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EC number: 612-975-5 | CAS number: 6225-08-7
- 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
The repeated dose toxicity of the registration substance Genagen PA/N.N-Dimethylnonamide was evaluated according to the Guideline OECD 407.
Rats were treated for 28 days per gavage, the applied doses being 0, 100, 300 and 1000 mg/kg bw/day. The study included recovery animals that were treated at doses of 0 or 1000 mg/kg bw/day for 28 days and were allowed to recover for 14 days.
The observation parameters included clinical signs, body weight, food consumption, functional observation batteries, ophthalmoscopic examination, hematology, clinical chemistry, urine analysis, macroscopic pathology and histophathology.
No significant effect was found up to the highest dose of 1000 mg/kg bw. The NOAEL of 1000 mg/kg bw/day was obtained.
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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May 2017 to 8 Dec 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Repeated Dose 28-Day Oral Toxicity Study in Rodents” adopted on 3 October 2008
- Deviations:
- no
- Principles of method if other than guideline:
- The study included recovery animals.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 112-2016-11 D
- Expiration date of the batch: May 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)
- Solubility of the test substance in the vehicle: miscible with corn oil
FORM AS APPLIED IN THE TEST: Liquid - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- Rat is one of the recommended species by regulatory agencies for conducting preclinical toxicological studies among rodent species
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 weeks; The dosing was initiated not later than 8 weeks of age
- Housing: In a standard polypropylene cage (size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet - Pellet (Manufactured by Envigo)
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in aquaguard water filter cum purifier
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7°C to 23.9°C
- Humidity (%): 46 to 69%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle - Route of administration:
- oral: gavage
- Details on route of administration:
- The test item was administered through oral route using stainless steel gavage cannula as it is the probable route in humans
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle: Corn oil was used as vehicle for the preparation of formulations as the test item is miscible with corn oil as evidenced by the in-house solubility/ suspendibility test results
- Concentration in vehicle: G1: 0 mg/mL
G2: 100 mg/mL
G3: 300 mg/mL
G4: 1000 mg/mL - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The dose samples were taken in duplicates sets (5 mL for each set from top, middle and bottom layers) during week 1 and week 4 and were analyzed for dose concentration by the validated GC-FID system. The results were found to be within the acceptable range of 85 to 115% to the nominal concentration and less than 10.0% RSD.
- Duration of treatment / exposure:
- 28 consecutive days
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Vehicle Control
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Remarks:
- Low dose
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Remarks:
- Mid dose
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- High dose
- No. of animals per sex per dose:
- 5 males and 5 females for the dose levels of 0, 100, 300 and 1000 mg/kg bw.
5 males and 5 females for the dose levels of 0 and 1000 mg/kg bw for the recovery groups. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Doses selected for the study were 100, 300 and 1000 mg/kg body weight as low, mid and high doses respectively. The control animals were dosed with vehicle alone. This dose levels were selected based on the results of 14-day dose-range finding study (BIO-TX 2075). There were no clinical signs or mortality were observed up to the dose of 1000 mg/kg bw. Hence, in this study, dose levels of 100, 300 and 1000 mg/kg body weight were selected- Dose selection rationale:
- Rationale for animal assignment (if not random):
- Rationale for selecting satellite groups:
- Post-exposure recovery period in satellite groups:
- Section schedule rationale (if not random): - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS:
All animals were observed once daily for clinical signs of toxicity and twice daily for mortality and morbidity.
DETAILED CLINICAL OBSERVATIONS:
The animals were subjected to detailed clinical examinations before initiation of the treatment and at weekly intervals thereafter during the experiment. These observations were made outside the home cage and preferably at the same time on the day of examination. Signs noted included, but not limited to, changes in skin, fur, eyes and mucous membranes, occurrence of secretions and excretions autonomic activity such as lacrimation, piloerection, pupil size and unusual respiratory pattern.
BODY WEIGHT:
Individual animal body weights were recorded on the Day 1, before test item administration and at weekly intervals thereafter. Fasting body weight of all the animals was recorded at terminal sacrifice.
FOOD CONSUMPTION
Individual animal food consumption was recorded weekly, coinciding with the body weights of the respective animals. Food intake per rat (g/rat/day) was calculated using the amount of food given and left over in each cage and the number of rats in each cage.
OPHTHALMOSCOPIC EXAMINATION:
Ophthalmoscopic examination was performed for all the animals before start of the treatment and during week 4 of treatment for G1 and G4 group animals and during week 6 for recovery group animals. As the results of examinations during week 4 did not reveal any treatment related occular changes, the examination was not extended to lower main dose groups.
HAEMATOLOGY AND CLINICAL CHEMISTRY:
Blood samples were collected from all the rats of main groups on day 29 and from recovery group animals on day 43. The animals were fasted overnight before blood collection. Water was provided ad libitum during fasting period. Blood samples were collected from the animals separately into the tubes containing K2-EDTA and lithium heparin tubes for hematology and clinical chemistry respectively, Sodium citrate tubes for Prothrombin time and activated partial thromboplastin time parameters. Blood samples were collected from retro-orbital plexus puncture under mild isoflurane anaesthesia with the help of a fine capillary tube.
