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EC number: 204-541-5 | CAS number: 122-40-7
- 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 oral dose toxicity study ofAmyl cinnamic aldehyde was studied in CFE strain rats. Doses of test substance administered orally in diet were6.1, 29.9 and 287.3 mg/kg/day for males and 6.7, 34.9 and 320.3 mg/kg/day for females. Test substance was fed to groups of 15 male rats (body weight loo-125 g) and15 females (body weight 90-120 g) for 14 wk.Additional groups of five rats were fed with 6.1, 29.9 and 287.3 mg/kg/day for males and 6.7, 34.9 and 320.3 mg/kg/day for females. Animals were fed on Spillers laboratory small animal diet. Water is provided to animals throughout study. Hematological screening, serum analysis and urine analysis were done. After appropriate period of feeding the rats were killed by exsanguination under barbiturates anesthesia. Gross pathology and histopathology investigation were done.Apart from three rats, no abnormalities were seen in behavior or appearance of animal. No mortality was reported in the study.Animals were weigh initially and then weekly thereafter. Increase in body weight at each dose level was reported. There were no statistically significant differences between treated and control groups in rate of body-weight gain. There were no statistically significant differences between treated and control groups in food consumption. The mean intakes of amyl cinnamic aldehyde over the 14wk period were 6.1, 29.9 and 287.3 mg/kg/day by the males of the groups given 4, 20 and 200 mg/kg bw of test substance in the diet and 6.7, 34.9 and 320.3 mg/kg/day by the females. There were no statistically significant differences between treated and control groups in water consumption. The mean water consummation over 14wk period were 25.8, 25.8 and 27.5 ml/rat/day by the males and female, mean water consummation values were 24.9, 24.5 and 25 respectively.There were no significant differences between treated and control groups in the results of the hematological examinations. Hematological examinations were done on blood samples collected at 2, 6 and 14 week of study. Hemoglobin, Packed cell volume, RBC, Reticulocytes and Leucocytes were examined.A measurement of urinary concentrating ability was made during the final week of treatment by measuring the specific gravity and volume of urine produced in a 6-hr period of water deprivation. At the same time, samples of the urine were examined for appearance, microscopic constituents and content of cells, glucose, ketones, bile salts and blood. At wk 6 and 13, urine was also collected from the rats over a 2-hr period following a water load of 25 ml/kg and between 16 and 20 hr after the water load. The only statistically significant differences in the absolute organ weights of treated and control rats were seen after treatment of 6 week. These consisted of lower stomach weights in the males given 287.3 mg/kg bw amyl cinnamic aldehyde and lower small intestine weights in the females given 320.3 mg/kg bw. In the latter case, the difference was not significant when the organ weights were expressed relative to body weights. Patchy lungs in three male rats (two at 6.1 mg/kg bw of test substance level and one control) and pale kidneys in some male rats in all groups including controls. Small mammary adenomas were found in two treated female rats. One female rat shows respiratory depression, on histopathological examination of tissue revealed pneumonia and an abscess of renal pelvis. Mammary adenomas were reported in two female rats. Vacuolation of some liver cells, protein casts in kidney tubules and sign of chronic lung infection. The incidence of these findings was low and was similar in both treated and control rats.One female rat shows respiratory depression, on histopathological examination of tissue revealed pneumonia and an abscess of renal pelvis. Mammary adenomas were reported in two female rats. Vacuolation of some liver cells, protein casts in kidney tubules and sign of chronic lung infection. The incidence of these findings was low and was similar in both treated and control rats. Therefore NOAEL were approximately 23 mg/kg bw in males and 36 mg/kg bw in females as per study.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Peer reviewed journal research article
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Short term toxicity potential of Amyl Cinnamic Aldehyde was studied in CFE strain rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Amyl cinnamic aldehyde
- Molecular formula (if other than submission substance): C14H18O
- Molecular weight (if other than submission substance): 202.2952 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): 3% - Species:
- rat
- Strain:
- other: CFE
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding colony
- Age at study initiation: No data
- Weight at study initiation: Male: 100-125 g, Female: 90-120 g
- Fasting period before study: No data
- Housing: Animals housed in cages in animal room maintained at 21±1 °C with relative humidity 50-60%.
- Diet (e.g. ad libitum): Spillers Laboratory small animal diet, ad. libitum.
