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EC number: 617-328-0 | CAS number: 82391-37-5
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral key study (Nakamura, 2004):
Under the conditions of this study, the test material was found to have a LD50 > 2000 mg/kg bw when it was administered orally to rats once.
Acute toxicity: inhalation and dermal
In accordance with Column 2 of REACH Annex VIII, acute toxicity need only be addressed in one route if there is only one route of human exposure that is likely. Information on the acute toxicity of the substance is provided for the oral route of exposure, since human exposure via the dermal and inhalation routes of exposure are not considered to be likely routes of human exposure. In vivo acute dermal and/or inhalation toxicity studies will not add any value and cannot be expected to provide valuable knowledge and are thus considered scientifically and ethically unjustified.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 November 2003 to 12 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- Crj:CD(SD)IGS strain
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 167 - 179 kg at start of quarantine acclimation. body weight of each animal of each group was within ± 20% of the average body weight of all animals at the time of administration.
- Fasting period before study: 18 hours 30 minutes to 19 hours 30 minutes before administration.
- Housing: Rodents were housed in stainless steel suspended-type cages (32.5 cm (D) x 19.5 cm (W) x 18 cm (H)). There was one rat per cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature: 21.7 – 22.2°C
- Humidity: 34 – 51%
- Air changes: 15 times/hour
- Photoperiod: 12 hours/day artificial lighting (06:00 – 18:00 lamp-lighting) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Concentration not provided.
- Justification for choice of vehicle: The test material readily mixed with water and is stable in water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: A specified amount of the test material was added to water for injection and suspended. A liquid at a specified concentration was prepared when it was used. Further, at the time of weighing, the test substance stock solution was regarded as 100 %, and no purity conversion was made. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Six females were treated at a dose level of 2000 mg/kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed once a day from the day following the day of completion of quarantine/acclimation to the day preceding the day of administration. 10 times a day on the day of administration. Twice a day (in the morning and afternoon) during the period from one day after administration to 13th day and once on the day of autopsy. The body weights of all animals were measured on the day before the day of administration, immediately before administration, after 1, 2, 3, 6, 10 and 13 day from administration and on the day of autopsy.
- Necropsy of survivors performed: yes, the body weight of all animals was measured 14 days after administration (17 to 18 hours after fasting), and aqueous solution (64.8 mg/mL, 5 mL/kg) of pentobarbital sodium was administered into the abdominal cavity of the animals to anesthetise and euthanise them. The external surface, internal organs and tissues were visually observed. Since there was no organ or tissue observed that was considered to have undergone a change in weight, no weight measurement was made. Liver and kidneys (right and left) were removed and fixed in 10 % neutral buffered formalin solution. - Statistics:
- No statistical verification was carried out. The body weight, the average values and standard deviations of all animals at the time of each measurement and at administration were calculated.
- Preliminary study:
- Three females (Group 1) were treated at a dose level of 2000 mg/kg bw. In the absence of mortality or toxicity at a dose level of 2000 mg/kg bw, an additional group of 3 animals (Group 2) were treated at a dose level of 2000 mg/kg bw.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mL/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality at a dose level of 2000 mL/kg bw for any of the animals.
- Clinical signs:
- other: There were no clinical signs observed during the study.
- Gross pathology:
- There was no abnormality observed in either of the groups.
- Interpretation of results:
- other: Not classified according to EU Criteria
- Conclusions:
- Under the conditions of this study, the test material was found to have a LD50 > 2000 mg/kg bw when it was administered orally to rats once.
- Executive summary:
The acute oral toxicity of the test material using rats was investigated in accordance with the standardsied guideline OECD 423, under GLP conditions using the acute toxic class method.
2000 mg/kg bw of test material was administered orally once to Crj:CD(SD) IGS rats of 3 female animals of each group (totaling 6 animals) to investigate its toxicity. During the 2-week observation period, there was no death of any of the animals of each group, and any of them showed no abnormality. None of the animals showed any abnormality in their body weight and autopsy.
Under the conditions of this study, the test material was found to have a LD50 > 2000 mg/kg bw when it was administered orally to rats once.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral key study (Nakamura, 2004):
The acute oral toxicity of the test material using rats was investigated in accordance with the standardsied guideline OECD 423, under GLP conditions using the acute toxic class method. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
2000 mg/kg bw of test material was administered orally once to Crj:CD(SD) IGS rats of 3 female animals of each group (totaling 6 animals) to investigate its toxicity. During the 2-week observation period, there was no death of any of the animals of each group, and any of them showed no abnormality. None of the animals showed any abnormality in their body weight and autopsy.
Under the conditions of this study, the test material was found to have a LD50 > 2000 mg/kg bw when it was administered orally to rats once.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity.
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