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EC number: 208-534-8 | CAS number: 532-32-1
- 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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

Carcinogenicity
Administrative data
Description of key information
1) A carcinogenicity study (Sodemoto, 1979) is available which is key study. This study showed that the test substance was not carcinogenic.
2) A tumorigenicity study (Toth, 1984) is available which is supporting study. It is concluded that the test substance was not carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study summary. Study predates approved guidelines, minimal data provided on study design and results, no GLP.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study predates approved guidelines.
The carcinogenicity of the test substance was examined in Fischer 344 rats. The test substance was administered in the diet for 18 to 24 months at two dose levels. - GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Provided by Japan CLEA Co. Ltd.
- Age at study initiation: 4-5 weeks old
- Weight at study initiation: 110-150 g
- Fasting period before study:
- Housing: Five in each cage
- Diet (e.g. ad libitum): CE-2 pellets
- Water (e.g. ad libitum): tap water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23℃
- Humidity (%): 55%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 18-24 months
- Frequency of treatment:
- Daily
- Post exposure period:
- Immediately
- Remarks:
- Doses / Concentrations:
1 or 2%
Basis:
nominal in diet - No. of animals per sex per dose:
- Test group: 50 males and 52 females per dose
Control group: 25 males and 43 females - Control animals:
- yes, plain diet
- Details on study design:
- Both male and female rats were divided into three groups and maintained on the diet containing 2 or 1% of the test substance or basal diet for 18 to 24 months.
The animals were maintained on a free choice diet, but amount of diet was adequately controlled to avoid excess. Tap water was freely offered to all animals. The rats were weighed weekly, and food intake was measured daily. - Observations and examinations performed and frequency:
- Mortality, growth, food intake, behavior and general status were observed in the experimental period.
- Sacrifice and pathology:
- In the middle of the experimental period, several animals from each groups selected at random were sacrificed for morphologic examination. All surviving animals were killed between 18 to 25 months. For morphologic examination, autopsy was carried out in all animals and paraffin sections of various organs were prepared and stained (hematoxylin and eosin).
- Other examinations:
- None stated
- Statistics:
- T-test
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical signs and mortality:
During the first 16 months of the experimental period, the average mortality rate of all animals was 14.5%. Except for myeloproliferative disorder developed in one female control rat, all the dead animals showed pneumonia with abscess. Around 100 rats including those of the control groups died after 16 months of hemorrhagic pneumonia with edema which was probably induced by mixed infection of sialodacryoadenitis and mycoplasma. However, no differences in mortality rates between treated and control groups were observed throughout the experimental course.
Body weight gain and food intake:
Nor were there any significant differences in growth and food intake between groups of rats.
Histopathology:
Most developed tumours were benign, such as interstitial cell tumour of the testes and endometrial polyp of the uterus. However, a small number of malignant neoplasms including leukemia was also observed. Differences in numbers of tumor-bearing animals and time-to-tumor development between control and treated gorups were not significant (t-test). No specific toxic effect induced by the test substance was observed. - Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No findings of toxicological significance at 1000 mg/kg bw/day.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- From the results of this study, it may be concluded that the test substance was not carcinogenic for male and female Fischer 344 rats after 18 to 24-month dietary exposure.
The reliability of this study should be defined as 2 (reliable with restrictions) due to minimal data on study design and results and no GLP. - Executive summary:
The carcinogenicity of the test substance was examined in Fischer 344 rats. The test substance was administered in the diet for 18 to 24 months at two dose levels.
No adverse clinical signs directly attributable to the compound were observed in treated animals. Differences in the average body weight, and mortality rates between treated and control groups were negligible. The results of the statistical test for dose-related trends were significant (p<0.05). Although a variety of tumors occurred among test and control rats of each sex, tumors appearing in treated rats were similar in type and number to those in controls. It was concluded that no evidence of carcinogenicity in rats from the test substance was demonstrated.
The reliability of this study should be defined as 2 (reliable with restrictions) due to minimal data on study design and results and no GLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- 2 (reliable with restrictions)
Justification for classification or non-classification
The test substance was not carcinogenic to rats and mice at doses of 1000 mg/kg bw and above.
Therefore in accordance with Regulation (EC) No. 1272/2008 Tables 3.6.1 the substance is not classified for carcinogenesis.
Additional information
1) A carcinogenicity study was conducted using rats exposed via diet (Sodemoto, 1979). Key study.
This study showed that the test substance was not carcinogenic, and resulted a NOAEL value of >1000 mg/kg bw/day (2% in food).
2) A tumorigenicity study was conducted using mice exposed via drinking water (Toth, 1984). Supporting study.
It is concluded that the test substance was not carcinogenic, and resulted a NOAEL value of >4000 mg/kg bw/day. This study should be a supporting study due to the test substance was administered as a 2% solution in drinking water.
Justification for selection of carcinogenicity via oral route endpoint:
This study was conducted according to a reliable method using Fischer 344 rats. The test substance was administered in the diet for 18 to 24 months at two dose levels.
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