Registration Dossier
Registration Dossier
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EC number: 220-180-6 | CAS number: 2654-57-1
Toxicological information
Repeated dose toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- sub-chronic 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
- Remarks:
- Experimental data from various test chemicals
- Justification for type of information:
- Data for the target chemical is summarized based on data from various test chemicals
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- sub-chronic 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 peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subchronic repeated dose oral toxicity was performed to evaluate the toxic nature of the test chemical in rats
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- 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: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Feed
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose level of 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg)
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg)
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- Duration of treatment: 8 weeks
Duration of exposure: 7 weeks - Frequency of treatment:
- Daily
- Remarks:
- 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg)
- No. of animals per sex per dose:
- Total: 40 males and 40 females
0 mg/Kg: 5 males and 5 females
215 mg/Kg: 5 males and 5 females
316 mg/Kg: 5 males and 5 females
460 mg/Kg: 5 males and 5 females
680 mg/Kg: 5 males and 5 females
1000 mg/Kg: 5 males and 5 females
1470 mg/Kg: 5 males and 5 females
2160 mg/Kg: 5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice weekly
BODY WEIGHT: Yes
- Time schedule for examinations:No data available
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, twice weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations:No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: NO data
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all surviving rats were sacrificed by necropsy
HISTOPATHOLOGY: No data - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean body weight gain for males of the 4600 ppm dose group was 4% less than that of the control group. Female rats in the same dose group had a 4% increase in body weight gain when compared with the controls. At a dietary concentration of 6800 ppm, the mean body weight gain for males was 9% less than the controls; it was 1 % less for females of the 6800 ppm group when compared to the controls.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 316 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No observed Adverse Effect level (NOAEL) for the test chemical is considered to be 316 mg/Kg bw.
- Executive summary:
Subchronic repeated dose oral toxicity study was performed to determine toxic nature of the test chemical. The study was performed using 5 male and 5 female rats at dose level of 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg). The rats were given treated feed for 7 weeks and untreated feed for 1 week; controls were fed control diet for 8 weeks. Body weights and feed consumption for all rats were measured twice weekly, At the end of the study, all surviving rats were sacrificed for necropsy. The mean body weight gain for males of the 4600 ppm dose group was 4% less than that of the control group. Female rats in the same dose group had a 4% increase in body weight gain when compared with the controls. At a dietary concentration of 6800 ppm, the mean body weight gain for males was 9% less than the controls; it was 1 % less for females of the 6800 ppm group when compared to the controls. No deaths occurred in any dosed group. One female control rat died on study. Based on the observations made, the No observed Adverse Effect level (NOAEL) for the test chemical is considered to be 316 mg/Kg bw.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: Principle mentioned below
- Principles of method if other than guideline:
- A chronic toxicity study was conducted in Osborn-Mendel rats to evaluate the toxic effects of cinnamaldehyde.
- GLP compliance:
- not specified
- Limit test:
- yes
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: Weanling rats
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Animals were housed individually in wire cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimatization period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available - Route of administration:
- oral: feed
- Vehicle:
- other: Feed
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with (Type of food): Details not specified.
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 0, 1000, 2500 or 10000 ppm (0, 5, 125 or 500 mg/Kg bw)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 16 weeks
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
0, 10000, 2500 or 1000 ppm (0, 500, 125 or 5 mg/Kg bw)
Basis:
no data - No. of animals per sex per dose:
- Total: 80 animals
0 ppm: 10 males, 10 females
1000 ppm: 10 males, 10 females
2500 ppm: 10 males, 10 females
10000 ppm: 10 males, 10 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data available
- Rationale for animal assignment (if not random): No data available
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Weekly
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, weekly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At 3, 6, 12 and 22 months
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: On all animals included in the study.
- Parameters examined: White cell counts, red cell counts, haemoglobins and haematocrits.
CLINICAL CHEMISTRY: No data available
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters examined: No data available
URINALYSIS: No data available - Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters examined No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed.
HISTOPATHOLOGY: Yes
Liver, kidneys, spleen, heart, testes, abdominal and thoracic viscera, and one hind leg, for bone, bone marrow and muscle were preserved, embedded, sectioned and stained with haematoxylin-eosin prior to microscopic examination. - Statistics:
- No data available
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight hepatic cell swelling was noted and slight hyperkeratosis of squamous portion of the stomach at a dose of 500 mg/Kg bw
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Test material given through feed. No effects observed
- Critical effects observed:
- not specified
- Conclusions:
- The no observad adverse effect level (NOAEL) was considered to be 125 mg/kg when Osborne-Mendel rats were exposed to test chemicals for 16 weeks.
- Executive summary:
In a chronic toxicity oral study, test substance was evaluated in male and female Osborne-Mendel rats where the test chemical was administered by diet at concentration of 0, 1000, 2500 or 10000 ppm (0, 5, 125 or 500 mg/kg body weight). No effects were noted when the rats were exposed to 2500 ppm (125 mg/kg body weight) while treatment with 10000 ppm (500 mg/kg body weight) resulted in slight hepatic cell swelling and slight hyperkeratosis of squamous portion of the stomach. Therefore, the no observed adverse effect level (NOAEL) was considered to be 125 mg/kg body weight when test chemical were administered by diet to male and female Osborne-Mendel rats for 16 weeks.