- Water (e.g. ad libitum): Water, ad. libitum.
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±1 °C
- Humidity (%):50-60%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light):
No data
IN-LIFE DATES: From: To: No data - Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Spillers Laboratory small animal diet
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): 4-5 days
- Mixing appropriate amounts with (Type of food): Spillers Laboratory Small Animal Diet
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Concentration in vehicle: 0,6.1,29.9 and 287.3 mg/kg/day for males
0,6.7, 34.9 and 320.3 mg/kg/day for females
- 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:
- 14 weeks
- Frequency of treatment:
- Daily
- Remarks:
- 0,6.1,29.9 and 287.3 mg/kg/day for males (0, 80, 400, 4000 ppm )
- Remarks:
- 0,6.7, 34.9 and 320.3 mg/kg/day for females ((0, 80, 400, 4000 ppm )
- No. of animals per sex per dose:
- 15 male and 15 female/dose
Test control: 15 male and 15 female
Satellite Control: 5 male and 5 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. respiratory distress and weight loss were observed
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations:
Animals were weigh initially and then weekly up to 14 weeks.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes , The food consumption were measured over the 24-hr period
preceding each weighing.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: ml/rat/day at 0, 5, 9, 14 week
OPHTHALMOSCOPIC EXAMINATION: No
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 2, 6, 14 week
- Anesthetic used for blood collection: Yes (Barbiturates anesthesia)
- Animals fasted: No data
Parameters checked in table [No.?] were examined: Yes, The hematological investigations consisted of measurement of hemoglobin ,content, packed cell volume, and counts of erythrocytes, total leucocytes and
individual types of leucocytes. Reticulocytes were counted in the samples from control rats
and those fed the highest level of amyl Cinnamic aldehyde .
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 2, 6, 14 week
- Animals fasted: No data
- Parameters checked in table [No.?] were examined: Yes, Serum was analyzed for the content of urea, glucose, total protein and albumin and for the activities of glutamio oxalacetic and glutamic-pyruvic transaminases and of lactic dehydrogenase.
URINALYSIS: Yes
- Time schedule for collection of urine: 6,12 and Final week of treatment.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. Yes , the specific gravity and volume of urine produced in a 6-hr period
of water deprivation. At the same time, samples of the urine were examined for appearance,
microscopic constituents and content of cells, glucose, ketones, bile salts and blood. At wk 6
and 13, urine was also collected from the rats over a 2-hr period following a water load of
25 ml/kg and between 16 and 20 hr after the water load.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: organ weight; Organ stomach, small intestine and caecum were weighed.- Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes, the rats were killed by exsanguinations under barbiturate anesthesia. Samples of salivary gland, trachea, aorta, thymus, lymph nodes, urinary bladder, colon, rectum, pancreas, uterus, skeletal muscle were observed
HISTOPATHOLOGY: Yes , The tissue that appeared to be abnormal were fixed in 10 %
buffered formalin. Pa&En-wax sections of these tissues were stained with haematoxylin and
eosin for microscopic examination. - Statistics:
- No data
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No statistically significant change were observed at all dose group compare to control.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No statistically significant change were observed at all dose group compare to control.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- No statistically significant change were observed at all dose group compare to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- No statistically significant change were observed at all dose group compare to control.
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No statistically significant change were observed at all dose group compare to control.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No statistically significant change were observed at all dose group compare to control.
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No statistically significant change were observed at all dose group compare to control.
- 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):
- The only statistically significant differences in the absolute organ weights of treated and control rats were seen after treatment of 6 week. These consisted of lower stomach weights in the males given 287.3 mg/kg bw amyl cinnamic aldehyde and lower small intestine weights in the females given 320.3 mg/kg bw. In the latter case, the difference was not significant when the organ weights were expressed relative to body weights.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Patchy lungs in three male rats (two at 6.1 mg/kg bw of test substance level and one control) and pale kidneys in some male rats in all groups including controls. Small mammary adenomas were found in two treated female rats.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One female rat shows respiratory depression, on histopathological examination of tissue revealed pneumonia and an abscess of renal pelvis. Vacuolation of some liver cells, protein casts in kidney tubules and sign of chronic lung infection. The incidence of these findings was low and was similar in both treated and control rats.
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Mammary adenomas were reported in two female rats.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 23 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant change were observed on the clinical sign/food consumption,body weight, hematological examinations,clinical chemistry,urine analysis ,organ weight, gross pathology and histopathology
- Remarks on result:
- other: No significant change were observed on the clinical sign/food consumption,body weight, hematological examinations,clinical chemistry,urine analysis ,organ weight, gross pathology and histopathology
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 36 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant change were observed on the clinical sign/food consumption,body weight, hematological examinations,clinical chemistry,urine analysis ,organ weight, gross pathology and histopathology
- Remarks on result:
- other: No significant change were observed on the clinical sign/food consumption,body weight, hematological examinations,clinical chemistry,urine analysis ,organ weight, gross pathology and histopathology
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The repeated dose oral toxicity study of Amyl cinnamic aldehyde was studied in CFE strain rats by administering doses of test substance in diet for male 0,6.1,29.9 and 287.3 mg/kg/day and for female 0,6.7, 34.9 and 320.3 mg/kg/day .Therefore NOAEL were 23 mg/kg bw/day in males and 36 mg/kg bw/day in females as insited by study.
- Executive summary:
Repeated oral dose toxicity study ofAmyl cinnamic aldehyde was studied in CFE strain rats. Doses of test substance administered orally in diet were6.1, 29.9 and 287.3 mg/kg/day for males and 6.7, 34.9 and 320.3 mg/kg/day for females. Test substance was fed to groups of 15 male rats (body weight loo-125 g) and15 females (body weight 90-120 g) for 14 wk.Additional groups of five rats were fed with 6.1, 29.9 and 287.3 mg/kg/day for males and 6.7, 34.9 and 320.3 mg/kg/day for females. Animals were fed on Spillers laboratory small animal diet. Water is provided to animals throughout study. Hematological screening, serum analysis and urine analysis were done. After appropriate period of feeding the rats were killed by exsanguination under barbiturates anesthesia. Gross pathology and histopathology investigation were done.Apart from three rats, no abnormalities were seen in behavior or appearance of animal. No mortality was reported in the study.Animals were weigh initially and then weekly thereafter. Increase in body weight at each dose level was reported. There were no statistically significant differences between treated and control groups in rate of body-weight gain. There were no statistically significant differences between treated and control groups in food consumption. The mean intakes of amyl cinnamic aldehyde over the 14wk period were 6.1, 29.9 and 287.3 mg/kg/day by the males of the groups given 4, 20 and 200 mg/kg bw of test substance in the diet and 6.7, 34.9 and 320.3 mg/kg/day by the females. There were no statistically significant differences between treated and control groups in water consumption. The mean water consummation over 14wk period were 25.8, 25.8 and 27.5 ml/rat/day by the males and female, mean water consummation values were 24.9, 24.5 and 25 respectively.There were no significant differences between treated and control groups in the results of the hematological examinations. Hematological examinations were done on blood samples collected at 2, 6 and 14 week of study. Hemoglobin, Packed cell volume, RBC, Reticulocytes and Leucocytes were examined.A measurement of urinary concentrating ability was made during the final week of treatment by measuring the specific gravity and volume of urine produced in a 6-hr period of water deprivation. At the same time, samples of the urine were examined for appearance, microscopic constituents and content of cells, glucose, ketones, bile salts and blood. At wk 6 and 13, urine was also collected from the rats over a 2-hr period following a water load of 25 ml/kg and between 16 and 20 hr after the water load. The only statistically significant differences in the absolute organ weights of treated and control rats were seen after treatment of 6 week. These consisted of lower stomach weights in the males given 287.3 mg/kg bw amyl cinnamic aldehyde and lower small intestine weights in the females given 320.3 mg/kg bw. In the latter case, the difference was not significant when the organ weights were expressed relative to body weights. Patchy lungs in three male rats (two at 6.1 mg/kg bw of test substance level and one control) and pale kidneys in some male rats in all groups including controls. Small mammary adenomas were found in two treated female rats. One female rat shows respiratory depression, on histopathological examination of tissue revealed pneumonia and an abscess of renal pelvis. Mammary adenomas were reported in two female rats. Vacuolation of some liver cells, protein casts in kidney tubules and sign of chronic lung infection. The incidence of these findings was low and was similar in both treated and control rats.One female rat shows respiratory depression, on histopathological examination of tissue revealed pneumonia and an abscess of renal pelvis. Mammary adenomas were reported in two female rats. Vacuolation of some liver cells, protein casts in kidney tubules and sign of chronic lung infection. The incidence of these findings was low and was similar in both treated and control rats. Therefore NOAEL were approximately 23 mg/kg bw in males and 36 mg/kg bw in females as per study.
Reference
Table. Mean body weights and consumption of food and water for rats fed amyl cinnamic aldehyde at 0-200 mg/kg bw of the diet for 14 wk
Dietary level (ppm) |
Body Weight (g) at week |
Weight gain (g) at 14 week |
Food Consumption (g/rat/day) at Week |
Mean food consumption (g/rat/day) |
||||||
0 |
5 |
9 |
14 |
0 |
5 |
9 |
14 |
|||
Males |
|
|
|
|
|
|||||
0 |
113 |
352 |
435 |
494 |
381 |
17.1 |
22.1 |
22.7 |
19.9 |
22.1 |
80 |
118 |
356 |
449 |
509 |
391 |
16.9 |
25.9 |
23.7 |
20.5 |
22.3 |
400 |
114 |
353 |
440 |
502 |
388 |
15.0 |
23.4 |
23.5 |
20.7 |
21.8 |
4000 |
116 |
343 |
428 |
490 |
374 |
16.6 |
21.8 |
22.1 |
19.7 |
20.6 |
Female |
|
|
|
|
|
|||||
0 |
104 |
226 |
267 |
297 |
193 |
15.4 |
16.5 |
18.4 |
14.7 |
17.8 |
80 |
106 |
232 |
274 |
305 |
199 |
14.9 |
18.6 |
20.4 |
16.1 |
17.6 |
400 |
104 |
238 |
280 |
311 |
207 |
14.7 |
19.4 |
21.6 |
14.0 |
18.6 |
4000 |
104 |
225 |
264 |
292 |
188 |
14.3 |
17.3 |
19.3 |
15.1 |
16.4 |
Dietary level (ppm) |
Water Consumption (ml/rat/day) at wk |
Mean water consumption (ml/rat/day) |
|||
0 |
5 |
9 |
14 |
||
Males |
|||||
0 |
20.3 |
28.3 |
27.6 |
30.1 |
26.9 |
80 |
20.2 |
28.7 |
26.5 |
29.8 |
25.8 |
400 |
18.3 |
27.9 |
28.0 |
30.5 |
25.8 |
4000 |
20.1 |
27.7 |
28.1 |
29.3 |
27.5 |
Female |
|||||
0 |
20.9 |
23.7 |
23.3 |
23.5 |
23.0 |
80 |
22.6 |
27.0 |
27.2 |
27.5 |
24.9 |
400 |
21.6 |
27.0 |
27.4 |
24.5 |
24.5 |
4000 |
20.1 |
27.2 |
26.1 |
25.6 |
25.0 |
Table: Hematological values of rats fed 0-200 mg/kg bw amyl cinnamic aldehyde in the diet for 2, 6 or 14 wk
Sex and Dietary level (ppm) |
|
Leucocytes |
||||||||
No. of rats |
Hb (g/100 ml) |
PCV (%) |
RBC (106/mm3) |
Retics (% of RBS) |
Total (103/mm3) |
Differential (%)
|
||||
N |
E |
L |
M |
|||||||
Week 2 |
||||||||||
Male |
||||||||||
0 |
5 |
13 |
43 |
6.20 |
1.80 |
6.67 |
9 |
1 |
89 |
1 |
400 |
5 |
13.3 |
42 |
6.20 |
- |
5.16 |
7 |
0 |
91 |
2 |
4000 |
5 |
13.5 |
43 |
6.41 |
1.72 |
6.09 |
7 |
1 |
90 |
2 |
Female |
||||||||||
0 |
5 |
12.4 |
41 |
5.99 |
0.90 |
3.95 |
10 |
0 |
88 |
1 |
400 |
5 |
12.8 |
43 |
6.16 |
- |
3.89 |
9 |
1 |
88 |
2 |
4000 |
5 |
12.8 |
43 |
6.45 |
1.69 |
3.47 |
7 |
2 |
89 |
2 |
Week 6 |
||||||||||
Male |
||||||||||
0 |
5 |
14.1 |
44 |
6.81 |
0.64 |
7.52 |
13 |
1 |
84 |
2 |
400 |
5 |
14.3 |
45 |
7.13 |
- |
6.66 |
14 |
0 |
85 |
1 |
4000 |
5 |
13.9 |
45 |
6.94 |
0.93 |
6.19 |
12 |
1 |
86 |
1 |
|
|
|
|
|
|
|
|
|
|
|
Female |
||||||||||
0 |
5 |
13.4 |
43 |
