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EC number: 207-396-6 | CAS number: 467-63-0
- 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
The acute oral toxicity of test chemical in test animals was observed to be between 300 to 2000 mg/kg body weight. And hence, the test chemical can be classified as Acute toxicity Category 4 according to CLP regulation.
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:
- weight of evidence
- 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 authoritative database.
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity of test chemical 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:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- 770 mg/kg
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- No data
- Preliminary study:
- No data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 770 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality observed
- Mortality:
- 50% mortality observed at 770 mg/kg bw
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity of test chemical in rat was observed to be 770mg/kg body weight.
- Executive summary:
In acute oral toxicity study, rats were treated with test chemical at the concentration of 770mg/kg bw orally. 50% mortality observed in treated rat at 770mg/kg bw. Therefore, LD50 was considered to be 770mg/kg bw when rats were treated with test chemical orally.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 770 mg/kg bw
- Quality of whole database:
- Data is klimish 2 and from authoritative database
Additional information
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. In acute oral toxicity study, rats were treated with test chemical at the concentration of 770mg/kg bw orally. 50% mortality observed in treated rat at 770mg/kg bw. Therefore, LD50 was considered to be 770mg/kg bw when rats were treated with test chemical orally.
2. In acute oral toxicity study, mouse were treated with test chemical at the concentration of 1000 mg/kg bw orally. 50% mortality observed in treated mouse at 1000 mg/kg bw. Therefore, LD50 was considered to be 1000 mg/kg bw when mouse were treated with test chemical orally.
3. The study now reported was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats.
Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 2 hours after the dosing and no mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg resulted in distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 1 hour after the dosing and no mortality after the dosing.
No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in salivation, distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 30 minutes to 6 hours after the dosing. One animal died at 24 hours after the dosing. As one mortality was observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in salivation, distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 30 minutes to 4 hours after the dosing. One animal died on day 3, one animal died on day 5 and one animal died on day 10 after the dosing.
All animals from 300 mg/kg dose group survived through the study period of 14 days and four animals died from 2000 mg/kg dose group after the dosing.
Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg dose group.
Gross pathological examination revealed stomach, small and large intestine with test item coloured mucosa in animals sacrificed terminally from 2000 mg/kg dose group and stomach distended with test item coloured mucosa and small and large intestine distended with liquid test item coloured ingesta in found dead animals from 2000 mg/kg dose group.
The acute oral LD50(Cut-off value) of test chemical was 500 mg/kg body weight.
Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category 4 (300 – ≤ 2000)” criteria of CLP.
4. In acute oral toxicity study, mouse was treated with test chemical at the concentration of 470 mg/kg bw orally. 50% mortality observed in treated rat at 470 mg/kg bw. Therefore, LD50 was considered to be 470 mg/kg bw when mouse was treated with test chemical orally.
5. In acute oral toxicity study, rabbits were treated with test chemical at the concentration of 180 mg/kg bw orally. 50% mortality observed in treated mouse at 180 mg/kg bw. Therefore, LD50 was considered to be 180 mg/kg bw when rabbits were treated with test chemical orally.
Thus from above summarised studies, it can be concluded that test chemical is acutely toxic and falls under category 4.
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. Thus, comparing this value with the criteria of CLP regulation, the given test chemical is classified as Category 4 for acute oral toxicity
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