Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2017-11-21 to 2018-01-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted: 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Lot No.: C170806
Purity: 100 %
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Orient Bio Co., Ltd.
- Age and weight at study initiation:
9 weeks old , 189.6 g - 191 .4 g (1st step)
10 weeks old , 192.7 g - 204.6 g (2nd step)
9 weeks old, 204.5 g - 210.7 g (3rd step)
10 weeks old , 209.0 g - 229.5 g (4th step)
- Fasting period before study: over-night (18 hours)
- Housing: Stainless steel wire cage, (310W x 5000 x 200H) mm, Less than 3 animals per cage
- Diet: Rodent Oiet 20 5053 [Labdiet, USA], ad libitum
- Water: R/O water, ad Iibitum
- Acclimation period: at least 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 .5 - 23.2
- Humidity (%): 48.7 - 62.8
- Air changes (per hr): 10-20 times/h
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methyl cellulose : Sterile distilled water = 1g : 100 mL
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL (1st, 2nd step) , 200 mg/mL (3rd, 4th step)
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: This vehicle has been used widely in toxicity study. Before the study initiation date, this vehicle was chosen as appropriate vehicle of test substance preparation through the vehicle test.
- Lot/batch no. (if required): SLBR1658V for Methyl cellulose; A2R8B21, S1R9B21 for Sterile distilled water
DOSAGE PREPARATION:
Test substance was formulated with vehicle at 30 mg/mL (1st, 2nd step), 200 mg/mL (3rd, 4th step) concentration. The mixture of the test substance was homogenized by shaking. Each step of the preparation was conducted just prior to use.
CLASS METHOD
- Rationale for the selection of the starting dose: Based on LD50 of Material safety data sheet were 1710 and 2330 mg/kg for female and male rats separately. The starting dose level was 2000 mg/kg B.W in study plan. However, the document was wrongly written in preparation of test substance and dose level was changed to 300 mg/kg B.W. But this deviation is considered to be no effect on result of study. - Doses:
- 1st and 2nd step: 300 mg/kg B.W
3rd and 4th step: 2000 mg/kg B.W - No. of animals per sex per dose:
- 3 females for each
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs were carefully observed for 0.5, 1, 2, 3 and 4 hours after treatment and then once each day for 14 days.
Body weight were measured at animal receipt day, animal allocation day, just before treatment and on day 7 and 14 after the administration, found death animal.
- Necropsy of survivors performed: yes, At the end of observation period and death of animal, external observations were conducted and all survived animals were sacrificed by blood letting under anesthesia. Then the organs were examine for gross lesions.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test substance-related dead animal was observed in 1 animal (on day 1) at 2000 mg/kg B.W. (3rd step).
- Clinical signs:
- There were no clinical signs caused by administration of the test substance.
- Body weight:
- For the results of body weight for animal except dead animal, 1 animal showed decreased body weight in 300 mg/kg B.W. (2nd step) on day 14 as compared with day 7. The other animals showed the normal increase of body weight during the study period.
- Gross pathology:
- In the necropsy finding of dead animal, hemorrhage in around mouth in external finding was observed in 1 animal at 2000 mg/kg B.W. (3rd step).
In the necropsy of surviving animals, there were no abnormal findings caused by administration of the test substance.
Applicant's summary and conclusion
- Conclusions:
- The LD50 was determined to be > 2000 mg/kg body weight.
- Executive summary:
The present study, to investigate acute oral toxicity of the test item, was conducted on female Sprague-Dawley (SD) rats. An acute dose of the test substance was administered by oral route at a dose of 300 mg/kg B.W. (1st t, 2nd step) and 2000 mg/kg B.W. (3rd, 4th step). Three animals were used for each step and there were 4 steps in total.
- The test substance-related dead animal was observed in 1 animal at 2000 mg/kg B.W. (3rd step).
-There were no clinical signs caused by administration of the test substance.
- For the results of body weight for animal except dead animal, no test substance-related effects were observed.
- In the necropsy finding of dead animal, hemorrhage in around mouth in external finding was observed in 1 animal at 2000 mg/kg B.W. (3rd step).
In the necropsy of surviving animals, there were no abnormal findings caused by administration of the test substance.
The LD50 was determined to be > 2000 mg/kg body weight.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies