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EC number: 204-526-3 | CAS number: 122-18-9
- 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 test chemical. The LD50 value is 1300 mg/kg bw. The study concluded that LD50 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 1.24E-008 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 different studies conducted on rats for the test chemical. The LD50 value is 1300 mg/kg bw. The study concluded that LD50 value is between 1000-2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” 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:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- Data is from Danish QSAR.
- Qualifier:
- according to guideline
- Guideline:
- other: Predicted data
- Principles of method if other than guideline:
- Prediction is done by using Danish QSAR
- 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:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 1300 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
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality observed
- Mortality:
- not specified
- Clinical signs:
- not specified
- Body weight:
- not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 was estimated to be 1300 mg/kg bw, when rats were treated with the given test chemical via oral route.
- Executive summary:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for the given test chemical. The LD50 was estimated to be 1300 mg/kg bw with Reliability Index 0.61 (0.5-0.75 = moderate prediction quality), when rats were treated with the given test chemical via oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 300 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from prediction report.
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
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 acute dermal toxicity studies as- WoE 2 and WoE 3.
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:
- rat
- Strain:
- other: 1. white rats 2. not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 1. not specified
2. TEST ANIMALS
- Age at study initiation: Adult rats
- Weight at study initiation: At the time of dosing the animals weighed between 200 and 270 g.
- Acclimation period: Rats were acclimatized for 5 days before dosing. - Type of coverage:
- other: 1. Dermal 2. occlusive
- Vehicle:
- other: 1. Aqueous solution 2. distilled water
- Details on dermal exposure:
- 1. TEST SITE
- Area of exposure: Shaved skin of the stomach
- % coverage: 4 cm2 in area
2. TEST SITE
- Area of exposure: The sample was spread over as large an area of the trunk
- % coverage: Appropriate amounts of test substances were weighed and applied on a body weight basis
- Type of wrap if used: The area was secured with double-layered gauze bandaging tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): all coverings were removed and any remaining test material was wiped off.
- Time after start of exposure:24-hr
TEST MATERIAL
- For solids, paste formed: yes - Duration of exposure:
- 1. 4-day exposure
2. 24-hr - Doses:
- 1. Range of 1224-1647 mg/kg
2. Range of 960-1750 mg/kg - No. of animals per sex per dose:
- 1. not specified
2. five animals per group - Control animals:
- not specified
- Details on study design:
- 1. - Other examinations performed: Animals were observed for clinical signs.
2. - Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for clinical signs, body weight changes. - Statistics:
- 1. Calculation of the mean lethal dose (LD50) was carried out by the probit analysis method of Litchfield and Wilcoxon.
2. LD50 value was calculated by the moving average method of Thompson (1947). - Preliminary study:
- 1. not specified
2. Preliminary range finding study was performed. - Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 420 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 224 - 1 647
- Remarks on result:
- other: 50% mortality was observed
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 960 - 1 750
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 1. 50% mortality was observed at 1420 mg/kg bw.
2. 50% mortality was observed at 1300 mg/kg bw. - Clinical signs:
- 1. Behavioral changes were observed such as, somnolence (general depressed activity) and hemorrhage was observed.
2. Topical administration caused localized effects, including erythema, edema, desquamation, necrosis, and scab formation; generalized toxic symptoms included sluggishness and reddish nasal and ocular discharges were observed. - Body weight:
- 1. not specified
2. Body weight gains of animals subjected to test chemical was within normal limits. - Gross pathology:
- 1. not specified
2. Gross necropsy did not reveal any significant changes related to the test compound. - Other findings:
- 1. not specified
2. not specified - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- According to CLP regulation, the test chemical can be classified in "Category 4" for acute dermal toxicity, as the LD50 value is between 1000-2000 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 rats for test chemical. The studies are summarized as below –
1. Acute Dermal toxicity study of the given test chemical was conducted in white rats at the concentration range of 1224-1647 mg/kg bw. The given test chemical was applied as aqueous solutions to the shaved skin of the stomach of white rats 4 cm2 in area with a 4-day exposure. Animals were observed for clinical signs. Calculation of the mean lethal dose (LD50) was carried out by the probit analysis method of Litchfield and Wilcoxon. 50% mortality was observed at 1420 mg/kg bw. Behavioural changes were observed such as, somnolence (general depressed activity) and haemorrhage was observed. Hence, LD50 value was considered to be 1420 mg/kg bw, with 95% confidence limit of 1224-1647 mg/kg bw, when white rats were treated with the given test chemical by dermal application.