6.16 |
1.06 |
4.33 |
18 |
2 |
79 |
1 |
400 |
5 |
13.3 |
42 |
6.14 |
- |
4.33 |
16 |
2 |
80 |
2 |
4000 |
5 |
13.6 |
43 |
6.18 |
1.46 |
2.93 |
13 |
2 |
83 |
2 |
Week 14 |
||||||||||
Male |
||||||||||
0 |
15 |
15.3 |
44 |
7.15 |
0.80 |
6.20 |
21 |
2 |
76 |
1 |
80 |
15 |
14.9 |
44 |
7.10 |
- |
6.46 |
15 |
2 |
82 |
1 |
400 |
15 |
15.1 |
44 |
7.00 |
- |
6.21 |
17 |
2 |
80 |
1 |
4000 |
15 |
15.1 |
44 |
7.32 |
0.49 |
6.55 |
14 |
1 |
84 |
1 |
Female |
||||||||||
0 |
15 |
14.4 |
43 |
6.58 |
0.69 |
3.55 |
16 |
2 |
81 |
1 |
80 |
15 |
14.6 |
44 |
6.70 |
- |
3.91 |
18 |
3 |
78 |
1 |
400 |
15 |
14.5 |
43 |
6.65 |
- |
3.34 |
12 |
2 |
85 |
1 |
4000 |
15 |
14.1 |
43 |
6.63 |
0.71 |
3.21 |
16 |
2 |
81 |
1 |
Hb = Haemoglobin PCV = Packed cell volume RBC = Red blood cells Reties = Reticulocytes N = Neutrophils E = Eosinophils L = Lymphocytes M= Monocytes
Table. Values of serum analyses for rats treated with 0-200 mg/kg bw amyl cinnamic aldehyde in the diet for 2, 6 or 14 Week
Sex and Dietary level (ppm) |
No. of rats |
GOT (IU) |
GPT (IU) |
LDH (IU) |
Glucose (mg/100 ml) |
Urea (mg/100 ml) |
Protein (g/100 ml) |
Albumin (g/100 ml) |
Week 2 |
||||||||
Male |
||||||||
0 |
5 |
46 |
6 |
897 |
- |
15 |
5.9 |
5.5 |
400 |
4 |
43 |
6 |
945 |
- |
13 |
5.8 |
5.4 |
4000 |
5 |
41 |
6 |
875 |
- |
16 |
5.8 |
5.5 |
Female |
||||||||
0 |
5 |
51 |
7 |
1169 |
105 |
17 |
- |
4.2 |
400 |
4 |
59 |
6 |
1280 |
115 |
17 |
- |
4.0 |
4000 |
5 |
52 |
7 |
971 |
113 |
16 |
- |
4.1 |
Week 6 |
||||||||
Male |
||||||||
0 |
5 |
56 |
8 |
974 |
81 |
18 |
7.1 |
3.5 |
400 |
5 |
52 |
7 |
1071 |
81 |
15 |
7.1 |
4.0 |
4000 |
5 |
57 |
12 |
988 |
70 |
18 |
7.4 |
3.6 |
Female |
||||||||
0 |
5 |
46 |
9 |
941 |
75 |
19 |
7.3 |
3.8 |
400 |
5 |
45 |
6 |
907 |
88 |
19 |
7.1 |
4.1 |
4000 |
4 |
46 |
7 |
897 |
50 |
20 |
7.3 |
4.2 |
Week 14 |
||||||||
Male |
||||||||
0 |
15 |
46 |
10 |
769 |
141 |
15 |
7.4 |
3.7 |
80 |
15 |
43 |
9 |
783 |
124 |
16 |
7.4 |
4.0 |
400 |
15 |
43 |
10 |
794 |
112 |
18 |
7.4 |
4.0 |
4000 |
15 |
46 |
9 |
811 |
121 |
19 |
7.4 |
4.1 |
Female |
||||||||
0 |
15 |
45 |
7 |
803 |
115 |
18 |
7.5 |
4.4 |
80 |
15 |
45 |
8 |
790 |
111 |
19 |
7.8 |
4.6 |
400 |
15 |
43 |
9 |
845 |
126 |
15 |
7.6 |
4.2 |
4000 |
15 |
44 |
7 |
860 |
120 |
15 |
7.6 |
4.2 |
Table. Mean value of renal concentration/ dilution tests and urinary cell excretion in rats fed amyl cinnamic aldehyde at 0-200 mg/kg bw amyl cinnamic aldehyde in the diet for 2, 6 or 14 week.
