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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Storage condition of test material: At room temperature
Constituent 1
Test animals
- 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
Administration / exposure
- 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.
Results and discussion
Effect levels
- 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
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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