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Diss Factsheets
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EC number: 432-090-6 | 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: Commission Directive 92/69/EEC, B7
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Arachis oil BP
- 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 1.5 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 1.5 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 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 male treated with 15 mg/kg/day was found dead at the
start of Day 2.
Clinical Observations:
Blue staining was apparent on the cage tray-liners of 150
mg/kg/day animals from Day 3 onwards and incidents of
increased salivation were detected either pre-dosing or up
to two minutes after dosing from Day 17 onwards.
No such observations were detected at other dose levels.
Bodyweight:
Males treated with 150 mg/kg/day showed a slight reduction
in bodyweight gain throughout the study period compared with
that of controls.
Females from this dose group and animals of either sex
treated with 15 or 1.5 mg/kg/day showed no adverse effect on
bodyweight development.
Food Consumption:
A slight reduction in food consumption was detected for
males treated with 150 mg/kg/day from Week 2 onwards.
No such effect was detected for 150 mg/kg/day females or
animals of either sex treated with 15 or 1.5 mg/kg/day.
Water Consumption:
No intergroup differences were detected.
Functional observations:
A statistically significant reduction in forelimb grip
strength was detected for females treated with 150 and 1.5
mg/kg/day compared with that of controls.
Laboratory findings:
Haematology:
A statistically significant increase in clotting
[prothrombin] time was detected for 150 and 15 mg/kg/day
females when compared with controls. The dose response,
however, was unconvincing and therefore the effect was not
considered to be a toxic one.
Blood Chemistry:
Animals of either sex treated with 150 mg/kg/day showed a
statistically significant increase in plasma bilirubin
compared with that of controls. There was also a
statistically significant decrease in aspartate amino
transferase in males treated with 150 mg/kg/day. The effect
was not seen in female animals.
Effects in organs:
Necropsy:
No treatment-related macroscopic abnormalities were
detected.
The decedent from the 1.5 mg/kg/day dose group showed
reddened lungs and a dark liver.
Organ Weights:
There was no organ weight changes that could be considered
to be a toxic effect. However, a slight but statistically
significant reduction in ovary weight, relative to body
weight, was detected for females treated with 15 mg/kg/day.
Histopathology:
No treatment-related microscopic changes were observed.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1.5 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: 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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