Sex and dietary level (ppm) |
No. of rats
|
Cell excretion (103/hr) |
Concentration test |
Dilution Test (2 hr)
|
||||
Specific gravity |
Volume (ml) |
Specific Gravity |
Volume (ml) |
|||||
0-6 hr |
16-20 hr |
0-6 hr |
16-20 hr |
|
|
|||
Week 2 |
||||||||
Male |
||||||||
0 |
5 |
5.4 |
1.062 |
- |
1.5 |
- |
- |
- |
400 |
5 |
4.8 |
1.061 |
- |
2.2 |
- |
- |
- |
4000 |
5 |
3.1 |
1.066 |
- |
1.2 |
- |
- |
- |
Female |
||||||||
0 |
5 |
3.7 |
1.057 |
- |
2.2 |
- |
- |
- |
400 |
5 |
2.5 |
1.062 |
- |
2.1 |
- |
- |
- |
4000 |
5 |
4.3 |
1.060 |
- |
1.6 |
- |
- |
- |
Week 6 |
||||||||
Male |
||||||||
0 |
5 |
3.7 |
1.049 |
1.068 |
2.3 |
0.7 |
1.010 |
7.2 |
400 |
5 |
4.0 |
1.054 |
1.076 |
2.9 |
0.9 |
1.012 |
5.5 |
4000 |
5 |
3.9 |
1.056 |
1.065 |
2.5 |
1.4 |
1.009 |
6.4 |
Female |
||||||||
0 |
5 |
2.6 |
1.049 |
1.072 |
1.4 |
0.8 |
1.010 |
3.2 |
400 |
5 |
2.8 |
1.037 |
1.075 |
1.6 |
0.6 |
1.007 |
3.6 |
4000 |
5 |
3.8 |
1.045 |
1.073 |
1.0 |
0.7 |
1.013 |
2.7 |
Week 14 |
||||||||
Male |
||||||||
0 |
12 |
3.2 |
1.060 |
1.072 |
1.9 |
1.0 |
1.011 |
6.7 |
80 |
12 |
3.6 |
1.056 |
1.067 |
1.7 |
1.5 |
1.012 |
6.0 |
400 |
12 |
3.2 |
1.062 |
1.067 |
1.4 |
1.4 |
1.014 |
5.5 |
4000 |
12 |
3.6 |
1.060 |
1.065 |
1.6 |
1.4 |
1.012 |
6.7 |
Female |
|
|
|
|
|
|
|
|
0 |
12 |
2.2 |
1.062 |
1.079 |
0.5 |
0.3 |
1.010 |
5.3 |
80 |
12 |
2.9 |
1.051 |
1.068 |
0.9 |
0.6 |
1.011 |
4.4 |
400 |
12 |
3.8 |
1.049 |
1.068 |
0.7 |
0.3 |
1.012 |
4.9 |
4000 |
12 |
4.1 |
1.051 |
1.063 |
1.2 |
1.1 |
1.008 |
5.3 |
Table: Relative organ weights of rats fed amyl cinnamic aldehyde at 0-200 mg/kg bw of the diet for 2, 6 or 14 weeks.
