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EC number: - | 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
Acute Toxicity: Oral: LD50 > 2,000 mg/kg bw; OECD 423; Jae-Bum Na., 2018
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:
- 11 May - 20 July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted to international guideline and under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- 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
- Version / remarks:
- 2018
- Deviations:
- no
- 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: ORIENTBIOINC.,RepublicofKorea
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 163.4 - 196.9 g
- Fasting period before study: yes
- Housing: Animals were individually housed in Stainless wire mesh cage, 260W×350D×210H (mm), One animal/cage (during the study).
- Diet (e.g. ad libitum): Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C, Lot no. 2918C-012918MA) placed in feeders and provided ad libitum. - Water (e.g. ad libitum): Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0−25.0°C
- Humidity (%): 30.0−70.0%
- Air changes (per hr): 10−15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
IN-LIFE DATES: 23/5/ 2018 - 12 and 15 June 2018 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Oral via gastric intubation
- Details on oral exposure:
- Individual doses were calculated based on the animals’ body weight recorded just prior to dosing at a dose volume of 10 mL/kg body weight. Animals were dosed via gastric intubation with a 3-mL disposable syringe fitted with an intubation tube. Animals were fasted overnight, approximately 16 hours prior to dosing. Drinking water was provided ad libitum. Feed was provided approximately 4 hours after dosing.
- Doses:
- 2,000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Due to the low expected toxicity of the test substance, 2,000 mg/kg was selected as the starting dose. A dose of 2,000 mg/kg was administered to three females. Based on observation of no mortality,a second dose of 2,000 mg/kg was administered to another set of 3 female.
- Statistics:
- Not required but mean scores and values were determined.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No adverse effects observed
- Mortality:
- No deaths reported
- Clinical signs:
- other: Compound-colored stool was observed in all animals at 2,000 mg/kg on Day 1 after dosing. Then, these animals returned to a normal appearance on Day 2 after dosing.
- Gross pathology:
- No grossly visible abnormalities were observed in any animal at 2,000 mg/kg.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System).
- Executive summary:
OECD 423 (2018) - In an acute oral toxicity study, a group of 7-8 week old female Wistar rats were given a single oral dose of the test item using a stepwise dose rate of 2000 mg/kg bw and observed for 14 days.
In the absence of mortality during the observation period, the oral LD50 was estimated to be > 2000 mg/kg bw.
Compound-coloured stool was observed in animals on Day 1. This change disappeared on Day 2. No test substance-related effects were observed in the body weight data or necropsy findings in any animal at 2,000 mg/kg.
In conclusion, the test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Table 2. Mean Body Weights
Step / Dose(mg/kg) |
Days after dosing |
|||||
0 |
1 |
3 |
7 |
14 |
Gain (g)0∼14 |
|
Step 1 2,000 |
174.1 |
190.6 |
200.2 |
209.8 |
235.7 |
61.6 |
Step 1 2,000 |
186.5 |
208.7 |
221.1 |
229.6 |
246.4 |
59.9 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The endpoint is concluded based on a single key study with a Klimisch rating of 1. No effects were observed up to the limit dose of 2000 mg/kg bw/day
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 (2018) - In an acute oral toxicity study, a group of 7-8 week old female Wistar rats were given a single oral dose of the test item using a stepwise dose rate of 2000 mg/kg bw and observed for 14 days.
In the absence of mortality during the observation period, the oral LD50 was estimated to be greater than 2000 mg/kg bw.
Compound-coloured stool was observed in animals on Day 1. This change disappeared on Day 2. No test substance-related effects were observed in the body weight data or necropsy findings in any animal at 2,000 mg/kg.
In conclusion, the test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Justification for classification or non-classification
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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