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EC number: 220-476-5 | CAS number: 2778-96-3
- 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 >2500 mg/kg bw. The study concluded that LD50 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:
Test chemical has very low vapour pressure (2.16E-09 Pa. = 1.620133003827e-11 mmHg),So the potential for the generation of inhalable vapours is very low. Also 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 and therefore the acute inhalation toxicity end point was considered for waiver.
Acute dermal Toxicity:
The acute dermal toxicity dose (LD50) for test chemical was based on data available for the test chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,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:
- 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 for the target chemical 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 for the target CAS is summarized based on data from various test chemicals.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: 2.not specified 3.not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 2.not specified
3.not specified - Route of administration:
- other: 2.oral: unspecified 3.oral: gavage
- Vehicle:
- other: 2.not specified 3.olive oil
- Details on oral exposure:
- 2.not specified
3.VEHICLE
- Concentration in vehicle: 2000 and 2500 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: olive oil - Doses:
- 2.2500 mg/kg bw
3.2000 and 2500 mg/kg bw - No. of animals per sex per dose:
- 2.not specified
3.Total: 15
2000 mg/kg: 5 rat
2500 mg/kg: 10 rat - Control animals:
- not specified
- Details on study design:
- 2.not specified
3.- Duration of observation period following administration: No data available
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality and gross pathology were examined. - Statistics:
- 2.not specified
3.No data available - Preliminary study:
- 2.not specified
3.No data available - Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- 2.
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- 3.
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- 2.No mortality was observed in treated rats at 2500 mg/kg bw
3.No mortality was observed in treated rat at 2000 and 2500 mg/kg bw - Clinical signs:
- other: 2.not specified 3.not specified
- Gross pathology:
- 2.not specified
3.No lesions of the liver, spleen, stomach, or intestines were in treated rat at necropsy in the rats that died during the study or in those killed at the termination of the study. - Other findings:
- 2.not specified
3.not specified - Interpretation of results:
- other: not classified
- Conclusions:
- According to CLP regulation,the test chemical cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.
- Executive summary:
Data available for the test chemical has been reviewed to determine the acute oral toxicity of the test chemical.The studies are as mentioned below:
In a acute oral toxicity study, rats were treated with test chemical orally. No mortality was observed in treated rats at 2500 mg/kg bw.Therefore, LD50 value was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally.
In another acute oral toxicity study, rat were treated with test chemical in the concentration of 2000 and 2500 mg/kg bw in olive oil orally. No mortality was observed in treated rat at 2000 and 2500 mg/kg bw. No lesions of the liver, spleen, stomach, or intestines were observed in treated rat. At necropsy in the rats that died during the study or in those killed at the termination of the study. Therefore,LD50 was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally via gavage.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute oral toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 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:
- 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
- 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 of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals.
- Reason / purpose for cross-reference:
- read-across source
- 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 two acute dermal toxicity studies as-WoE- 2;3 and 4.
Acute Oral 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:
- other: 2. rat 3. rabbit 4.rabbit
- Strain:
- other: 2.Sprague-Dawley 3.not specified 4.not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 2.TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 8 – 12 weeks were used.
- Weight at study initiation: The weight range of approximately 212.7 to 250.8 grams at initiation of dosing.
Body weights at the start :
Male
Mean : 245.18 g (= 100 %)
Minimum : 236.8 g (- 3.42 %)
Maximum : 250.8 g (+ 2.29 %)
Total No. of animals : 5
Female
Mean : 218.66 g (= 100 %)
Minimum : 212.7 g (- 2.73 %)
Maximum : 222.2 g (+ 1.62 %)
Total No. of animals : 5
- Identification: Each rat was individually identified by the cage number.
- Fasting period before study: No data available
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 21.6 degree centigrade.
- Humidity (%): 55.0% to 58.4%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: 12-06-2017 to 27-06-2017 - Type of coverage:
- other: 2.semiocclusive 3. dermal 4.dermal
- Vehicle:
- other: 2.Distilled water 3.eyeshadow form
- Details on dermal exposure:
- 2.TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: Yes
3.DOSAGE PREPARATION (if unusual):Dose were applied 10 % in eyeshadow form. - Duration of exposure:
- 2.24 hours
3.not specified - Doses:
- 2.A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).
