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EC number: 940-820-4 | 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
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Endpoint summary
Administrative data
Description of key information
The test substance was found to have an LD50 of 300< LD50 ≤2000 mg/kg in the acute oral toxicity study. The substance is classified in Category 4 for Acute Oral Toxicity, in accordance with EU CLP criteria. The LD50 found in the acute dermal toxicity study was >2500 mg/kg bw, as such EMI-DBS is not classified as an acute dermal toxin in accordance with EU CLP criteria.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 423.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Specific Pathogen Free (SPF) Sprague Dawley (SD) rats
Supplier and producer: ORIENT BIO INC. (Korea)
Reasons for choice of the species: SD rats have been applied widely in general toxicity tests as a suitable experimental animal for toxicity testing. In addition, sufficient raw data has been accumulated and is available for interpretation and evaluation of study results.
Date of acquisition: 1st acquisition: 20 October 2011, 2nd acquisition: 3 November 2011.
Number of animals received: 7 female rats for each acquisition
Age of animals received: 7 weeks
Body weight on arrival: 1st: 173.12-180.57 g, 2nd: 169.61-194.22 g.
Quarantine and acclimation: Animals were acclimated for 7-14 days. Only animals with the best appearance were selected for the test after observation during the acclimation period, animals were accepted based on the certification provided by the supplier.
Age at the intiation of the administration: 8-9 weeks
Body weight at the administration: 1st step: 300 mg/kg: 189.37-195.99, 2nd step: 300 mg/kg: 198.61-212.87 g, 3rd step: 2000 mg/kg: 197.44-206.76 kg.
Number of animals administered test substance: Each step used 3 female rats. Total 9 female rats were administered the test substance.
Grouping: Animals were weighed one day before the test substance administration, and grouped to ensure a distribution of graded body weight.
Identification of animals: Individual animals were identified by tail marking with an oily-ink felt pen. Individual cages were distinguished by the individual card labelling. The record sheets provided at the entrance of the SPF amimal room contained the study number, the study title, the duration of the SPFroom use, the name of the study director and the names of the study personnel.
Disposal of remaining animals: Remaining animals were euthanized.
Animal care room: Room 1 in the SPF animal facility area.
Temperature and humidity during test work: 22.7 ± 0.8°C and 53.0 ± 5.1 %RH.
Ventilation frequency: 10-15 air changes/hour
Lighting cycle: 12 hours duration (lighting on at 8 am and off at 8 pm)
Lighting intensity: 281 Lux
Ambient noise level: 52.8 dB
Ammonia concentration: less than 5 ppm
Housing: All animals were housed in a wire mesh cage (250 W x 350 L x 180 H mm) during quarantine, acclimation, administration and observation period.
Animal number per cage: During the experiment, not more than 3 animals were housed in a cage.
Change of cages: At grouping, test animal cages were changed.
Feed: (1) Tyep: Radiation sterilized, solid laboratory animal feed (2): Supplier: DooYeol Biotech Co., Ltd (3) Producer: Harlan Laboratories, Inc., USA (4) Supply Method: ad libitum (5) Analysis: Feed analysis data was provided from the supplier
Water: (1) Type: Incheon, Korea municipal tap water purified by reverse osmosis filtering system (2) Supplying method: ad libitum using water bottles (3) Analysis: Performed by national certificated inspection organisation. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Vehicle Information
Name: Corn oil
Lot No: MKBF2096V
CAS No: 8001-30-7
Received Date: 23 June 2011
Received Quantity: 500 ml
Appearance: Pale yellow liquid
Storage Condition: At room temperature
Manufacturer: SIGMA
Justification for choice: According to the solubility test, prior to study initiation, corn oil was chosen because the test substance solution suspended evenly in corn oil by heating (approximately at 40°C) and shaking (sonication) for 10 minutes.
