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Diss Factsheets
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EC number: 619-290-0 | CAS number: 97780-06-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance as a suspension in corn oil was administered by intragastric intubation to 6 male Crl:CD®(SD)BR rats. Rats were dosed at 2200 mg/kg/day for 10 days (weekends excluded) over a 2 week period. Six control rats were simultaneously dosed with corn oil. At the end of the dosing period, 3 rats per group were killed for pathologic examination. The remaining rats were observed for 14 days after dosing, and were given similar pathologic examinations.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 97780-06-8
- Test material form:
- solid
- Details on test material:
- Purity: 96.4%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York
- Age at study initiation: Young adult (No more details are available)
- Weight at study initiation: Mean of 6 rats was 239.7 g
- Fasting period before study: No data
- Housing: housed singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow® #5002
- Water (e.g. ad libitum): Tap water
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hour/1-Z-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The test substance as a suspension in corn oil was administered by intragastric intubation to 6 male Crl:CD®(SD)BR rats.
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- 5 days a week
Doses / concentrations
- Dose / conc.:
- 2 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily, weekends excluded
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily, weekends excluded
BODY WEIGHT: Yes
- Time schedule for examinations: Daily, weekends excluded
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: Rats were killed by chloroform anesthesia and exsanguination. Organs and tissues examined were the liver, kidneys, urinary bladder, lungs, heart, spleen, thymus, pancreas, adrenal glands, thyroid gland, trachea, esophagus, brain, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, mesenteric lymph node, testes, epididymides, sternum, bone marrow, eyes and gross lesions.
HISTOPATHOLOGY: No - Statistics:
- Data were statistically analyzed by a one-way analysis of variance. Test rats were compared with controls by least significant difference and Dunnett's tests. Significance was judged at the 0.05 probability level.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Apparent compound related lesions occurred in the proximal tubules of the kidneys in 2 of 3 test animals killed on the last day of exposure and in 1 of 3 test animals killed after a recovery period of 14 days. Large numbers of epithelial cells contained intracytoplasmic protein droplets. This lesion was moderately severe in one animal killed on the last day of exposure and in one 14-day-recovery animal and mildly severe in one animal killed on the last day of exposure. Occasional scattered necrotic epithelial cells were noted in kidneys of all affected animals. Other lesions seen in these animals were considered incidental and not compound related.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- LOEL
- Effect level:
- 2 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- gross pathology
- Remarks on result:
- other: Kidney effects
Applicant's summary and conclusion
- Conclusions:
- Gross pathological changes were evident in the kidneys of 2 of 3 test animals killed on the last day of exposure and in 1 of 3 test animals killed after a 14-day recovery period.
- Executive summary:
The test substance as a suspension in corn oil was administered by intragastric intubation to 6 male Crl:CD®(SD)BR rats. Rats were dosed at 2200 mg/kg/day for 10 days (weekends excluded) over a 2 week period. Six control rats were simultaneously dosed with corn oil. At the end of the dosing period, 3 rats per group were killed for pathologic examination. The remaining rats were observed for 14 days after dosing, and were given similar pathologic examinations.
Mean body weights for test and control rats were similar throughout the dosing and recovery periods. There were no clinical signs of toxicity observed in the test animals. There were no significant differences in organ weights or organ to body weight ratios when test animals were compared to controls. The test substance was mildly toxic to the epithelial cells of the proximal·tubules of the kidney. Recovery was not complete in animals killed after a 14-day recovery period.
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