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EC number: 815-031-2 | CAS number: 1411949-02-4
- 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
Oral:
In an acute oral toxicity study according to OECD Guideline 423 in Sprague-Dawley rats, an LD50 of 2,500 mg/kg bw was determined.
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:
- from 2017-09-05 to 2017-11-07
- 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
- Test type:
- acute toxic class method
- Limit test:
- no
- 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
- Age at study initiation: 8 − 9 weeks
- Weight at study initiation: 180.7 − 201.4 g
- Fasting period before study: Animals were fasted overnight, approximately 16 hours prior to dosing.
- Housing: One animal/cage in Stainless wire mesh cage
- Diet: Pelleted rodent chow (Teklad Certified Irradiated Global 18 % Protein Rodent Diet 2918C); Envigo RMS, Inc., U.S.A., ad libitum
- Water: Public tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 − 23.0
- Humidity (%): 46.0 − 58.3
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60 and 400 mg/mL
- Amount of vehicle: 5 mL/kg bw
- Justification for choice of vehicle: As a result of the vehicle review, the test substance was not dissolved in water for injection, and it was not uniformly suspended. Therefore, corn oil was selected as the vehicle since the test substance was soluble in it.
- Lot no: MKCC0462
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
DOSAGE PREPARATION: The required amount of the test substance was weighed using an electronic balance (CP423S, Sartorius, Germany) and placed in a 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 concentrations (60 and 400 mg/mL). All preparations were conducted just prior to use.
CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 300 mg/kg because there were no available toxicity information on the test substance. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 x 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs (type, severity, time of onset and recovery) 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 (Day 1−Day 14). The body weight was recorded 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
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Statistical analysis was not performed. Mean scores and values were determined.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths of animals at 300 mg/kg bw throughout the study. Two animals at 2000 mg/kg bw were found dead on Day 1 and 4. The death was considered to be a test substance-related effect
- Clinical signs:
- At 300 mg/kg bw, abnormal gait was observed in all animals at 0.5, 1, 2, 4, and 6 hours after dosing, and lacrimation was observed in 4 − 5 animals at 1 and 2 hours after dosing, and they disappeared on Day 1.
At 2000 mg/kg bw, abnormal gait was observed in all animals at 0.5, 1, 2, 4, and 6 hours after dosing, and salivation and/or lacrimation were observed in 1 − 6 animals at 0.5, 1, 2, and 4 hours after dosing. Then, one animal was found dead in a state of prone position on Day 1. A decrease of fecal volume, chromaturia (red), decrease in locomotor activity and/or lacrimation were observed in the other animal on Days 1 − 3, and the animal was found dead in a state of prone position on Day 4. In other surviving animals, no stool, decrease of fecal volume, abnormal gait and/or decrease in locomotor activity were observed in 1 − 4 animals on Days 1 − 3 after dosing, and they disappeared on Day 4.
These clinical signs at 300 and 2000 mg/kg bw were considered to be test substance-related effects. - Body weight:
- At 300 mg/kg bw, a tendency for suppression of body weight gain was observed three animals on Day 1.
In surviving animals at 2000 mg/kg bw, a tendency for suppression of body weight gain was observed in two animals on Day 1 and a decrease in body weight was observed in two animals each on Day 1 and Day 3. Then, normal body weight gain was observed in these animals on Day 7. In one of dead animals at 2000 mg/kg bw, a decrease in body weight was observed on Days 1 and 3.
These body weights changes at 300 and 2000 mg/kg bw were considered to be test substance-related effects. - Gross pathology:
- No grossly visible findings were observed in any animal at 300 mg/kg bw.
