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Diss Factsheets
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EC number: 425-000-1 | CAS number: 61718-80-7
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to recommended guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 20% ethanol in corn oil.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
15
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
50
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
150
Basis:
actual ingested
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 50 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 15 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Clinical observations: No deaths occurred at any dose Clinically, fur loss was seen in 2 out of 5 females treated at 150 mg/kg/day from week 3 of the treatment period onwards
- Mortality:
- no mortality observed
- Description (incidence):
- Clinical observations: No deaths occurred at any dose Clinically, fur loss was seen in 2 out of 5 females treated at 150 mg/kg/day from week 3 of the treatment period onwards
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Females treated at 150 mg/kg/day showed a lower mean body weight starting from the third week of dosing, with a reduction of about 8% in comparison to the controls at the end of the study
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No important variations were noted at any dose. A possible minor treatment-related change was a decrease in platelet value for both sexes treated at 150 mg/kg/day
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The possibly minor treatment-related effects were increases in serum triglyceride level and in alkaline phosphatase activity in both sexes treated at 150 mg/kg/da
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical observations:
No deaths occurred at any dose
Clinically, fur loss was seen in 2 out of 5 females treated at 150 mg/kg/day from week 3 of the treatment period onwards
No effects on body weight growth or food consumption were found in either sex treated at 15 and 50 mg/kg/day or in males given the high dose (150 mg/kg/day). Females treated at 150 mg/kg/day showed a lower mean body weight starting from the third week of dosing, with a reduction of about 8% in comparison to the controls at the end of the study
No eye modifications were noted
Laboratory findings:
No important variations were noted at any dose. A possible minor treatment-related change was a decrease in platelet value for both sexes treated at 150 mg/kg/day
No changes of note were seen in animals treated at 15 and 50 mg/kg/day
The possibly minor treatment-related effects were increases in serum triglyceride level and in alkaline phosphatase activity in both sexes treated at 150 mg/kg/day
No treatment-related modifications were seen
Effects in organs:
No treatment-related changes were noted
HISTOLOGY
Treatment-related changes associated with daily oral administration of the test article were limited to the anterior lobe of the pituitaries of male rats treated with the high dose, consisting of increased presence of cells having vacuolated cytoplasm
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Females treated at 150 mg/kg/day showed a lower mean body weight starting from the third week of dosing, with a reduction of about 8% in comparison to the controls at the end of the study
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for specific target organ toxicity following repeated exposure.
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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