URINALYSIS: Yes / No / Not specified
Urine was collected from all rats of main group animals and recovery group animals on day 29 and 43 respectively. The animals were kept in urine collection cages for overnight and were fasted but water was provided ad libitum during this period. The overnight urine volume (mL) collected from these animals was measured. The urine was analyzed using “Urine analyzer” DIRUI H-500” (Dirui Industrial Company Ltd.) and analyzed for blood, bilirubin, urobilinogen, ketones, protein, glucose and leucocytes.
The volume of urine collected (mL), appearance and the color were recorded by physical evaluation.
In addition pH, nitrite and specific gravity were also analyzed. After analysis of the above parameters, the urine was subjected for centrifugation at 1500 rpm for 3 minutes. Then the urine was subjected for microscopic examination for urine sediments.
NEUROBEHAVIOURAL EXAMINATION: Yes / No / Not specified
Neurological/Functional examination was carried out during week 4 for control and high dose main group animals and during last week for recovery group animals. As there were no treatment related effects, the examination was not carried out for lower dose groups. - Sacrifice and pathology:
- GROSS PATHOLOGY:
At the end of treatment (main groups) and recovery period (recovery groups), all animals were fasted overnight (water allowed) and on the day of necropsy (day 29 for main groups, day 43 for recovery groups), all animals were weighed and then subjected to necropsy. The animals were euthanized by using excess CO2 anaesthesia followed by exsanguination. The gross pathological examination was carried out for each rat. Necropsy included an examination of external surfaces, external orifices, abdominal, thoracic and cranial cavities, organs and tissues. The animals were sacrificed in a serial block sequence and complete gross pathological examination was performed.
HISTOPATHOLOGY:
Histopathological examination was conducted on the tissues from the vehicle control and high dose sacrificed at termination. All organs and tissue samples as defined in the study plan were processed, embedded in paraffin, cut at a thickness of 4 to 5 micrometers and stained with hematoxylin and eosin. The bone marrow smear was fixed in methanol and stained with Giemsa Stain.
The examination was not extended to the lower dose groups and recovery groups as there were no treatment related effects noted at the high dose. - Statistics:
- The raw data was subjected to statistical analysis. The computer printout of the data (in the form of appendix) was verified with the original raw data. After verification, the data was subjected to statistical analyses using SPSS software version 22. Body weight, percent change in body weight, feed consumption, organ weights and ratios, hematological and clinical chemistry estimations and urine analysis parameters (pH, specific gravity and urobilinogen) were subjected to statistical analysis. One way ANOVA followed by Dunnett’s post test was done for different treatment groups comparing with the control group data. Comparison of means between the recovery groups was done using ‘t’ test based on the requirement. All analysis and comparisons were evaluated at the 95% level of confidence (P<0.05).
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The values obtained for high dose animals towards end ot the treatment were reduced for females sacrificd at the termination of the treatment. However, oppositive tendency was found for females sacrificed after recovery period. This finding was considered to be incidental.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Urinalysis findings:
- effects observed, non-treatment-related
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Not applicable
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect found up to the highese dose of 1000 mg/kg bw/day
- Key result
- Critical effects observed:
- no
- Conclusions:
- The repeated dose toxicity of the registration substance Genagen PA/N.N-Dimethylnonamide was evaluated according to the Guideline OECD 407. No significant effect was found up to the highest dose of 1000 mg/kg bw. The NOAEL of 1000 mg/kg bw/day was obtained.
- Executive summary:
The repeated dose toxicity of the registration substance Genagen PA/N.N-Dimethylnonamide was evaluated according to the Guideline OECD 407.
Rats were treated for 28 days per gavage, the applied doses being 0, 100, 300 and 1000 mg/kg bw/day. The study included recovery animals that were treated at doses of 0 or 1000 mg/kg bw/day for 28 days and were allowed to recover for 14 days.
The observation parameters included clinical signs, body weight, food consumption, functional observation batteries, ophthalmoscopic examination, hematology, clinical chemistry, urine analysis, macroscopic pathology and histophathology.
No significant effect was found up to the highest dose of 1000 mg/kg bw. The NOAEL of 1000 mg/kg bw/day was obtained.
