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EC number: 201-732-5 | CAS number: 87-22-9
- 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 toxicity- ORAL
In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.
Acute toxicity- Dermal
An acute dermal toxicity study was performed to evaluate the toxic potential of the test chemical in rabbits. Nine rabbits received a single dermal application of neat test chemical at a dose of 5 g/kg. The rabbits were observed for mortality and/or systemic effects for 14 days. No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.
Acute toxicity- Inhalation
The study doesnot need to be conducted because exposure of humans via inhalation route is not likely taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles, or droplets of an inhalable size. The test chemical has very low vapor pressure < 0.1333 Pa at 20°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a peer-reviewed publication.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Equivalent or similar to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No Data Available
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- single exposure
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?)
: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no : no
- Clinical signs including body weight : yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- No Data Available
- Preliminary study:
- No Data Available
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality due to the administration of the test chemical was observed at the given doses. However, one death was observed.
- Clinical signs:
- other: Slight lethargy was observed at the administered doses.
- Gross pathology:
- No Data Available
- Other findings:
- No Data Available
- Interpretation of results:
- other: Not Classified
- Conclusions:
- Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Klimisch Rating 2
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- 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 a peer reviewed journal.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Equivalent or similar to OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No Data Available
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Nine rabbits received a single dermal application of neat test chemicals at a dose of 5 g/kg.
- Duration of exposure:
- Single exposure (24 hours)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 9 rabbits were used in this study.
- Control animals:
- not required
- Details on study design:
- No Data Available
- Statistics:
- No Data Available
- Preliminary study:
- No Data Available
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at any given doses.
- Clinical signs:
- other: No clinical sgns were observed at the tested doses.
- Gross pathology:
- No Data Available
- Other findings:
- No Data Available
- Interpretation of results:
- other: not classified
- Conclusions:
- No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.
- Executive summary:
An acute dermal toxicity study was performed to evaluate the toxic potential of the test chemical in rabbits.Nine rabbits received a single dermal application of neat test chemical at a dose of 5 g/kg. The rabbits were observed for mortality and/or systemic effects for 14 days. No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Klimisch Rating 2
Additional information
Acute toxicity- Oral
Various studies have been reviewed to determine the acute oral LD50 of the test chemical. These include in vivo experimental studies performed on rats for the test chemical. The results are mentioned below:
In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.
This result is supported by an Acute Oral Toxicity Study of the test chemical in Rats, conducted as per OECD No. 423. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing) 7 and 14. Body weight gain was observed in all the animals treated with 2000 mg/kg body weight, during the 14 day observation period, as compared to day 0. At 2000 mg/kg, animal nos. 1, 2, 3, 5 and 6 were observed normal throughout the experimental period, whereas animal no. 4 was observed normal at 30 minutes, 1, 2, 3 and 4 hours, with mild ataxia from day 1 to 4, with mild tremors on day 1, with mild chromodacryorrhea from day 2 to 6 and with moderate to mild lethargy from day 3 to 9 post dosing followed by normal observation till day 14. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. Based on all the observations and results, the acute oral LD50 (cut-off value) of the test chemical was 5000 mg/kg body weight. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals.
These results are further supported by another acute Oral Toxicity Study of the test chemical conducted as per OECD 423 Guidelines in rats. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, food was withheld but drinking water provided ad libitum. Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of all the animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0. At 2000 mg/kg, all the animals were normal throughout the experimental period. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. Under the conditions of this acute oral toxicity study, the acute oral LD50 value was greater than 2000 mg/kg. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
Based on the available results, the acute oral LD50 for the test chemical can be considered to be > 2000 mg/kg. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
Acute toxicity- Dermal
Various studies have been reviewed to determine the acute dermal LD50 of the test chemical. These include in vivo experimental studies performed on rats, rabbits for the test chemical. The results are mentioned below:
An acute dermal toxicity study was performed to evaluate the toxic potential of the test chemical in rabbits. Nine rabbits received a single dermal application of neat test chemical at a dose of 5 g/kg. The rabbits were observed for mortality and/or systemic effects for 14 days. No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.
This result is supported by an Acute Dermal Toxicity Study was conducted using test chemical as per OECD No.402 in 10 male and female healthy young adult Wistar rats which were randomly selected and used for conducting acute dermal toxicity study at the concentration of 2000 mg/kg bw. Rats free from injury and irritation of skin were selected for the study. 24 hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item was applied by single dermal application and observed for 14 days after treatment. On test day 0, as such amount of test item, calculated based on density (1.0016) and body weight was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating adhesive tape. The porous gauze dressing was wrapped around the abdomen and anchored with non-irritating adhesive tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. No clinical signs and any skin reaction were observed throughout the experimental period in all treated animals. The male and female animals were observed with body weight gain throughout the experiment, except on day 7 male animals were observed with decline in mean body weight gain as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence the LD50 was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application.
These results are further supported by another acute dermal toxicity study for the test chemical conducted as per OECD No. 402 in Wistar Rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight based on the test item density (1.07513) and latest body weight was applied by single dermal application and observed for 14 days after treatment. On test day 0, calculated volume of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24 -hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1 14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. At 2000 mg/kg, all the animals were observed normal throughout the experimental period. Mean body weight was observed with gain on day 7 and 14 of male and female animals, as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Under the conditions of the study, the acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when rats were treated with the test chemical by dermal application.
Based on the available results, the acute dermal LD50 for the test chemical can be considered to be > 2000 mg/kg. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
Acute toxicity- Inhalation
The study doesnot need to be conducted because exposure of humans via inhalation route is not likely taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles, or droplets of an inhalable size. The test chemical has very low vapor pressure < 0.1333 Pa at 20°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely.
Justification for classification or non-classification
Based on the available results, the test chemical is not likely to cause toxicity when exposed via oral, dermal or inhalation route. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
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