Enlarged adrenal, small spleen, small thymus and multiple black spots in the glandular stomach were noted in one dead animal at 2000 mg/kg bw, and these changes were considered to be stress-related changes. - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- In an acute oral toxicity study according to OECD Guideline 423 in Sprague-Dawley rats, the test item was classified as Category 5 according to the GHS classification and the median lethal dose derived was LD50cut off = 2,500 mg/kg bw
- Executive summary:
In an acute oral toxicity study according to OECD Guideline 423 the potential toxicity of the test item following a single oral dose administration (gavage) to female Sprague-Dawley rats was assessed. All animals were monitored for clinical signs and body weight changes during the 14-day observation period after administration. They were subjected to a gross necropsy at the end of the observation period. A dose of 300 mg/kg bw was sequentially administered to groups of 3 femals. There were no deaths of animals at 300 mg/kg. Abnormal gait and/or lacrimation were observed in animals at 300 mg/kg on the day of dosing, and the observations disappeared on Day 1. A tendency for suppression of body weight gain was observed in three animals on Day 1. No test substance-related effects were observed in necropsy findings in any animal at 300 mg/kg. Following the guideline, a dose of 2000 mg/kg bw was sequentially administered to groups of 3 femals. Two animals were found dead at 2000 mg/kg bw on Days 1 and 4. Abnormal gait, salivation and/or lacrimation were observed in animals on the day of dosing. Then, one animal was found dead on Day 1. A decrease of fecal volume, chromaturia (red), decrease in locomotor activity and/or lacrimation were observed in the other animal on Days 1 − 3, and the animal was found dead on Day 4. In other surviving animals, no stool, decrease of fecal volume, abnormal gait and/or decrease in locomotor activity were observed in animals on Days 1 − 3 after dosing, and the observations disappeared on Day 4. In the surviving animals at 2000 mg/kg bw, a tendency for suppression of body weight gain was observed in two animals on Day 1 and a decrease in body weight was observed in two animals each on Day 1 and Day 3. Then, normal body weight gain was observed in these animals on Day 7. In one of dead animals at 2000 mg/kg bw, a decrease in body weight was observed on Days 1 and 3. Macroscopic examination revealed enlarged adrenal, small spleen, small thymus and multiple black spots in the glandular stomach in one dead animal at 2000 mg/kg bw.
Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test item, was classified as Category 5 according to the GHS classification and the median lethal dose derived was LD50 cut off = 2,500 mg/kg bw.
Reference
Table 1: Summary of Mortality
Step /Dose (mg/kg bw) |
No of Animals |
Days after Dosing |
Mortality |
||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
Step 1 300 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Step 2 300 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Step 1 2000 |
3 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/3 |
Step 2 2000 |
3 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Study accoridng to OECD Guideline 423 and GLP.
Additional information
Oral:
In an acute oral toxicity study according to OECD Guideline 423 the potential toxicity of the test item following a single oral dose administration (gavage) to female Sprague-Dawley rats was assessed. All animals were monitored for clinical signs and body weight changes during the 14-day observation period after administration. They were subjected to a gross necropsy at the end of the observation period. A dose of 300 mg/kg bw was sequentially administered to groups of 3 femals. There were no deaths of animals at 300 mg/kg. Abnormal gait and/or lacrimation were observed in animals at 300 mg/kg on the day of dosing, and the observations disappeared on Day 1. A tendency for suppression of body weight gain was observed in three animals on Day 1. No test substance-related effects were observed in necropsy findings in any animal at 300 mg/kg. Following the guideline, a dose of 2000 mg/kg bw was sequentially administered to groups of 3 femals. Two animals were found dead at 2000 mg/kg bw on Days 1 and 4. Abnormal gait, salivation and/or lacrimation were observed in animals on the day of dosing. Then, one animal was found dead on Day 1. A decrease of fecal volume, chromaturia (red), decrease in locomotor activity and/or lacrimation were observed in the other animal on Days 1 − 3, and the animal was found dead on Day 4. In other surviving animals, no stool, decrease of fecal volume, abnormal gait and/or decrease in locomotor activity were observed in animals on Days 1 − 3 after dosing, and the observations disappeared on Day 4. In the surviving animals at 2000 mg/kg bw, a tendency for suppression of body weight gain was observed in two animals on Day 1 and a decrease in body weight was observed in two animals each on Day 1 and Day 3. Then, normal body weight gain was observed in these animals on Day 7. In one of dead animals at 2000 mg/kg bw, a decrease in body weight was observed on Days 1 and 3. Macroscopic examination revealed enlarged adrenal, small spleen, small thymus and multiple black spots in the glandular stomach in one dead animal at 2000 mg/kg bw.
Based on the result of the acute oral toxicity study in Sprague-Dawley rats, an LD50 of 2500 mg/kg bw of the test item was determined.
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.
Based on this data, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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