Data source
Reference
- Reference Type:
- publication
- Title:
- WoE of repeated dose oral toxicity study for CAS no 2654-57-1
- Author:
- Sustainability Support Services (Europe) AB
- Year:
- 2 019
- Bibliographic source:
- WoE report, Sustainability Support Services (Europe) AB, 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- 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
- Limit test:
- no
Test material
- Reference substance name:
- 4-methyl-1-phenyl-3-pyrazolidone
- EC Number:
- 220-180-6
- EC Name:
- 4-methyl-1-phenyl-3-pyrazolidone
- Cas Number:
- 2654-57-1
- Molecular formula:
- C10H12N2O
- IUPAC Name:
- 4-Methyl-1-phenylpyrazolidin-3-one
- Details on test material:
- - Name of the test chemical: 4-methyl-1-phenyl-3-pyrazolidone
- Molecular formula: C10H12N2O
- Molecular weight: 176.218 g/mol
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: 2. not specified; 3. Osborne Mendel rats
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 2. No data
3. TEST ANIMALS
- Source: No data available
- Age at study initiation: Weanling rats
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Animals were housed individually in wire cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimatization period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Feed
- Details on oral exposure:
- 2. PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose level of 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg)
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg)
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data
3. PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with (Type of food): Details not specified.
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 0, 1000, 2500 or 10000 ppm (0, 5, 125 or 500 mg/Kg bw)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 2. Duration of treatment: 8 weeks
Duration of exposure: 7 weeks
3. 16 weeks - Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg) / 2
- Remarks:
- 0, 10000, 2500 or 1000 ppm (0, 500, 125 or 5 mg/Kg bw) / 3
- No. of animals per sex per dose:
- 2. Total: 40 males and 40 females
0 mg/Kg: 5 males and 5 females
215 mg/Kg: 5 males and 5 females
316 mg/Kg: 5 males and 5 females
460 mg/Kg: 5 males and 5 females
680 mg/Kg: 5 males and 5 females
1000 mg/Kg: 5 males and 5 females
1470 mg/Kg: 5 males and 5 females
2160 mg/Kg: 5 males and 5 females
3. Total: 80 animals
0 ppm: 10 males, 10 females
1000 ppm: 10 males, 10 females
2500 ppm: 10 males, 10 females
10000 ppm: 10 males, 10 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- 2. CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice weekly
BODY WEIGHT: Yes
- Time schedule for examinations:No data available
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, twice weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations:No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: NO data
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available
3. CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Weekly
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as gfood/kg body weight/day: Yes, weekly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At 3, 6, 12 and 22 months
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: On all animals included in the study.
- Parameters examined: White cell counts, red cell counts, haemoglobins and haematocrits.
CLINICAL CHEMISTRY: No data available
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters examined: No data available
URINALYSIS: No data available - Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters examined No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available - Sacrifice and pathology:
- 2. GROSS PATHOLOGY: Yes, all surviving rats were sacrificed by necropsy
HISTOPATHOLOGY: No data
3. GROSS PATHOLOGY: Yes, Tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed.
HISTOPATHOLOGY: Yes, Liver, kidneys, spleen, heart, testes, abdominal and thoracic viscera, and one hind leg, for bone, bone marrow and muscle were preserved, embedded, sectioned and stained with haematoxylin eosin prior to microscopic examination. - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean body weight gain for males of the 4600 ppm dose group was 4% less than that of the control group. Female rats in the same dose group had a 4% increase in body weight gain when compared with the controls. At a dietary concentration of 6800 ppm, the mean body weight gain for males was 9% less than the controls; it was 1 % less for females of the 6800 ppm group when compared to the controls.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 3. Slight hepatic cell swelling was noted and slight hyperkeratosis of squamous portion of the stomach at a dose of 500 mg/Kg bw
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- 2
- Effect level:
- 316 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects were noted at the mentioned dose level
- Dose descriptor:
- NOAEL
- Remarks:
- 3
- Effect level:
- 125 other: mg/Kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects were noted at the mentioned dose level
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No observed Adverse Effect level (NOAEL) for the test chemical is considered to be 316 mg/Kg bw.
- Executive summary:
Data available for the various test chemicals was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:
Subchronic repeated dose oral toxicity study was performed to determine toxic nature of the test chemical. The study was performed using 5 male and 5 female rats at dose level of 0, 2150, 3160, 4600, 6800, 10,000, 14,700 or 21,600 ppm (0, 215, 316, 460, 680, 1000, 1470 or 2160 mg/Kg). The rats were given treated feed for 7 weeks and untreated feed for 1 week; controls were fed control diet for 8 weeks. Body weights and feed consumption for all rats were measured twice weekly, At the end of the study, all surviving rats were sacrificed for necropsy. The mean body weight gain for males of the 4600 ppm dose group was 4% less than that of the control group. Female rats in the same dose group had a 4% increase in body weight gain when compared with the controls. At a dietary concentration of 6800 ppm, the mean body weight gain for males was 9% less than the controls; it was 1 % less for females of the 6800 ppm group when compared to the controls. No deaths occurred in any dosed group. One female control rat died on study. Based on the observations made, the No observed Adverse Effect level (NOAEL) for the test chemical is considered to be 316 mg/Kg bw.
In another study, Chronic toxicity oral study for the test compound cinnamic aldehyde was studied in male and female Osborne-Mendel rats. The test compound was fed through the diet at a concentration of 0, 100, 2500 or 10000 ppm (0, 5, 125 or 500 mg/Kg bw). No effects were noted on microscopic examination at 125 mg/KG bw. Slight hepatic cell swelling was noted and slight hyperkeratosis of squamous portion of the stomach at a dose level of 500 mg/Kg bw. The No observed Adverse Effect Level (NOAEL) for the test compound cinnamaic aldehyde in Osborne-
Mendel rats is found to be 125 mg/Kg bw.
Based on the observations made, the No observed Adverse Effect level (NOAEL) for the test chemical is considered to be 316 mg/Kg bw.
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