Preparation of the test substance
The test substance was measured on the administration day, prepared and suspended in corn oil. For the first and second step, 0.30 g of the test substance was suspended in corn oil by heating (approximately at 40°C) and shaking (sonication) for 10 minutes to make a total volume of 10 ml at the dose level of 300 mg/kg. For the third step, 2 g of the test substance was suspended in corn oil by heating (approximately at 40°C) and shaking (sonication) for 10 minutes to make a total volume of 10 ml at the dose level of 2000 mg/kg. To clarify the homogeneity of test samples, a homogeneity test was performed with HPLC (MAI-072-01). In the test result, it was found that the standard curve had a linearity at 25 µg/ml - 100 µg/ml concentrations and these data emerged reproducible. The coefficient of variation for the EMI-DBS is 1.91%. According to homogeneity analysis result, it was confirmed that the test samples had homogeneity. - Doses:
- The dose level was determined in accordance with 'Acute Toxic Class Method' the Test Guidelines of the National Institute of Environment Research (NIER) [Notice No. 2010-29, (revised 16 August 2010)] and the OECD Guideline for Testing of Chemicals No. 423 'Acute Toxic Class Method' (Adopted 17 December 2001). The first step dose was 300 mg/kg due to an absence of toxicity data of the test substance. The second step dose was 300 mg/kg and the third step dose was 2000 mg/kg.
- No. of animals per sex per dose:
- 3 female rats per dose.
- Control animals:
- no
- Details on study design:
- Route of administration: Oral
Reason for choice of the route of administration: Common method to evaluate acute oral toxicity
Method of administration: Rats were fasted one night before the administration day to empty their stomach. An intubation cannula was used for the oral administration. All fasted test animals were fed approximatelt at three to four hours after test substance administration.
Calculation of dosing volume: Individual dosage was adjusted based on fasted body weight measured right before the administration. Dosing volume was 10 ml/kg.
Frequency and period of administration: Once
Observations
(1) Clinical signs and mortalities: General clinical signs or mortalities of all treated animals were observed continuously during the first half-hour and one hour from the administration time. After that, the animals were observed once hourly up to the first six hours on the administration day. From the next day, each animal was observed once every day up to 14 days after the administration.
(2) Body weight: Individual animals were weighed before the administration and at 1, 4, 7 and 14 days after the administration.
(3) Necropsy and gross findings examination: On day 14 after the administration, all surviving animals were anesthetized with CO2 gas, and terminated by exsanguination from the aorta. Complete post-mortem examinations were performed on all vital organs. - Statistics:
- Data analysis
Each body weight change was evaluated during the observation period. The mean value and the standard deviation of each animal group were applied to resulting data. No additional statistical assessment was performed in data analysis. The LD50 value was classified according to the Notice No. 2010-29 (revised 16 August 2010) of the National Institute of Environmental Research. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No 95% CL were provided
- Mortality:
- No mortalities were observed during the observation period in the first step (300 mg/kg) and the second step (300 mg/kg). There were two dead animals (animal number 7 and 8) 1 day after administration in the third step (2000 mg/kg).
- Clinical signs:
- other: No unusual clinical signs were observed during the observation period in the first step (300 mg/kg) and the second step (300 mg/kg). In the third step (2000 mg/kg) clinical signs were observed. These were mucous stool and inanimation from 2 to 6 hours aft
- Gross pathology:
- No abnormal gross findings were observed during necropsy on all animals in the first and second steps. In the third step, no gross abnormalities were found in necropsy of the surviving animals or the dead animals.
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the of the acute oral toxicity study of EMI-DBS to Sprague-Dawley rats, the lethal dose 50 (LD50) is considered to be GHS classification 4 (300< LD50 ≤2000 mg/kg) in this study.
- Executive summary:
The acute oral toxicity of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 423. The test substance was orally administered to female Sprague-Dawley rats. The first and second step doses were 300 mg/kg bw/day, the third step dose was 2000 mg/kg bw/day. The first step dose was chosen due to an absence of toxicity data on the test substance. Mortalities, clinical signs and body weight changes were monitored during the 14 -day observation period. Necropsy and gross findings were performed for all animals. There were no dead animals or unusal clinical signs or unusual observations at necropsy in the animals in the first and second steps (300 mg/kg). There were two dead animals 1 day after administration of the test substance in the third step (2000 mg/kg). Mucous stool and inanimation on the administration day were recorded as clinical signs in the third step. No abnormal gross findings were observed during necropsy. Based on the results of the study, EMI-DBS was found to have an LD50 of 300< LD50 ≤2000 mg/kg. The substance is classified in Category 4 for Acute Oral Toxicity, in accordance with EU CLP criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- 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
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Remarks:
- This study was available at the time of registration and is submitted as part of an obligation to submit all relevant information on the substance. The study was not commisioned for REACH registration purposes.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by a GLP accredited laboratory using a test method eqiuivalent to OECD Testing Guideline 402.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Acdemy of Militray Medical Sciences
- Weight at study initiation: 200 g
- Fasting period before study: 3 days
- Housing: SPF
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20~25
- Humidity (%): 40%~70% - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- % coverage: 40%
- Type of wrap if used: gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2500mg/kg bw
- Constant volume or concentration used: no
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- 2500 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Duration of observation period following administration: 14 days
Frequency of observations and weighing: 0 d; 7 d; 14 d
Necropsy of survivors performed: no
Other examinations performed: clinical signs, body weight,organ weights, histopathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Remarks on result:
- other: No 95% CL information was provided
- Mortality:
- No deaths were observed.
