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EC number: 226-901-0 | CAS number: 5538-94-3
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 July 1998 - 16 January 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 451 - Carcinogenicity Studies
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 7173-51-5
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: B-1889
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: the stability of the substance was verified at before the inititation of the study and upon completion of the study.
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Experimental diets were analysed using a gas chromatography procedure. Homogeneity of the substance at each diet concentration was established. Prior to dosing, stability of the test substance in diets at the 100 and 1000 ppm concentrations was determined in stainless steel feeders and in the polyethylene storage containers. Diet concentrations were verified for all dose levels for the first four weeks of the study prior to administration of the diets to the animals. Thereafter, diets prepared every fourth week were analysed for concentration verification.
- Duration of treatment / exposure:
- Eighteen months.
- Frequency of treatment:
- Daily.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 100 ppm
- Dose / conc.:
- 500 ppm
- Dose / conc.:
- 1 000 ppm
- No. of animals per sex per dose:
- Sixty/sex/dose
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily, except for when detailed clinical observations were made.
- Cage side observations checked in table 2 were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a week.
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly for the first 14 weeks and every other week thereafter.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- How many animals:10 animals/sex from the high dose and control groups during week 52; 10 animals/sex from all dose groups during week 79.
- Parameters were examined: erythrocyte count, haemoglobin, haematocrit, erythrocyte indices, platelet count, total leukocyte count. - Sacrifice and pathology:
- Following the 78-week treatment period, the terminal necropsy of all surviving animals was undertaken. A complete necropsy was performed on each animal.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- The incidence of mortality for male mice (including those sacrificed moribund but excluding cage accidents) in the 0 (first control), 100, 500, 1000 and 0 (second control) ppm groups was 22%, 20%, 23%, 22% and 32%, respectively.
The incidence of mortality for female mice (including those sacrificed moribund but excluding cage accidents) in the 0 (first control), 100, 500, 1000 and 0 (second control) ppm groups was 28%, 20%, 25%, 20% and 17%, respectively. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean absolute body weights and body weight gains for male mice in the top dose group were decreased relative to the untreated controls during most of the treatment period. The mean absolute body weights and body weight gains for female mice in the top dose group were decreased relative to the untreated controls during from the second week of treatment thorugh to the end of the study.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Statistically significant differences in mean food consumption (incrases and decreases) were occassionally observed for males mice in the top tow dose groups, however these were considered by the authors to spurious staistical findings reflecting normal bilogical variation and not a response to treatment with the substance. No treatment-related effects were observed for females.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Organ weight findings were statistically significantly different from both control groups in the top dose group for both sexes. This was considered by the study authors to be associated with the decreased overall body weight and not a direct effect of the treatment.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No treatment-related changes, which could be considered adverse, were observed in male and female mice following dosing with the substance, when administered in powdered rodent diet for at least 78 weeks at the approximate concentrations of 100, 500 or 1000 ppm (corresponding to mean intake dose levels of 15, 76.3 and 155.5 mg/kg bw/day for the males and 18.6, 93.1 and 193.1 mg/kg bw/day for the females). The NOEL identified in this study was 500 ppm based on reduced weight and reduced weight gain in both sexes.
- Executive summary:
Male and female mice were administered the substance in powdered rodent diet for at least 78 weeks at the approximate concentrations of 100, 500 or 1000 ppm (corresponding to mean intake dose levels of 15, 76.3 and 155.5 mg/kg bw/day for the males and 18.6, 93.1 and 193.1 mg/kg bw/day for the females). No treatment-related mortality occurred and no treatment-related clinical signs were observed during the study. There was no effect observed in the haematology parameters monitored. There were treatment-related changes observed in body weight and body weight gain, however this was not considered to be of toxicological relevance and thus not considered by the study authors to be adverse. Organ weight findings were statistically significantly different from both control groups in the top dose group for both sexes. This was considered by the study authors to be associated with the decreased overall body weight and not a direct effect of the treatment. No treatment-related findings were reported at post mortem macroscopic observations and histopathological examination. The NOEL identified in this study was 500 ppm based on reduced weight and reduced weight gain in both sexes.
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