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Diss Factsheets
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EC number: 421-080-7 | CAS number: 161462-35-7
- 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 407, EEC B7
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat, Spraque Dawley
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 0.5 % aqueous methylcellulose
- Details on oral exposure:
- Method of administration:
Gavage - Duration of treatment / exposure:
- Test duration: 28 days
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 17.5 mg/kg bw/day
Male: 5 animals at 175 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 17.5 mg/kg bw/day
Female: 5 animals at 175 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
There were no toxicologically meaningful clinical signs or
behavioral abnormalities at 17.5 and 175 mg/kg/day. At the
highest dose level of 1000 mg/kg/day, animals exhibited
treatment-related clinical signs from week 4 of the study.
They consisted mainly of hypersalivation in all animals and
pilo-erection and general pallor in a majority of female
animals. Marked reduced motor activity was also noted in two
females and one female exhibited tremors and prostration.
Laboratory findings:
In hematology no significant changes were observed. In
clinical chemistry treated at 1000 mg/kg/day triglycerides,
bilirubin, urea and albumin concentrations were increased in
females, cholesterol and protein concentrations were
increased in both sexes. In addition, lower glucose
concentration was noted in females.
Effects in organs:
At necropsy, enlarged livers were noted in all males and
females treated at 1000 mg/kg/day. A dose-related higher
liver weight (absolute and relative) was noted at 175 and
1000 mg/kg/day in both sexes. Kidney weight (relative) was
increased in both sexes at 175 and 1000 mg/kg/day and
absolute kidney weight was also noted in males at 175
mg/kg/day.
In microscopic examination revealed in the liver a marked
centrilobular hypertrophy, bile duct hyperplasia,
centrilobular necrosis and fibrosis and periportal
basophilia in males and females treated at 175 and 1000
mg/kg/day. At 1000 mg/kg/day proximal tubular
microvacuolation and cytoplasmic eosinophilia was observed
in both sexes. Chronic cardiomyopathy was noted in a
proportion of male and female rats and increased cortical
vacuolation of the adrenal gland was noted in males treated
at the two highest dose levels.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 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: Xn - harmful
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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