- Clinical signs:
- other: No clinical sign were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no deaths and no clinical signs were observed during the observation period. The LD50 found in the study was >2500 mg/kg bw, as such EMI-DBS is not classified as an acute dermal toxin in accordance with EU CLP criteria.
- Executive summary:
The acute dermal toxicity of the test substance was determined using a method equivalent to the OECD Guideline for Testing of Chemicals 402. A dose of 2500 mg/kg bw was applied occlusively by gauze to the skin of male and female Wistar rats. The rats were exposed to the test substance for 24 hours. There were no deaths and no clinical signs were observed during the observation period. The LD50 found in the study was >2500 mg/kg bw, as such EMI-DBS is not classified as an acute dermal toxin in accordance with EU CLP criteria.
Reference
Summary of results
Animal |
Dose Level |
Animal |
Weight (g, Average±SD) |
Death |
Mortality |
LD50 |
||
Sex |
(mg/kg bw) |
Number |
0 day |
7 days |
14 days |
Number |
% |
(g/kg bw) |
Male |
2500 |
5 |
211.4 ± 5.7 |
253.2 ± 9.7 |
288.8 ± 9.8 |
0 |
0 |
>2500 |
Female |
2500 |
5 |
213.2 ± 3.2 |
226.2 ± 4.4 |
237.2 ± 3.3 |
0 |
0 |
>2500 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
A study was conducted on the registered substance to determine the acute oral toxicity of the substance. The acute oral toxicity of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 423. The test substance was orally administered to female Sprague-Dawley rats. The first and second step doses were 300 mg/kg bw/day, the third step dose was 2000 mg/kg bw/day. The first step dose was chosen due to an absence of toxicity data on the test substance. Mortalities, clinical signs and body weight changes were monitored during the 14 -day observation period. Necropsy and gross findings were performed for all animals. There were no dead animals or unusal clinical signs or unusual observations at necropsy in the animals in the first and second steps (300 mg/kg). There were two dead animals 1 day after administration of the test substance in the third step (2000 mg/kg). Mucous stool and inanimation on the administration day were recorded as clinical signs in the third step. No abnormal gross findings were observed during necropsy. Based on the results of the study, EMI-DBS was found to have an LD50 of 300< LD50 ≤2000 mg/kg. The substance is classified in Category 4 for Acute Oral Toxicity, in accordance with EU CLP criteria.
A study was conducted on the registered substance to determine the acute dermal toxicity of the substance. The acute dermal toxicity of the test substance was determined using a method equivalent to the OECD Guideline for Testing of Chemicals 402. A dose of 2500 mg/kg bw was applied occlusively by gauze to the skin of male and female Wistar rats. The rats were exposed to the test substance for 24 hours. There were no deaths and no clinical signs were observed during the observation period. The LD50 found in the study was >2500 mg/kg bw, as such EMI-DBS is not classified as an acute dermal toxin in accordance with EU CLP criteria.
Justification for selection of acute toxicity – oral endpoint
This key study was performed in a GLP accredited laboratory using OECD Testing Guideline 423.
Justification for selection of acute toxicity – dermal endpoint
This key study was performed in a GLP accredited laboratory using a method equivalent to OECD Testing Guideline 402.
Justification for classification or non-classification
The test substance was found to have an LD50 of 300< LD50 ≤2000 mg/kg in the acute oral toxicity study. The substance is classified in Category 4 for Acute Oral Toxicity, in accordance with EU CLP criteria. The LD50 found in the acute dermal toxicity study was >2500 mg/kg bw, as such EMI-DBS is not classified as an acute dermal toxin in accordance with EU CLP criteria.
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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