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EC number: 244-034-6 | CAS number: 20780-49-8
- 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
Repeated dose toxicity: Oral
No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg body weight, when Sprague Dawley male and female rats were treated with the given test chemical via oral route, over a period of 90 days.
Repeated dose toxicity: Inhalation
A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 12.93 Pa (0.0900074 mmHg), 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 and therefore this end point for repeated inhalation toxicity was considered for waiver.
Repeated dose toxicity: Dermal
A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic 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:
- Weight of evidence approach 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 repeated dose toxicity studies i.e. WoE-2 and WoE-3.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- other: 2. water 3. not specified
- Details on oral exposure:
- 2. VEHICLE
- Concentration in vehicle: 100, 500, and 1000 mg/kg/day
- Amount of vehicle (if gavage): 1.111 ml/kg
3. No data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 Days
- Frequency of treatment:
- 2. daily, 5 days/week for 13 weeks
3. once/day, 5 days/wk - Remarks:
- 0, 100, 500, 1000 mg/kg bw/day
- No. of animals per sex per dose:
- 2. A group of 20 rats/sex/group
3. A group of 20 rats/sex/group - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- 2. CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes, all surviving animals were weighed.
- Time schedule for examinations: after 13 weeks
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes, blood samples were collected from the abdominal aortas.
- Time schedule for collection of blood: following an overnight fast
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: No data
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes, clinical laboratory studies (hematology and serum chemistry) were
Performed.
- Time schedule for collection of blood: after 45 days and at study termination.
- Animals fasted: No data
- How many animals: on 5
animals/sex/dose after 45 days (interim sacrifice), and all animals at study termination.
- Parameters checked in table [No.?] were examined.
3. CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes, all surviving animals were weighed.
- Time schedule for examinations: after 13 weeks
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes, blood samples were collected from the abdominal aortas.
- Time schedule for collection of blood: following an overnight fast
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: No data
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes, clinical laboratory studies (hematology and serum chemistry) were
Performed.
- Time schedule for collection of blood: after 45 days and at study termination.
- Animals fasted: No data
- How many animals: on 5
animals/sex/dose after 45 days (interim sacrifice), and all animals at study termination.
- Parameters checked in table [No.?] were examined. - Sacrifice and pathology:
- 2. GROSS PATHOLOGY: Yes, at 45 days, a complete necropsy was performed and livers were collected, weighed and reserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguination. Complete necropsies were performed.
HISTOPATHOLOGY: Yes, microscopic examination was performed.
3. GROSS PATHOLOGY: Yes, at 45 days, a complete necropsy was performed and livers were collected, weighed and reserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguination. Complete necropsies were performed.
HISTOPATHOLOGY: Yes, microscopic examination was performed - Other examinations:
- 2. No data
3. Clinical laboratory studies (hematology and serum chemistry) were performed pretest on 5 males and 5 females (non-study animals). - Statistics:
- No data
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 2. Rats produced minimal signs of systemic toxicity.
3. Rats produced minimal signs of systemic toxicity. The in-life clinical observations were primarily oral and dermal irritation (no clear dose response). - Mortality:
- no mortality observed
- Description (incidence):
- 2. There was no treatment-related mortality.
3. There was no treatment-related mortality. - Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 2. Weekly mean body weights were not significantly altered compared to controls.
3. Weekly mean body weights values were not significantly altered compared to controls. - Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- 2. Food consumption values were not significantly altered compared to controls.
3. Food consumption values were not significantly altered compared to controls. - Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 2. The qualitative hematologic data were unremarkable at all dose levels for the interim and terminal evaluations.
3. The qualitative hematologic data were unremarkable at all dose levels. At the terminal sacrifice, glucose values for the 500, and 1000 mg/kg/day males were lower than controls and the total protein values for the 100 mg/kg/day females were higher than controls. - Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- 2. At the terminal sacrifice, there were no biologically significant differences between treated and control animals for the measured clinical chemistries.
