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EC number: 220-389-2 | CAS number: 2749-59-9
- 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
The acute oral LD50 was determined to be > 300 - < 2000 mg/kg bw.
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:
- 8 Aug. 2017 to 8 Sept. 2017
- 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:
- 17 Dec. 2001
- Qualifier:
- according to guideline
- Guideline:
- other: "Regulation on Test Methods for Chemical Substances" Notification No. 2017-4, National Institute of Environmnetal Research, Republic of Korea
- Version / remarks:
- 14 Mar. 2017
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Supplier: Japan Finechem Company, Inc. Japan
- Lot No.of test material: 7E18
- Expiration date of the lot/batch: 14 Sept. 2017 (3 months after receipt)
- Purity: 99.98%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (27 Jun. 2017 - 3 Jul. 2017), Refrigerator (3 Jul 2017 - 18 Aug. 2017)
OTHER SPECIFICS:
- Appearance: White powder - 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: 175.4 - 210.4 g
- Fasting period before study: Overnight for 16 h
- Housing: Individually, in stainless wire mesh cage, 260Wx350Dx210H (mm)
- Diet: ad libitum, pelleted rodent chow (Teklad Ceritified Irradiated Global 10% Protein Rodent Diet 2918C), Envigo RMS, Inc. U.S.A.
- Water: ad libitum, public tap water in Cheongju-si was filtered and irradiated
- Acclimation period: All animals were quarantined for 3 days. Then, they were moved and acclimated for 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 - 23.3 (permissible value: 19.0 - 25.0)
- Humidity (%): 46.4 - 58.4 (permissible value: 30.0 - 70.0%)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Name: Water for injection
- Storage condition: Room temperature
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 3 mL
- Manufacturer: JW Pharmaceutical Co., Ltd., Republic of Korea
CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level for this study was selected as 300 mg/kg because there is no available toxicity information on the test substance. - Doses:
- - Group 1 and 2: 300 mg/kg bw
- Group 3 and 4: 2000 mg/kg bw - No. of animals per sex per dose:
- 3 animals per group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- All animals were observed for mortality general condition and clinical signs at 30 min after dosing at at 1, 2, 4 and 6 hours after dosing oond day 0 and once daily thereafter for 14 days.
- Body weight was recorded prior to dosing, on day 0, 1, 3, 7 and on the day of necropsy (day 14).
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis performed.
Mean scores and values were determined. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths at the dose of 300 mg/kg while 3 animals died at the dose of 2000 mg/kg (one animal in group 3 and 2 animals in group 4).
- Clinical signs:
- other: - Lacrimation was observed at the dose of 300 mg/kg in 3 animals at 0.5, 1, and/or 2 h after dosing. Lacrimation and salivation were observed at the dose of 300 mg/kg in one animal at 0.5 h after dosing. Chromaturia (orange) was observed in all animals on
- Gross pathology:
- No grossly visible abnormalities were observed in any animal at 300 and 2000 mg/kg.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 was determined to be > 300 - < 2000 mg/kg bw.
- Executive summary:
In this GLP compliant study, performed according to OECD guideline 423, the potential toxicity of the test substance was determined. 4 groups of 3 female 8 -9 week old Sprague-Dawley rats were exposed to the test substance via oral gavage. The animals received the test substance via a single administration of either 300 or 2000 mg/kg bw. A dose of 300 mg/kg bw was administrated to group 1. As no mortality was observed in this group, another group received the dose of 300 mg/kg bw. No mortality was observed in this group. Thus, as dose of 2000 mg/kg bw was administered to the third group. Of this group 1 animal died. A dose of 2000 mg/kg bw was administered to the fourth group. 2 animals of this group died. 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. There were no deaths of animals at 300 mg/kg bw. Lacrimation and/or salivation were overserved in animals of the day of dosing and chromaturia (orange) was observed in Day 1. These changes disappeared in Day 2. No test substance-related effects were observed in body weight data or necropsy findings in any animal at 3000 mg/kg bw. 3 animals were found dead at 2000 mg/kg bw on Day 1. In surviving animals at 2000 mg/kg bw, lacrimation, salivation and/or chromaturia (orange) were observed on the day of dosing, and chromaturia (orange) and/or no stool were observed in Day 1 and/or Day 2. These changes all disappeared on Day 3. In dead animals at 2000 mg/kg, clinical signs of lacrimation, salivation, and/or chromaturia (orange) were observed before death. A decrease in body weight was observed in these animals on Day 3. No test substance-related effects were observed in necropsy findings in any animal at 2000 mg/kg bw. Based on the results of the acute oral toxicity study the LD50 was determined to be >300 - <2000 mg/kg bw.
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral
In a GLP compliant study, performed according to OECD guideline 423, the potential toxicity of the test substance was determined. 4 groups of 3 female 8 -9 week old Sprague-Dawley rats were exposed to the test substance via oral gavage. The animals received the test substance via a single administration of either 300 or 2000 mg/kg bw. A dose of 300 mg/kg bw was administrated to group 1. As no mortality was observed in this group, another group received the dose of 300 mg/kg bw. No mortality was observed in this group. Thus, as dose of 2000 mg/kg bw was administered to the third group. Of this group 1 animal died. A dose of 2000 mg/kg bw was administered to the fourth group. 2 animals of this group died. 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. There were no deaths of animals at 300 mg/kg bw. Lacrimation and/or salivation were overserved in animals of the day of dosing and chromaturia (orange) was observed in Day 1. These changes disappeared in Day 2. No test substance-related effects were observed in body weight data or necropsy findings in any animal at 3000 mg/kg bw. 3 animals were found dead at 2000 mg/kg bw on Day 1. In surviving animals at 2000 mg/kg bw, lacrimation, salivation and/or chromaturia (orange) were observed on the day of dosing, and chromaturia (orange) and/or no stool were observed in Day 1 and/or Day 2. These changes all disappeared on Day 3. In dead animals at 2000 mg/kg, clinical signs of lacrimation, salivation, and/or chromaturia (orange) were observed before death. A decrease in body weight was observed in these animals on Day 3. No test substance-related effects were observed in necropsy findings in any animal at 2000 mg/kg bw. Based on the results of the acute oral toxicity study the LD50 was determined to be >300 - <2000 mg/kg bw (Biotoxtech Co, 2017)
Justification for classification or non-classification
Based on the results obtained from the acute toxicity via the oral route, the substance is classified as Acute Tox. 4, H302: Harmful if swallowed, according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No.1272/2008.
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