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EC number: 223-772-2 | CAS number: 4065-45-6
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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 LD50 value is 3530 mg/kg bw. The studies 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 low vapour pressure of the test chemical, which is reported to be 1.79E-009 Pa. 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 study 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 study was conducted by using the given test chemical in rodent.
- 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
- Diet (e.g. ad libitum): food, ad libitum
- Water (e.g. ad libitum): water, ad libitum; - Route of administration:
- oral: gavage
- Vehicle:
- other: Agar/Tween
- Details on oral exposure:
- not specified
- Doses:
- 1.25 - 10 g/kg
- No. of animals per sex per dose:
- Total = 20
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed and dosed after a one-week observation.Rats were observed daily for 7 to 14 days.
- Necropsy of survivors performed: yes, animals were sacrificed and autopsied for gross pathology. - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 530 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 50% mortality was observed at 3530 mg/kg bw.
- Clinical signs:
- other: Clinical signs was observed such as Ataxia.
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute oral toxicity dose (LD50) value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.
- Executive summary:
The acute oral toxicity study was conducted by using the given test chemical in 20 rats at the dose concentration of 1.25 - 10 g/kg via oral route. The given test chemical was dissolved in Agar/Tween. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. 50% mortality was observed at 3530 mg/kg bw. Clinical signs was observed such as ataxia.
Hence, the LD50 value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 530 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 was conducted by using the given test chemical in rodent.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- not specified
- Type of coverage:
- other: Dermal
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test substance was applied to the epilated skin of the back or flanks
REMOVAL OF TEST SUBSTANCE
- Washing (if done): it was then washed off.
- Time after start of exposure: 18-24 hours - Duration of exposure:
- 18-24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total = 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made daily for signs of toxicity and irritation.
- Necropsy of survivors performed: yes, animals were autopsied following the 5- to 7-day observation period. - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 5000 mg/kg bw.
- Clinical signs:
- other: There were no gross signs of toxicity or irritation throughout the observation period;
- Gross pathology:
- Autopsy revealed one animal with congested kidneys.
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute dermal toxicity dose (LD50) value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.
- Executive summary:
The acute dermal toxicity study was conducted by using the given test chemical in 10 albino rabbits at the dose concentration of 5000 mg/kg bw. The test substance was applied to the epilated skin of the back or flanks and held in contact for 18-24 hours; it was then washed off. Observations were made daily for signs of toxicity and irritation. Animals were autopsied following the 5- to 7-day observation period. No mortality was observed at 5000 mg/kg bw. There were no gross signs of toxicity or irritation throughout the observation period. Autopsy revealed one animal with congested kidneys.
Hence, the LD50 value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.
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 for the given test chemical. The studies are summarized as below –
The reported study was mentioned in publication, handbook and different authoritative databases and conducted to assess the toxicological profile of the test chemical in 20 rats at the dose concentration of 1.25 - 10 g/kg via oral route. The given test chemical was dissolved in Agar/Tween. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. 50% mortality was observed at 3530 mg/kg bw. A clinical sign was observed such as ataxia. Hence, the LD50 value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.
The above study is supported with another study mentioned in publication for the given test chemical. The acute oral toxicity study was conducted in 15 rats at the dose concentration of 2.5-10 g/kg via oral route. The given test chemical was dissolved in Water/agar/tween. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. 50% mortality was observed at 6150 mg/kg bw. Hence, the LD50 value was considered to be 6150 mg/kg bw, when 15 rats were treated with the given test chemical via oral route.
These studies are further supported with the data available in publication for the given test chemical. The acute oral toxicity study was conducted in 30 rats at the dose concentration of 0.2 - 6.4 g/kg via oral route. The given test chemical was dissolved in water. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. No mortality was observed at 6400 mg/kg bw. Hence, the LD50 value was considered to be >6400 mg/kg bw, when 30 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 >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 low vapour pressure of the test chemical, which is reported to be 1.79E-009 Pa. 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 reported study was mentioned in publication and conducted by using the given test chemical in 10 albino rabbits at the dose concentration of 5000 mg/kg bw. The test substance was applied to the epilated skin of the back or flanks and held in contact for 18-24 hours; it was then washed off. Observations were made daily for signs of toxicity and irritation. Animals were autopsied following the 5- to 7-day observation period. No mortality was observed at 5000 mg/kg bw. There were no gross signs of toxicity or irritation throughout the observation period. Autopsy revealed one animal with congested kidneys. Hence, the LD50 value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.
Justification for classification or non-classification
Based on the above studies for the test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity and acute dermal toxicity. Thus, comparing these values 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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