3. not specified - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 2. Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. All other organ weights were comparable to control values.
3. Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. - Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 2. Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy only in the high-dose male rats that were consistent with alpha-2u-globulin effects.
3. Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy in the mid- and high-dose male rats that were consistent with alpha-2uglobulin effects. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- 2. Histopathology review of all other tissues from high-dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix, and corpus of the uterus, and vagina), showed normal morphology.
3. Histopathology review of all other tissues from high dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix/corpus of the uterus, and vagina), showed normal morphology. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Remarks:
- 2
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- Dose descriptor:
- NOAEL
- Remarks:
- 3
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- Critical effects observed:
- not specified
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg body weight, when Sprague Dawley male and female rats were treated with the given test chemical via oral route, over a period of 90 days.
- Executive summary:
Data available from the various sources was reviewed to determine the toxic nature of the given test chemical. The studies are as mentioned below:
90 days repeated oral toxicity study was performed to determine the toxic nature of the given test chemical. The study was performed using male and female Sprague-Dawley rats at dose level of 0 (water) or 100, 500 or 1000 mg/kg/day. Controls received a dose of water volumetrically comparable to the dosage administered to the high dose group, 1.111 ml/kg. Clinical laboratory studies (hematology and serum chemistry) were performed pretest on 5 males and 5 females (non-study animals), on 5 animals/sex/ dose after 45 days (interim sacrifice), and all animals at study termination. Blood samples were collected from the abdominal aortas following an overnight fast. At 45 days, a complete necropsy was performed and livers were collected, weighed and preserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguinations. Complete necropsies were performed. Oral administration of the test chemical daily, 5 days/week for 13 weeks, to rats produced minimal signs of systemic toxicity. There was no treatment-related mortality. The in-life clinical observations were primarily oral and dermal irritation (no clear dose response). Weekly mean body weights and food consumption values were not significantly altered compared to controls. The qualitative hematologic data were unremarkable at all dose levels for the interim and terminal evaluations. At the terminal sacrifice, there were no biologically significant differences between treated and control animals for the measured clinical chemistries. Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. All other organ weights were comparable to control values. Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy only in the high-dose male rats that were consistent with alpha-2u-globulin effects. Histopathology review of all other tissues from high-dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix, and corpus of the uterus, and vagina), showed normal morphology. Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day, when male and female Sprague-Dawley rats were exposed to the given test chemical for 90 days.
In another study, 90 days repeated oral toxicity study was performed to determine the toxic nature of the given test chemical. The study was performed using male and female Sprague-Dawley rats at dose level of 0 (water) or 100, 500 or 1000 mg/kg/day. Controls received a dose of water volumetrically comparable to the dosage administered to the high dose group, 1.111 ml/kg. Clinical laboratory studies (hematology and serum chemistry) were performed pretest on 5 males and 5 females (non-study animals), on 5 animals/sex/dose after 45 days (interim sacrifice), and all animals at study termination. Blood samples were collected from the abdominal aortas following an overnight fast. At 45 days, a complete necropsy was performed and livers were collected, weighed and preserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguinations. Complete necropsies were performed. Oral administration of the given test chemical daily, 5 days/week for 13 weeks, to rats produced minimal signs of systemic toxicity. There was no treatment-related mortality. The in-life clinical observations were primarily oral and dermal irritation (no clear dose response). Weekly mean body weights and food consumption values were not significantly altered compared to controls. The qualitative hematologic data were unremarkable at all dose levels. At the terminal sacrifice, glucose values for the 500, and 1000 mg/kg/day males were lower than controls and the total protein values for the 100 mg/kg/day females were higher than controls. Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy in the mid- and high-dose male rats that were consistent with alpha-2uglobulin effects. Histopathology review of all other tissues from high dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix/corpus of the uterus, and vagina), showed normal morphology. Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day, when male and female Sprague-Dawley rats were exposed to the given test chemical for 90 days.