Sex and Dietary level (ppm) |
No. of rats |
Relative organ weights (g/100 g body weight) |
Terminal Body Weight (g) |
|||||||||||
Brain |
Heart |
Liver |
Spleen |
Kidney |
Stomach |
Small Intestine |
Caecum |
Adrenals+ |
Gonads ++ |
Pituitary + |
Thyroid + |
|||
Week 2 |
||||||||||||||
Male |
||||||||||||||
0 |
5 |
0.76 |
0.41 |
3.33 |
0.33 |
0.86 |
0.60 |
3.42 |
0.36 |
24.2 |
1.16 |
3.84 |
6.99 |
226 |
400 |
5 |
0.70 |
0.41 |
3.32 |
0.28 |
0.82 |
0.52 |
3.18 |
0.35 |
24.5 |
1.18 |
3.89 |
6.97 |
240 |
4000 |
5 |
0.75 |
0.40 |
3.73 |
0.30 |
0.87 |
0.55 |
3.21 |
0.34 |
25.1 |
1.21 |
4.02 |
8.02 |
229 |
Female |
||||||||||||||
0 |
5 |
0.94 |
0.43 |
3.40 |
0.34 |
0.84 |
0.58 |
3.45 |
0.36 |
38.1 |
51.9 |
5.82 |
9.35 |
169 |
400 |
5 |
1.00 |
0.44 |
3.47 |
0.34 |
0.87 |
0.58 |
3.37 |
0.37 |
37.7 |
55.1 |
6.33 |
8.76 |
163 |
4000 |
5 |
0.97 |
0.43 |
3.51 |
0.35 |
0.86 |
0.57 |
3.38 |
0.37 |
36.6 |
46.0 |
5.84 |
9.52 |
167 |
Week 6 |
||||||||||||||
Male |
||||||||||||||
0 |
5 |
0.51 |
0.34 |
2.77 |
0.25 |
0.69 |
0.44 |
1.80 |
0.24 |
18.6 |
1.00 |
3.40 |
4.68 |
372 |
400 |
5 |
0.51 |
0.35 |
2.80 |
0.24 |
0.71 |
0.39 |
1.91 |
0.23 |
16.9 |
0.94 |
3.56 |
5.43 |
369 |
4000 |
5 |
0.54 |
0.35 |
3.06 |
0.24 |
0.77 |
0.46 |
1.92 |
0.27 |
19.4 |
1.06 |
3.40 |
5.65 |
338 |
Female |
||||||||||||||
0 |
5 |
0.76 |
0.35 |
2.75 |
0.28 |
0.67 |
0.51 |
2.64 |
0.38 |
35.2 |
59.3 |
4.51 |
7.77 |
223 |
400 |
5 |
0.76 |
0.33 |
2.56 |
0.24 |
0.65 |
0.62 |
2.47 |
0.32 |
34.7 |
41.4 |
4.41 |
8.40 |
213 |
4000 |
5 |
0.76 |
0.34 |
2.87 |
0.28 |
0.70 |
0.54 |
2.31 |
0.39 |
36.7 |
47.7 |
4.66 |
8.80 |
217 |
Week 14 |
||||||||||||||
Male |
||||||||||||||
0 |
15 |
0.40 |
0.28 |
2.42 |
0.17 |
0.60 |
0.39 |
1.62 |
0.24 |
13.7 |
0.77 |
2.34 |
4.20 |
476 |
80 |
15 |
0.38 |
0.28 |
2.51 |
0.18 |
0.58 |
0.41 |
1.62 |
0.24 |
12.2 |
0.72 |
2.40 |
4.23 |
492 |
400 |
15 |
0.39 |
0.28 |
2.45 |
0.18 |
0.60 |
0.38 |
1.63 |
0.23 |
13.1 |
0.79 |
2.35 |
4.27 |
485 |
4000 |
15 |
0.40 |
0.27 |
2.66 |
0.17 |
0.64 |
0.38 |
1.67 |
0.25 |
13.5 |
0.79 |
2.44 |
4.48 |
467 |
Female |
||||||||||||||
0 |
15 |
0.64 |
0.32 |
2.20 |
0.22 |
0.58 |
0.49 |
2.20 |
0.33 |
24.7 |
45.0 |
4.73 |
7.07 |
280 |
80 |
15 |
0.61 |
0.31 |
2.20 |
0.23 |
0.58 |
0.49 |
2.25 |
0.32 |
25.3 |
39.3 |
4.31 |
7.26 |
289 |
400 |
15 |
0.61 |
0.33 |
2.25 |
0.22 |
0.60 |
0.48 |
2.17 |
0.32 |
26.0 |
44.7 |
4.77 |
6.60 |
291 |
4000 |
15 |
0.63 |
0.32 |
2.35 |
0.24 |
0.61 |
0.51 |
2.15 |
0.36 |
25.7 |
47.4 |
4.70 |
6.90 |
276 |
+ Weights of this organ are expressed in mg/100 g body weight.
