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EC number: 208-719-3 | CAS number: 539-48-0
- 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:
The LD50 of this substance was estimated to range between 500 and 2000 mg/kg bw in both male and female rats.
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 2000-01-18 to 2000-02-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Purity: 99.9%
Lot No.: Lot 4 - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Japan, Inc.
- Age at study initiation: 5 weeks
- Weight at study initiation: 116±4.4 g (males), 98±3.7 g (females)
- Fasting period before study: fasted overnight
- Housing: Animals were reared in suspended metallic cages for rats, 6-10 per cage.
- Diet (e.g. ad libitum): pellet food for rat MF
- Water (e.g. ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2
- Humidity (%): 55±6
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.25, 0.5, 2, 5 and 20 (w/v)%
- Dose volume: 1.0 mL/100 g of body weight - Doses:
- 25, 50, 200, 500 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily with respect to mortality and general signs and symptoms during the 14-day study period after administration. Animals were weighed shortly before administration on day 0 (day of administration) and day 2, 7 and 14 using an electronic balance.
- Necropsy of survivors performed: Dead animals were necropsied promptly after discovery. Surviving animals were necropsied upon completion of the study (on day 15) after exsanguinating them to death by cutting the abdominal aorta under anesthesia with diethyl ether. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No male died in the 25, 50, 200 or 500 mg/kg group, while all males died on day 0 in the 2000 mg/kg group.
No female died in the 25, 50, 200 or 500 mg/kg group, while all females died on day 0 in the 2000 mg/kg group. - Clinical signs:
- Males showed no abnormality in the 25, 50 or 200 mg/kg group. In the 500 mg/kg group, brown loose stools were observed on stool pans on day 1 and 2, but no abnormality was noted thereafter. In the 2000 mg/kg group, some animals showed drooping body about 10 min after administration with all 6 animals showing drooping body and sedation 30 min after administration, followed later by writhing, abnormal breath sounds and red fluid attached to the nose in one animal each. Drooping body and blepharoptosis lasted thereafter, gradually followed by decreases in motor activity, collapse and pallor. All animals died by 5.5 hours after administration. Two of the dead animals showed soilage around the anus probably attributable to diarrhea.
Females showed no abnormality in the 25, 50 or 200 mg/kg group. In the 500 mg/kg group, 2 females had diarrhea 5 hours after administration, but recovery was seen the following day and no abnormality was seen thereafter. In the 2000 mg/kg group, all 6 females showed drooping body and sedation 30 min after administration. Drooping body and blepharoptosis persisted thereafter, followed by gradual decreases in motor activity. All 6 females died by 6 hours after administration showing collapse and pallor. - Body weight:
- Males in 25, 50 and 200 mg/kg groups showed changes in body weight similar to those seen in the control group (given only distilled water). In the 500 mg/kg group, slight inhibition in body weight gain was observed on day 2, but normal weight gain tendency was observed thereafter with changes in body weight similar to those observed in the control group.
In females in 25, 50, 200 and 500 mg/kg groups, changes in body weight similar to those observed in the control group were observed. - Gross pathology:
- All dead males in the 2000 mg/kg group showed severe hemorrhage from the glandular stomach mucosa and hemorrhage from the intestinal mucosa. No abnormality was observed in any animal that survived the study in 25, 50, 200 and 500 mg/kg groups.
In females, all dead animals in the 2000 mg/kg group showed severe hemorrhage from the glandular stomach and intestinal mucosa with two also showing hemorrhage/hyperemia in the anterior stomach mucosa. No abnormality was observed in any animal that survived the study in 25, 50, 200 and 500 mg/kg groups. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of this substance was estimated to range between 500 and 2000 mg/kg bw in both male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 1
Additional information
Oral:
One study is available which according to OECD 401. The test substance was administrated to male and female rats at doses of 25, 50, 200, 500 and 2000 mg/kg bw. No animal died in the 25, 50, 200 or 500 mg/kg group, while all animals died on day 0 in the 2000 mg/kg group. All dead animals in the 2000 mg/kg group showed severe hemorrhage from the glandular stomach mucosa and intestinal mucosa.
The LD50 of this substance was estimated to range between 500 and 2000 mg/kg bw in both male and female rats.
Justification for classification or non-classification
Oral LD50: 500 -2000 mg/kg bw
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1, this substance should be classified as Acute toxicity Category 4.
Specific target organ toxicity-single exposure:
No significant non-lethal toxic effects observed in acute oral toxicity study.
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1, this substance should not be classified for this endpoint.
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