3.2000 mg/kg bw
4.5000mg/kg bw - No. of animals per sex per dose:
- 2.10 (5/sex).
3.10 - Control animals:
- not specified
- Details on study design:
- 2.- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observations and General Appearance:Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Evaluation of Dermal Reaction:Dermal reaction was observed daily for study period of 14 days.
Body weights:Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology:Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.
3.not specified - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- 2.
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- 3.
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- 4.
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- 2.Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.
3.no mortality was observed at dose 2000 mg/kg bw
4.No mortality was observed - Clinical signs:
- other: 2.Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result
- Gross pathology:
- 2.Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
3.not specified - Other findings:
- 2.- Other observations: Evaluation of Dermal Reaction
Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
3.not specified - Interpretation of results:
- other: not classified
- Conclusions:
- According to CLP regulation,the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.
- Executive summary:
Data available for the test chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical.The studies are as mentioned below:
The acute dermal toxicity profile of test chemical in Sprague Dawley rats according to OECD Guideline 402 (Acute Dermal Toxicity). The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. Thus, The LD50 value was considered to be >2000 mg/kg bw,when male and female Sprague Dawley rats were semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).
In a acute dermal toxicity study, 10 rabbits were treated with test chemical in the concentration 2000 mg/kg dermally as a 10 % in eye shadow form. No effect on survival of treated rabbits was observed to be 2000 mg/kg. Therefore, LD50 value was considered to be > 2000 mg/kg bw,when rabbits were treated with test chemical dermally as a 10 % in eye shadow form.
Moreover,Acute dermal toxicity study was done in rabbit using test chemical.No mortality was observed at dose 5000 mg/kg bw. Hence the LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.
Thus, based on the above summarised studies of test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute dermal toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from prediction report.
Additional information
Acute oral Toxicity:
Data available for the test chemical has been reviewed to determine the acute oral toxicity of the test chemical.The studies are as mentioned below:
In a acute oral toxicity study, rats were treated with test chemical orally. No mortality was observed in treated rats at 2500 mg/kg bw.Therefore, LD50 value was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally.
In another acute oral toxicity study, rat were treated with test chemical in the concentration of 2000 and 2500 mg/kg bw in olive oil orally. No mortality was observed in treated rat at 2000 and 2500 mg/kg bw. No lesions of the liver, spleen, stomach, or intestines were observed in treated rat. At necropsy in the rats that died during the study or in those killed at the termination of the study. Therefore,LD50 was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally via gavage.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute oral toxicity.
Acute Inhalation Toxicity:
Test chemical has very low vapour pressure (2.16E-09 Pa. = 1.620133003827e-11 mmHg),So the potential for the generation of inhalable vapours is very low. Also 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 and therefore the acute inhalation toxicity end point was considered for waiver.
Acute dermal Toxicity:
Data available for the test chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical.The studies are as mentioned below:
The acute dermal toxicity profile of test chemical in Sprague Dawley rats according to OECD Guideline 402 (Acute Dermal Toxicity). The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. Thus, The LD50 value was considered to be >2000 mg/kg bw,when male and female Sprague Dawley rats were semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).
In a acute dermal toxicity study, 10 rabbits were treated with test chemical in the concentration 2000 mg/kg dermally as a 10 % in eye shadow form. No effect on survival of treated rabbits was observed to be 2000 mg/kg. Therefore, LD50 value was considered to be > 2000 mg/kg bw,when rabbits were treated with test chemical dermally as a 10 % in eye shadow form.
Moreover,Acute dermal toxicity study was done in rabbit using test chemical.No mortality was observed at dose 5000 mg/kg bw. Hence the LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.
Thus, based on the above summarised studies of test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute dermal toxicity.
Justification for classification or non-classification
Based on the above experimental studies on Test chemical, it can be concluded that LD50 value is >2000 mg/kg bw for acute oral and dermal toxicity.Thus, comparing this value with the criteria of CLP regulation,Test chemical cannot be classified for acute oral and dermal toxicity. For Acute inhalation toxicity waiver was added so, not possible to classify.
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