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Diss Factsheets
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EC number: 425-030-5 | CAS number: 159939-85-2
- 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
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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-guideline No. 407 (May 12, 1981. Adopted) EEC Directive 67/548/EEC
- GLP compliance:
- yes
- Limit test:
- yes
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- 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 20 mg/kg bw/day
Male: 5 animals at 80 mg/kg bw/day
Male: 5 animals at 320 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 20 mg/kg bw/day
Female: 5 animals at 80 mg/kg bw/day
Female: 5 animals at 320 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
T001625 did not lead to adverse effects on clinical
behaviour and physical appearance in Wistar rats when dosed
by oral gavage at 20 and 80 mg/kg body weight/day for 28
days. Salivation was noted at 320 mg/kg body weight/day.
Opthalmoscopic examination did not reveal any abnormalities.
There was no relevant adverse effect on body weight and body
weight gain.
Laboratory findings:
T001625 did not produce relevant adverse effects on
haematological parameters. A decrease in haematocrit in
males at 80 and 320 mg/kg body weight/day and a decrease in
haemoglobin and red blood cells in males at 80 mg/kg body
weight/day and in males and females at 320 mg/kg body
weight/day are considered drug-related.
There was no relevant adverse effect on biochemical
parameters in male and female rats dosed up to 320 mg/kg
body weight/day.
There was no relevant adverse effect on urinary parameters
when dosed by oral gavage at 20 and 80 mg/kg body weight/day
for 28 days. A decrease in creatinine at 320 mg/kg body
weight/day is considered drug-related.
Effects in organs:
There were no relevant adverse effects on organ weights of
male Wistar rats when dosed by oral gavage at 20 and 80
mg/kg body weight/day. An increase in absolute and relative
weight of the liver in females dosed at 320 mg/kg body
weight/day and of the adrenals in all T001625-dosed females
and males dosed at 320 mg/kg body weight/day is considered
drug- and dose-related.
There were no macroscopic changes, except for the presence
of swollen adrenals in one male at 320 mg/kg body weight/day
and in females dosed at 80 mg/kg body weight/day.
In males dosed at 320 mg/kg body weight/day drug-related
changes were adrenocortical hypertrophy and hepatocytic
swelling. Drug- and dose-related changes in female rats
were adrenocortical hypertrophy (all dose levels), ovarian
changes (80 and 320 mg/kg body weight/day), hepatocytic
swelling and vacuolation, and hyperplasia of the splenic red
pulp (320 mg/kg).
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 80 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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