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Diss Factsheets
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EC number: 478-250-9 | CAS number: -
- 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: Annex V
- GLP compliance:
- yes
Test animals
- Species:
- other: Rat, Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 1% w/v methylcellulose in water
- 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 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 300 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 300 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
There were no unscheduled deaths.
Clinical signs of toxicological importance comprised
partially closed eyelids, hunched posture and piloerection,
which were observed in both sexes receiving 300 mg/kg/day
and underactive behaviour which was observed in females
receiving 300 mg/kg/day.
300 mg/kg/day had a higher than control food intake.
Laboratory findings:
Hindlimb grip strength values for males and females
receiving 300 mg/kg/day were low when compared with
controls.
When compared with controls lower motor activity was
recorded for both sexes receiving 300 mg/kg/day and males
receiving 150 mg/kg/day.
Lower overall bodyweight gains and food intake were evident
for males at 300 mg/kg/day, whilst females at 150 or 300
mg/kg/day showed higher weight gains and females dosed with
300 mg/kg/day had a higher than control food intake.
Lower than control creatinine values and higher than control
glucose values were recorded for all treated male groups.
Mean creatinine values for females receiving 300 mg/kg/day
were also lower than controls. Lower than control group mean
cholesterol values were recorded for both sexes receiving
300 mg/kg/day. In addition lower than control total protein
(due to both a lowering in albumin and globulin) was
recorded for females receiving 300mg/kg/day, with lower
globulin also being apparent in males at this dose level.
Effects in organs:
Heavier than control group bodyweight-adjusted mean kidney
weights were recorded for both sexes receiving 150 or 300
mg/kg/day. Males at this dose level also showed elevated
bodyweight-adjusted mean liver weight compared with
controls. Heavier than control mean adrenal weight was
recorded for both sexes receiving 300 mg/kg/day.
The macroscopic examination performed at termination
revealed a higher incidence of enlargement in the adrenals
of female rats treated with 300 mg/kg/day.
Treatment with 300 mg/kg/day was associated with cortical
hypertrophy and hyperplasia in the adrenals of female rats,
an increased degree of aggregations of foamy alveolar
macrophages in the lungs of male and female rats and
extramedullary haemopoiesis in spleen of female rats.
Treatment with 150 mg/kg/day was associated with cortical
hypertrophy in the adrenals and extramedullary haemopoiesis
in the spleen of female rats. Treatment with 15 mg/kg/day
was associated with cortical hypertrophy in the adrenals of
female rats.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 15 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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