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EC number: 238-942-1 | CAS number: 14871-79-5
- 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
Acute oral toxicity:
The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The study concluded that the LD50 value is >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 acute oral toxicity studies as- WoE 2 and WoE 3.
Acute oral toxicity test was carried out to study the effects of the test chemicals on rodents. - GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 2. - Fasting period before study: Fasting was done.
3. not specified - Route of administration:
- other: 2. oral: gavage 3. oral: unspecified
- Vehicle:
- other: 2. water 3. unchanged (no vehicle)
- Details on oral exposure:
- 2. MAXIMUM DOSE VOLUME APPLIED: 10 mg/kg body weight.
3. not specified - Doses:
- 2. 0, 2000 and 5000 mg/kg bw
3. 4500 mg/kg - No. of animals per sex per dose:
- 2. 20 males and 10 females
-2000 mg/kg: 10 males
- 5000 mg/kg: 10 males and 10 females
3. not specified - Control animals:
- other: 2. yes 3. not specified
- Details on study design:
- 2. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 14 days following the single administration of the test item
- Necropsy of survivors performed: yes
- Other -examinations performed: Clinical signs, mortality and body weight
3. not specified - Statistics:
- No data
- Preliminary study:
- 2. Based on a previous study (not available) indicating that LD50 was greater than 1000 mg/kg in male rats, the first dose of the test item to be tested in male rats was 2000 mg/kg. The other tested dose-level administered was 5000 mg/kg (1 group of females, 1 group of males).
3. not specified - Sex:
- male
- Dose descriptor:
- LD50
- Remarks:
- 2
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occurred
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- 2
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 3 out of 10 males and 6 out 10 females died on day 2
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- 3
- Effect level:
- 4 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 2. - At 2000 mg/kg , no mortality occurred.
- At 5000 mg/kg, 3 out of 10 males and 6 out 10 females died on day 2.
- In the negative control groups, no deaths occurred.
3. 50% mortality was observed at 4500 mg/kg bw - Clinical signs:
- 2. - In males exposed to 2000 mg/kg, mild depression and piloerection were observed from day 1 (1 hour after dosing) to day 2.
- In males and females exposed to 5000 mg/kg, mild depression and piloerection were observed from day 1 (immediately after dosing) to day 3.
- There were no clinical signs in the negative control groups.
3. not specified - Body weight:
- 2. At 2000 and 5000 mg/kg, body weight gain was similar to controls.
3. not specified - Gross pathology:
- 2. At necropsy, red lungs and stomachs filled with a clear watery fluid were reported in those animals.
3. not specified - Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- The test chemical cannot be classified for acute oral toxicity, as the LD50 value is >5000 mg/kg bw according to CLP regulation.
- Executive summary:
In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for the given test chemical. The studies are summarized as below -
The acute oral toxicity study was conducted for the given test chemical according to methods similar to OPPTS 870.1100 and OECD 401 guidelines in male and female rats. The test chemical was prepared in water and was administered by gavage under a dosage-volume of 10 mL/kg bw to groups of 10 fasted rats. Based on a previous study (not available) indicating that LD50 was greater than 1000 mg/kg in male rats, the first dose of the test chemical to be tested in male rats was 2000 mg/kg. The other tested dose-level administered was 5000 mg/kg (1 group of females, 1 group of males). Negative control groups receiving water only were included in the study. Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy. At the dose-level of 2000 mg/kg, no mortality occurred. Mild depression and piloerection were observed from day 1 (1 hour after dosing) to day 2. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy. At the dose- level of 5000 mg/kg, 3 out 10 males and 6 out 10 females were found dead on day 2. At necropsy, red lungs and stomachs filled with a clear watery fluid were reported in those animals. In the surviving animals, mild depression and piloerection were observed from day 1 (immediately after dosing) to day 3. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy. Under the experimental conditions of this study, acute oral LD50 of test chemical in male rats was determined to be >5000 mg/kg and in female rats was observed in between 2000-5000 mg/kg bw.
The above study is supported with the data available in authoritative database for the given test chemical. The reported study was designed and conducted to determine the acute oral toxicity profile in rat at the concentration of 4500 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 4500 mg/kg bw. Therefore, the LD50 was considered to be 4500 mg/kg bw, when rats were treated with test chemical via oral route.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from handbook or collection of data.
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 oral toxicity:
In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for the given test chemical. The studies are summarized as below -
The acute oral toxicity study was conducted for the given test chemical according to methods similar to OPPTS 870.1100 and OECD 401 guidelines in male and female rats. The test chemical was prepared in water and was administered by gavage under a dosage-volume of 10 mL/kg bw to groups of 10 fasted rats. Based on a previous study (not available) indicating that LD50 was greater than 1000 mg/kg in male rats, the first dose of the test chemical to be tested in male rats was 2000 mg/kg. The other tested dose-level administered was 5000 mg/kg (1 group of females, 1 group of males). Negative control groups receiving water only were included in the study. Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy. At the dose-level of 2000 mg/kg, no mortality occurred. Mild depression and piloerection were observed from day 1 (1 hour after dosing) to day 2. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy. At the dose- level of 5000 mg/kg, 3 out 10 males and 6 out 10 females were found dead on day 2. At necropsy, red lungs and stomachs filled with a clear watery fluid were reported in those animals. In the surviving animals, mild depression and piloerection were observed from day 1 (immediately after dosing) to day 3. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy. Under the experimental conditions of this study, acute oral LD50 of test chemical in male rats was determined to be >5000 mg/kg and in female rats was observed in between 2000-5000 mg/kg bw.
The above study is supported with the data available in authoritative database for the given test chemical. The reported study was designed and conducted to determine the acute oral toxicity profile in rat at the concentration of 4500 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 4500 mg/kg bw. Therefore, the LD50 was considered to be 4500 mg/kg bw, when rats were treated with test chemical via oral route.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Justification for classification or non-classification
Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
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