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EC number: 949-569-5 | CAS number: -
- 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
Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the median lethal dose derived for the test substance was LD50 ≥ 5000 mg/kg bw.
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:
- 2019-03-26 to 2019-06-12
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: “Regulation on Test Methods for Chemical Substances” Notification No. 2018-12, National Institute of Environmental Research, Republic of Korea (Apr. 9, 2018)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- (Crl:CD(SD)), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 weeks old
- Weight at study initiation: 189.7 - 197.0 g
- Fasting period before study: ca. 16 hours prior to dosing
- Housing: Stainless wire mesh cage, 260W×350D×210H (mm), One animal/cage (during the study)
- Diet (ad libitum): Pelleted rodent chow (Teklad Certified Irradiated Global 18 % Protein Rodent Diet 2918C) provided 4 hours post dosing
- Water (ad libitum): filtered and irradiated with UV light public tap water
- Acclimation period: 4 days quarantine and 3 days acclimation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2 - 22.3
- Humidity (%): 46.4 - 55.5
- Air changes (per hr): 10 − 15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle, light intensity: 150 − 300 Lux - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Lot no.: MKCG3257
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
DOSAGE PREPARATION: The required amount of the test substance was weighed on an electronic balance and placed in a glass bottle. A small amount of vehicle, corn oil, was added and mixed using a vortex mixer until dissolved. The vehicle was gradually added to yield the desired concentration. All preparations were conducted just prior to use.
CLASS METHOD
- Rationale for the selection of the starting dose: IDue to the low expected toxicity of the test substance, 2,000 mg/kg was selected as the starting dose for this study - Doses:
- Groups 1 and 2 (Steps 1 and 2): 2,000 mg/kg of the test substance
Steps 1−2: A dose of 2,000 mg/kg was administered and no mortality was observed (Step 1). A second dose of 2,000 mg/kg was administered. Again, no mortality was observed (Step 2). - No. of animals per sex per dose:
- 3 females/group, two steps
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days; weighing - prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy (Day 14)
- Necropsy of survivors performed: yes - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths of animals at 2000 mg/kg throughout the study.
- Clinical signs:
- other: Abnormal gait was observed in 2 animals at 2000 mg/kg at 6 hours after dosing. Mucous stool was observed in 4 animals on Day 1, and they disappeared on Day 2.
- Gross pathology:
- No grossly visible findings were observed in any animal at 2000 mg/kg.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the median lethal dose derived for the test substance was LD50 ≥ 5000 mg/kg bw.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Sprague-Dawley (Crl:CD(SD)) female rats. The test was performed according to OECD 423 "Acute Oral Toxicity - Acute Toxic Class Method", EU Method B1 tris and “Regulation on Test Methods for Chemical Substances” Notification No. 2018-12, National Institute of Environmental Research, Republic of Korea (Apr. 9, 2018). 2000 mg/kg bw was selected as the starting dose. A group of three fasted females was treated with the starting dose. This was followed by another group of three fasted females at the same dose level. The test item was administered orally via gastric intubation, diluted in corn oil. The animals were observed 30 min, 1, 2, 4 and 6 hours after dosing and then once daily for fourteen days. Bodyweights were recorded on the day of dosing and on Days 1, 3, 7 and 14. At the end of the observation period all animals were anesthetized with CO2 and exsanguinated from the abdominal aorta and subjected to complete gross necropsy. There were no deaths during the study. Abnormal gait was observed in 2 animals at 2,000 mg/kg at 6 hours after dosing. Mucous stool was observed in 4 animals on Day 1, and they disappeared on Day 2. No other adverse clinical signs were noted. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral LD50 of the test item in the Sprague-Dawley rat, was estimated as being greater than 5000 mg/kg bw as no mortalities were noted in animals treated with 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 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
OECD 423
A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Sprague-Dawley (Crl:CD(SD)) female rats. The test was performed according to OECD 423 "Acute Oral Toxicity - Acute Toxic Class Method", EU Method B1 tris and “Regulation on Test Methods for Chemical Substances” Notification No. 2018-12, National Institute of Environmental Research, Republic of Korea (Apr. 9, 2018). 2000 mg/kg bw was selected as the starting dose. A group of three fasted females was treated with the starting dose. This was followed by another group of three fasted females at the same dose level. The test item was administered orally via gastric intubation, diluted in corn oil. The animals were observed 30 min, 1, 2, 4 and 6 hours after dosing and then once daily for fourteen days. Bodyweights were recorded on the day of dosing and on Days 1, 3, 7 and 14. At the end of the observation period all animals were anesthetized with CO2 and exsanguinated from the abdominal aorta and subjected to complete gross necropsy. There were no deaths during the study. Abnormal gait was observed in 2 animals at 2,000 mg/kg at 6 hours after dosing. Mucous stool was observed in 4 animals on Day 1, and they disappeared on Day 2. No other adverse clinical signs were noted. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral LD50 of the test item in the Sprague-Dawley rat, was estimated as being greater than 5000 mg/kg bw as no mortalities were noted in animals treated with 2000 mg/kg bw.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The LD50 was greater than 5000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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