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EC number: 254-599-0 | CAS number: 39711-79-0
- 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
Acute oral toxicity:
The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is 2900 mg/kg bw. The study concluded that the 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.
Acute Inhalation Toxicity:
The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0072 Pa (5.4004433e-5 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute Dermal toxicity:
The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity dose for the substance was determined in rats.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 10% suspension in 0.5% carboxymethylcellulose
- Details on oral exposure:
- not specified
- Doses:
- 2900 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
- Preliminary study:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 400 - 3 400
- Mortality:
- 50% mortality was observed at 2900 mg/kg bw in treated animals.
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral LD50 value was determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.
- Executive summary:
The acute oral toxicity study was conducted by using of the given test chemical inmale and female CFY rats at the dose concentration of 2900 mg/kg bw.
The given test chemical was prepared as 10% suspension in 0.5% carboxymethylcellulose and administered via oral route.
The animals were observed for mortality. 50% mortality was observed at 2900 mg/kg bw in treated animals.
Hence, the LD50 valuewas determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 900 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from publication.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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
- 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 3 acute dermal toxicity studies as- WoE 2, WoE 3 and WoE 4.
Acute dermal 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:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 1. not specified
2. not specified
3. not specified - Type of coverage:
- other: Dermal
- Vehicle:
- not specified
- Details on dermal exposure:
- 1. not specified
2. not specified
3. not specified - Duration of exposure:
- 1. not specified
2. not specified
3. not specified - Doses:
- 1. 5000 mg/kg bw
2. 5000 mg/kg bw
3. 5000 mg/kg bw - No. of animals per sex per dose:
- 1. not specified
2. not specified
3. not specified - Control animals:
- not specified
- Details on study design:
- 1. not specified
2. not specified
3. not specified - Statistics:
- 1. not specified
2. not specified
3. not specified - Preliminary study:
- 1. not specified
2. not specified
3. not specified - Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- 1. No mortality was observed in treated rabbits at 5000 mg/kg bw
2. No mortality was observed at 5000 mg/kg bw.
3. No mortality was observed in trreated rabbits at 5000 mg/kg bw - Clinical signs:
- other: 1. not specified 2. not specified 3. not specified
- Gross pathology:
- 1. not specified
2. not specified
3. not specified - Other findings:
- 1. not specified
2. not specified
3. not specified - Interpretation of results:
- other: Not classified
- Conclusions:
- According to CLP regulation, the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >5000 mg/kg bw.
- Executive summary:
In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rabbits for test chemical. The studies are summarized as below –
The acute dermal toxicity study was conducted by using the given test chemical in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical by dermal application.
The above study is supported with another study mentioned in publication and database for the test chemical. The acute dermal toxicity study of test chemical was conducted on rabbits at the dose concentration of 5000 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. No mortality was observed at a dose level of 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical via dermal application.
Both the above studies are further supported with the study mentioned in publication. In an acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg bw when rabbits were treated with test chemical by dermal application.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal 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 publication.
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 and mice for test chemical. The studies are summarized as below –
The acute oral toxicity study was conducted by using of the given test chemical in male and female CFY rats at the dose concentration of 2900 mg/kg bw. The given test chemical was prepared as 10% suspension in 0.5% carboxymethyl cellulose and administered via oral route. The animals were observed for mortality. 50% mortality was observed at 2900 mg/kg bw in treated animals. Hence, the LD50 value was determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.
The above study is supported with another study mentioned in review article, publication and secondary source for the given test chemical. The acute oral toxicity study was conducted by using of the given test chemical in CD-albino mice at the dose concentration of 5300 mg/kg bw. The animals were observed for mortality. 50% mortality was observed at 5300 mg/kg bw in treated animals. Hence, the LD50 value was determined to be 5300 mg/kg bw, when CD-albino mice were treated with the given test substance via oral gavage route.
These studies are supported with the study mentioned in handbook and authoritative database for the test chemical. The acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 3300 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. 50% mortality was observed at a dose level of 3300mg/kg bw. Therefore, LD50 value was considered to be 3300 mg/kg bw, when rats were treated with test chemical via oral route.
All the above studies are further supported with the study mentioned in publication and database for the test chemical. The acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 3180 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. 50% mortality was observed at a dose level of 3180 mg/kg bw. Therefore, LD50 value was considered to be 3180 mg/kg bw, when rats were treated with test chemical orally.
Thus, based on the above summarised studies on test chemical, it can be concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Acute Inhalation Toxicity:
The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0072 Pa (5.4004433e-5 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute Dermal Toxicity:
In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rabbits for test chemical. The studies are summarized as below –
The acute dermal toxicity study was conducted by using the given test chemical in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical by dermal application.
The above study is supported with another study mentioned in publication and database for the test chemical. The acute dermal toxicity study of test chemical was conducted on rabbits at the dose concentration of 5000 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. No mortality was observed at a dose level of 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical via dermal application.
Both the above studies are further supported with the study mentioned in publication. In an acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg bw when rabbits were treated with test chemical by dermal application.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal 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 and acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.
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