial cells
appeared to be flattened with a fringy brushborder and the
lumen was dilated. These findings are not regarded as a
damage of the kidneys as signs of cell degeneration or
necrosis were absent.
Gross and histopathological investigations of other organs
and tissues gave no indication of test-compound-related
findings.
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:
- 40 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.
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.
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