++ Weights of female gonads are expressed in mg/100 g body weight.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 23 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from K2 publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose oral toxicity:
Various experimental studies were reviewed to determine the toxic nature of alpha-Amyl cinnamaldehyde (122-40-7) upon repeated exposure by oral route. The studies are as mentioned below:
Repeated oral dose toxicity study ofAmyl cinnamic aldehyde was studied in CFE strain rats. Doses of test substance administered orally in diet were6.1, 29.9 and 287.3 mg/kg/day for males and 6.7, 34.9 and 320.3 mg/kg/day for females. Test substance was fed to groups of 15 male rats (body weight loo-125 g) and15 females (body weight 90-120 g) for 14 wk.Additional groups of five rats were fed with 6.1, 29.9 and 287.3 mg/kg/day for males and 6.7, 34.9 and 320.3 mg/kg/day for females. Animals were fed on Spillers laboratory small animal diet. Water is provided to animals throughout study. Hematological screening, serum analysis and urine analysis were done. After appropriate period of feeding the rats were killed by exsanguination under barbiturates anesthesia. Gross pathology and histopathology investigation were done.Apart from three rats, no abnormalities were seen in behavior or appearance of animal. No mortality was reported in the study.Animals were weigh initially and then weekly thereafter. Increase in body weight at each dose level was reported. There were no statistically significant differences between treated and control groups in rate of body-weight gain. There were no statistically significant differences between treated and control groups in food consumption. The mean intakes of amyl cinnamic aldehyde over the 14wk period were 6.1, 29.9 and 287.3 mg/kg/day by the males of the groups given 4, 20 and 200 mg/kg bw of test substance in the diet and 6.7, 34.9 and 320.3 mg/kg/day by the females. There were no statistically significant differences between treated and control groups in water consumption. The mean water consummation over 14wk period were 25.8, 25.8 and 27.5 ml/rat/day by the males and female, mean water consummation values were 24.9, 24.5 and 25 respectively.There were no significant differences between treated and control groups in the results of the hematological examinations. Hematological examinations were done on blood samples collected at 2, 6 and 14 week of study. Hemoglobin, Packed cell volume, RBC, Reticulocytes and Leucocytes were examined.A measurement of urinary concentrating ability was made during the final week of treatment by measuring the specific gravity and volume of urine produced in a 6-hr period of water deprivation. At the same time, samples of the urine were examined for appearance, microscopic constituents and content of cells, glucose, ketones, bile salts and blood. At wk 6 and 13, urine was also collected from the rats over a 2-hr period following a water load of 25 ml/kg and between 16 and 20 hr after the water load. The only statistically significant differences in the absolute organ weights of treated and control rats were seen after treatment of 6 week. These consisted of lower stomach weights in the males given 287.3 mg/kg bw amyl cinnamic aldehyde and lower small intestine weights in the females given 320.3 mg/kg bw. In the latter case, the difference was not significant when the organ weights were expressed relative to body weights. Patchy lungs in three male rats (two at 6.1 mg/kg bw of test substance level and one control) and pale kidneys in some male rats in all groups including controls. Small mammary adenomas were found in two treated female rats. One female rat shows respiratory depression, on histopathological examination of tissue revealed pneumonia and an abscess of renal pelvis. Mammary adenomas were reported in two female rats. Vacuolation of some liver cells, protein casts in kidney tubules and sign of chronic lung infection. The incidence of these findings was low and was similar in both treated and control rats.One female rat shows respiratory depression, on histopathological examination of tissue revealed pneumonia and an abscess of renal pelvis. Mammary adenomas were reported in two female rats. Vacuolation of some liver cells, protein casts in kidney tubules and sign of chronic lung infection. The incidence of these findings was low and was similar in both treated and control rats. Therefore NOAEL were approximately 23 mg/kg bw in males and 36 mg/kg bw in females as per study.
The data available for the target chemical alpha-Amyl cinnamaldehyde (122-40-7)is insufficient to classify the chemical as toxic. Also the NOAEL value range can be close to 23 mg/kg bw in males and 36 mg/kg bw in females. Based on the observations made, alpha-Amyl cinnamaldehyde does not exhibit toxicity upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route. Further testing is required to clearly judge the test chemical as toxic upon repeated exposure.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria for the target substance, alpha-Amyl cinnamaldehyde does not exhibit toxicity upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route. Further testing is required to clearly judge the test chemical as toxic upon repeated exposure.
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