2. Acute Dermal toxicity study of the given test chemical was conducted in group of 5 male rats at the concentration range of 960-1750 mg/kg bw. Preliminary range finding study was performed. 24 hours before dosing the entire trunk area of each rat was clipped free of hair. Appropriate amounts of test substances were weighed and applied on a body weight basis by moistening the sample with distilled water to form a paste. The sample was spread over as large an area of the trunk as possible and secured with double-layered gauze bandaging tape. After a 24-hr exposure period, all coverings were removed and any remaining test material was wiped off. Necropsy of survivors performed. Animals were observed for clinical signs, body weight changes.LD50 value was calculated by the moving average method of Thompson (1947). 50% mortality was observed at 1300 mg/kg bw. Topical administration caused localized effects, including erythema, edema, desquamation, necrosis, and scab formation; generalized toxic symptoms included sluggishness and reddish nasal and ocular discharges were observed. Body weight gains of animals subjected to test chemical was within normal limits. Gross necropsy did not reveal any significant changes related to the test compound. Hence, LD50 value was considered to be 1300 mg/kg bw, with 95% confidence limit of 960-1750 mg/kg bw, when group of 5 male rats were treated with test chemical by dermal application occlusively for 24-hr.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is between 1000-2000 mg/kg bw, for acute dermal 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 300 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from authoritative database.
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 test chemical. The studies are summarized as below –
1. Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for the given test chemical. The LD50 was estimated to be 1300 mg/kg bw with Reliability Index 0.61 (0.5-0.75 = moderate prediction quality), when rats were treated with the given test chemical via oral route.
2. Acute oral toxicity study was performed using test chemical in male rats at the dose concentration of 1100 mg/kg bw. 50% mortality was observed at dose 1100 mg/kg bw. Hence, LD50 value was considered to be 1100 mg/kg bw, when male rats were treated with test chemical orally.
3. Acute oral toxicity study was performed in rats using test chemical. 50% mortality was observed at dose 1250 mg/kg bw. Hence, LD50 value was considered to be 1250 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 LD50 value is between 300-2000 mg/kg bw. 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 1.24E-008 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:
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 for test chemical. The studies are summarized as below –
1. Acute Dermal toxicity study of the given test chemical was conducted in white rats at the concentration range of 1224-1647 mg/kg bw. The given test chemical was applied as aqueous solutions to the shaved skin of the stomach of white rats 4 cm2 in area with a 4-day exposure. Animals were observed for clinical signs. Calculation of the mean lethal dose (LD50) was carried out by the probit analysis method of Litchfield and Wilcoxon. 50% mortality was observed at 1420 mg/kg bw. Behavioural changes were observed such as, somnolence (general depressed activity) and haemorrhage was observed. Hence, LD50 value was considered to be 1420 mg/kg bw, with 95% confidence limit of 1224-1647 mg/kg bw, when white rats were treated with the given test chemical by dermal application.
2. Acute Dermal toxicity study of the given test chemical was conducted in group of 5 male rats at the concentration range of 960-1750 mg/kg bw. Preliminary range finding study was performed. 24 hours before dosing the entire trunk area of each rat was clipped free of hair. Appropriate amounts of test substances were weighed and applied on a body weight basis by moistening the sample with distilled water to form a paste. The sample was spread over as large an area of the trunk as possible and secured with double-layered gauze bandaging tape. After a 24-hr exposure period, all coverings were removed and any remaining test material was wiped off. Necropsy of survivors performed. Animals were observed for clinical signs, body weight changes.LD50 value was calculated by the moving average method of Thompson (1947). 50% mortality was observed at 1300 mg/kg bw. Topical administration caused localized effects, including erythema, edema, desquamation, necrosis, and scab formation; generalized toxic symptoms included sluggishness and reddish nasal and ocular discharges were observed. Body weight gains of animals subjected to test chemical was within normal limits. Gross necropsy did not reveal any significant changes related to the test compound. Hence, LD50 value was considered to be 1300 mg/kg bw, with 95% confidence limit of 960-1750 mg/kg bw, when group of 5 male rats were treated with test chemical by dermal application occlusively for 24-hr.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is between 1000-2000 mg/kg bw, for acute dermal 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.
Justification for classification or non-classification
Based on the above studies on test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity and LD50 value is between 1000-2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.
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