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Diss Factsheets
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EC number: 433-890-8 | CAS number: 2040-90-6
- 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
- Limit test:
- no
Test animals
- Species:
- other: Rat (wistar Crl:(WI) BR)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- propylene glycol
- 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 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Mortality data:
There were no treatment-related deaths during the study. One
control female died during blood sampling on the final day
of the study.
Clinical observation:
There were no clinical signs of toxicity or behavioural
changes over the 28-day observation period that were
considered to be related to treatment.
Slight post-dosing salivation occurred in all males and
females of group 4 and one group 3 male in week 3 and/or
4.Incidental findings that were noted included alopecia,
rales, scabs and wounds.
Functional observation
No changes were observed in hearing ability, pupillary
reflex, static righting reflex and grip strength in the
animals treated, when compared with the performance of the
control animals. The variation in motor activity did not
indicate a relation with treatment.
Body weight
Females of group 4 (500 mg/kg) showed a reduced body weight
gain (by approximately 5%) during the final week of
treatment. Some individual body weight values of the treated
males were considered to be high when compared to those of
the control males, resulting in a statistically significant
increased (by approximately 9%) body weight gain for group 3
animals in week 3.
Laboratory findings:
Haematology:
There were no haematological or clinical chemistry changes
that could be considered toxicologically significant.
Clinical biochemistry:
Statisticaly significantly higher values were recorded for
patassium in males of group 4 (500 mg/kg).
Effects in organs:
Macroscopic examination:
Macroscopic observations at necropsy did not reveal any
alterations that were considered to have arisen as a result
of treatment.
Organ weights:
Higher mean absolute (26% increase) and relative (17%
increase) spleen weights were noted for males (26% increase)
recieving 500 mg/kg/day.
Microscopic examination:
There were treatment-related microscopic findings in the
forestomach at 500 mg/kg/day: minimal erosion (2/5 males)
and minimal epithelial hyperplasia (3/5 males and 2/5
females) of the forestomach.
Minimal/slight tubular atrophy was present in the testes of
a proportion of treated animals from all 3 dose groups
(50mg/kg/day and above).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- < 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 50 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
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