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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
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.
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