Thus based on the above studies, the No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg / kg body weight and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is Klimicsh 2 and from handbook or collection of data.
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Data available from the various sources was reviewed to determine the toxic nature of the given test chemical. The studies are as mentioned below:
90 days repeated oral toxicity study was performed to determine the toxic nature of the given test chemical. The study was performed using male and female Sprague-Dawley rats at dose level of 0 (water) or 100, 500 or 1000 mg/kg/day. Controls received a dose of water volumetrically comparable to the dosage administered to the high dose group, 1.111 ml/kg. Clinical laboratory studies (hematology and serum chemistry) were performed pretest on 5 males and 5 females (non-study animals), on 5 animals/sex/ dose after 45 days (interim sacrifice), and all animals at study termination. Blood samples were collected from the abdominal aortas following an overnight fast. At 45 days, a complete necropsy was performed and livers were collected, weighed and preserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguinations. Complete necropsies were performed. Oral administration of the test chemical daily, 5 days/week for 13 weeks, to rats produced minimal signs of systemic toxicity. There was no treatment-related mortality. The in-life clinical observations were primarily oral and dermal irritation (no clear dose response). Weekly mean body weights and food consumption values were not significantly altered compared to controls. The qualitative hematologic data were unremarkable at all dose levels for the interim and terminal evaluations. At the terminal sacrifice, there were no biologically significant differences between treated and control animals for the measured clinical chemistries. Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. All other organ weights were comparable to control values. Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy only in the high-dose male rats that were consistent with alpha-2u-globulin effects. Histopathology review of all other tissues from high-dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix, and corpus of the uterus, and vagina), showed normal morphology. Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day, when male and female Sprague-Dawley rats were exposed to the given test chemical for 90 days.
In another study, 90 days repeated oral toxicity study was performed to determine the toxic nature of the given test chemical. The study was performed using male and female Sprague-Dawley rats at dose level of 0 (water) or 100, 500 or 1000 mg/kg/day. Controls received a dose of water volumetrically comparable to the dosage administered to the high dose group, 1.111 ml/kg. Clinical laboratory studies (hematology and serum chemistry) were performed pretest on 5 males and 5 females (non-study animals), on 5 animals/sex/dose after 45 days (interim sacrifice), and all animals at study termination. Blood samples were collected from the abdominal aortas following an overnight fast. At 45 days, a complete necropsy was performed and livers were collected, weighed and preserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguinations. Complete necropsies were performed. Oral administration of the given test chemical daily, 5 days/week for 13 weeks, to rats produced minimal signs of systemic toxicity. There was no treatment-related mortality. The in-life clinical observations were primarily oral and dermal irritation (no clear dose response). Weekly mean body weights and food consumption values were not significantly altered compared to controls. The qualitative hematologic data were unremarkable at all dose levels. At the terminal sacrifice, glucose values for the 500, and 1000 mg/kg/day males were lower than controls and the total protein values for the 100 mg/kg/day females were higher than controls. Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy in the mid- and high-dose male rats that were consistent with alpha-2uglobulin effects. Histopathology review of all other tissues from high dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix/corpus of the uterus, and vagina), showed normal morphology. Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day, when male and female Sprague-Dawley rats were exposed to the given test chemical for 90 days.
Thus based on the above studies, the No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg / kg body weight and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Repeated dose toxicity: Inhalation
A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 12.93 Pa (0.0900074 mmHg), 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 and therefore this end point for repeated inhalation toxicity was considered for waiver.
Repeated dose toxicity: Dermal
A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Justification for classification or non-classification
Based on the data available and applying the weight of evidence approach, the given test chemical does not exhibit toxic nature upon repeated exposure by oral route of exposure. Hence, it is not likely to classify as toxic as per the criteria mentioned in CLP regulation. For repeated inhalation and repeated dermal toxicity wavier was added so, not possible to classify.
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