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EC number: 203-273-6 | CAS number: 105-13-5
- 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 and mice for the given test chemical. The LD50 value is 1200 mg/kg bw. The study concluded that the LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” 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 0.0018 mmHg. 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 rats and rabbits for the test chemical. The LD50 value is 3000 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 study of the given test chemical was performed in rat.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: 18 hour fasted - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 1.2 ml/kg (approximately 1.34 g/kg).
- No. of animals per sex per dose:
- 50
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 6 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical signs. - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 50% mortality was observed at 1200 mg/kg bw in treated animals.
- Clinical signs:
- other: Severe depression and dyspnoea were reported prior to death.
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Acute oral toxicity dose (LD50) value was considered to be 1200 mg/kg bw, when 50 rats were treated with the given test chemical via oral route.
- Executive summary:
Acute oral toxicity study was conducted by using the given test chemical in 50 rats at the dose concentration of 1.2 ml/kg (approximately 1.34 g/kg).
Animals were observed for mortality and clinical signs for 6 days.
50% mortality was observed at 1200 mg/kg bw in treated animals. Severe depression and dyspnoea were reported prior to death.
Hence, the LD50 value was considered to be 1200 mg/kg bw, when 50 rats were treated with the given test chemical via oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 200 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:
- study scientifically not necessary / other information available
- 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:
- 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 dermal toxicity study of the given test chemical was performed in rabbit.
- 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:
- not specified
- Type of coverage:
- other: Dermal
- Vehicle:
- not specified
- Details on dermal exposure:
- not specified
- Duration of exposure:
- not specified
- Doses:
- 1.25, 2.5, and 5.0 g/kg.
- No. of animals per sex per dose:
- Groups of four rabbits
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 6 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical signs. - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 940 - 4 060
- Mortality:
- Mortalities included one rabbit from the 2.5 g/kg group on day 1, and all four rabbits from the 5.0 g/kg group by day 6.
- Clinical signs:
- other: Clinical signs of toxicity included loss of coordination and muscle tone in two animals at 5.0 g/kg and one animal at 2.5 g/kg. Slight to moderate erythema and edema was also observed in all animals.
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute dermal toxicity dose (LD50) value was considered to be 3.0 g/kg, with 95% confidence limits of 1.94–4.06 g/kg, when Groups of four rabbits were treated with the given test chemical by dermal application.
- Executive summary:
Acute dermal toxicity study was conducted by using the given test chemical in Groups of four rabbits at the dose concentration of 1.25, 2.5, and 5.0 g/kg. Animals were observed for mortality and clinical signs for 6 days.
Mortalities included one rabbit from the 2.5 g/kg group on day 1, and all four rabbits from the 5.0 g/kg group by day 6. Clinical signs of toxicity included loss of coordination and muscle tone in two animals at 5.0 g/kg and one animal at 2.5 g/kg. Slight to moderate erythema and edema was also observed in all animals.
Hence, the LD50 value was considered to be 3.0 g/kg, with 95% confidence limits of 1.94–4.06 g/kg, when Groups of four rabbits were treated with the given test chemical by dermal application.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 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 the given test chemical. The studies are summarized as below –
The acute oral toxicity study was mentioned in peer-reviewed journals, handbook, authoritative databases and secondary reports and conducted to assess the toxicological profile of the given test chemical in 50 rats at the dose concentration of 1.2 ml/kg (approximately 1.34 g/kg). Animals were observed for mortality and clinical signs for 6 days. 50% mortality was observed at 1200 mg/kg bw in treated animals. Severe depression and dyspnoea were reported prior to death. Hence, the LD50 value was considered to be 1200 mg/kg bw, when 50 rats were treated with the given test chemical via oral route.
The above study report is supported with another study mentioned in different publications, handbooks, authoritative databases and secondary reports for the given test chemical. The oral toxicity study was conducted by using the given test chemical in 90 mice at the dose concentration of 1.6 ml/kg (approximately 1.78 g/kg). Animals were observed for mortality and clinical signs for 6 days. 50% mortality was observed at 1600 mg/kg bw in treated animals. Severe depression and dyspnoea were reported prior to death. Hence, the LD50 value was considered to be 1600 mg/kg bw, when 90 mice were treated with the given test chemical via oral route.
All these studies are supported with the data available in publication, different handbooks and authoritative database for the test chemical. The acute oral toxicity study was conducted in rats at the dose concentration of 1400 mg/kg bw. Animals were observed for mortality and clinical signs. 50% mortality was observed at 1400 mg/kg bw. The observed effects were haematological Changes, anaemia and nephrotoxicity. Hence, the LD50 value was considered to be 1400 mg/kg bw, when rats were treated with the given test chemical via oral route.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” 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 0.0018 mmHg. 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 rats and rabbits for test chemical. The studies are summarized as below -
The reported study was mentioned in peer-reviewed journals and authoritative databases and conducted to determine acute dermal toxicity dose for the given test chemical in Groups of four rabbits at the dose concentration of 1.25, 2.5, and 5.0 g/kg.
Animals were observed for mortality and clinical signs for 6 days. Mortalities included one rabbit from the 2.5 g/kg group on day 1, and all four rabbits from the 5.0 g/kg group by day 6. Clinical signs of toxicity included loss of coordination and muscle tone in two animals at 5.0 g/kg and one animal at 2.5 g/kg. Slight to moderate erythema and edema was also observed in all animals.
Hence, the LD50 value was considered to be 3.0 g/kg, with 95% confidence limits of 1.94–4.06 g/kg, when Groups of four rabbits were treated with the given test chemical by dermal application.
Another study mentioned in publications, authoritative database and secondary report was carried out to determine the acute dermal toxicity dose by using the given test chemical in 10 mice at the dose concentration of 10000 mg/kg bw. Animals were observed for mortality. No mortality was observed at10000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be >10000 mg/kg bw, when 10 mice were treated with the given test chemical by dermal application.
All the above studies are further supported with the data available in publications, authoritative databases and different handbooks for the given test chemical. The acute dermal toxicity study was conducted in rats at the dose concentration of 3200 mg/kg bw. 50% mortality was observed at 3200 mg/kg bw. Hence, the LD50 value was considered to be 3200 mg/kg bw, when rats were treated with the given test chemical by dermal application.
Thus, based on the above summarised studies for test chemical, it can be 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.
Justification for classification or non-classification
Based on the above studies for the test chemical, it can be concluded that LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity and the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this range and value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity and cannot be classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.
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