Reference
Table 1-1:SUMMARY OF MAEL BODY WEIGHTS (g)
Dose (mg/kg body weight/day) |
Days |
|||||||
1 |
8 |
15 |
22 |
28 |
36 |
42 |
||
Animals sacrificed on day 29 |
||||||||
0 |
Mean |
148.73 |
189.19 |
229.37 |
268.41 |
286.09 |
|
|
±SD |
15.02 |
22.45 |
28.51 |
37.14 |
40.33 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
100 |
Mean |
147.62 |
186.97 |
226.20 |
262.88 |
285.75 |
|
|
±SD |
14.06 |
14.01 |
16.90 |
18.48 |
23.39 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
300 |
Mean |
149.43 |
181.02 |
223.26 |
262.20 |
287.66 |
|
|
±SD |
11.71 |
18.86 |
23.00 |
24.23 |
25.73 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
1000 |
Mean |
150.63 |
182.30 |
222.18 |
256.17 |
271.66 |
|
|
±SD |
12.30 |
17.51 |
19.93 |
16.21 |
19.35 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
Animals sacrificed on day 43 (recovery animals) |
||||||||
0 |
Mean |
150.60 |
188.38 |
230.55 |
260.49 |
289.73 |
320.41 |
346.68 |
±SD |
5.62 |
11.02 |
17.47 |
18.63 |
21.04 |
20.89 |
19.80 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
148.93 |
180.65 |
220.21 |
248.55 |
276.29 |
305.82 |
323.82 |
±SD |
10.36 |
12.57 |
22.94 |
29.23 |
32.64 |
37.18 |
41.23 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; SD: Standard Deviation; n: Number of animals
Table 1 -2:SUMMARY OF FEMAEL BODY WEIGHTS (g)
Dose (mg/kg body weight/day) |
Days |
|||||||
1 |
8 |
15 |
22 |
28 |
36 |
42 |
||
Animals sacrificed on day 29 |
||||||||
0 |
Mean |
138.98 |
165.33 |
191.89 |
215.17 |
222.24 |
|
|
±SD |
9.29 |
10.52 |
12.11 |
13.48 |
10.94 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
100 |
Mean |
135.93 |
157.98 |
180.40 |
197.95 |
208.89 |
|
|
±SD |
12.10 |
13.77 |
16.53 |
15.43 |
20.30 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
300 |
Mean |
136.63 |
151.88 |
173.78 |
184.36* |
200.89 |
|
|
±SD |
8.28 |
14.36 |
16.70 |
12.24 |
18.93 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
1000 |
Mean |
139.20 |
154.15 |
170.29 |
187.34* |
196.61 |
|
|
±SD |
6.41 |
7.82 |
8.66 |
14.87 |
18.36 |
|
|
|
n |
5 |
5 |
5 |
5 |
5 |
|
|
|
Animals sacrificed on day 43 (recovery animals) |
||||||||
0 |
Mean |
139.61 |
162.33 |
187.15 |
206.54 |
217.44 |
235.08 |
247.34 |
±SD |
5.51 |
8.33 |
13.09 |
15.60 |
14.86 |
16.57 |
18.37 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
139.52 |
167.56 |
196.34 |
218.90 |
234.41 |
254.69 |
266.41 |
±SD |
4.11 |
5.83 |
7.30 |
8.09 |
7.75 |
11.97 |
12.86 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; SD: Standard Deviation; n: Number of animals
Table 2-1: SUMMARY OF HAEMATOLOGY RECORDFOR MALES
Dose (mg/kg body weight/day) |
Total Leucocyte Count (WBC) (103cells/µL) |
Total Erythrocyte Count (RBC) (106cells/µL) |
Hemoglobin (HGB) (g/dL) |
Haematocrit (HCT) (%) |
Mean Corpuscular Volume (MCV) (fL) |
Mean Corpuscular Hemoglobin (MCH) (pg) |
Mean Corpuscular Haemoglobin Concentration (MCHC) (g/dL) |
Platelet Count (PLT) (103cells/µL) |
Mean Platelet Volume (MPV) (fL) |
||
Animals sacrificed on day 29 |
|||||||||||
0 |
Mean |
11.24 |
7.24 |
12.98 |
41.82 |
57.82 |
17.96 |
31.04 |
810.60 |
5.68 |
|
±SD |
1.71 |
0.36 |
0.19 |
1.03 |
1.75 |
0.69 |
0.42 |
78.30 |
0.19 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
100 |
Mean |
10.12 |
6.97 |
12.74 |
40.26 |
57.74 |
18.30 |
31.70 |
836.20 |
5.72 |
|
±SD |
2.42 |
0.12 |
0.34 |
1.30 |
1.58 |
0.49 |
0.55 |
46.83 |
0.22 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
300 |
Mean |
11.06 |
7.01 |
12.74 |
40.06 |
57.20 |
18.20 |
31.82* |
781.60 |
5.96 |
|
±SD |
3.99 |
0.46 |
0.72 |
2.17 |
1.18 |
0.45 |
0.22 |
91.29 |
0.35 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
1000 |
Mean |
11.31 |
7.46 |
13.44 |
42.40 |
56.82 |
17.98 |
31.66 |
885.20 |
6.08 |
|
±SD |
2.81 |
0.28 |
0.74 |
1.61 |
0.54 |
0.44 |
0.58 |
191.70 |
0.28 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
Animals sacrificed on day 43 (recovery animals) |
|||||||||||
0 |
Mean |
9.54 |
7.37 |
13.58 |
41.40 |
56.16 |
18.40 |
32.82 |
910.80 |
6.36 |
|
±SD |
1.15 |
0.28 |
0.58 |
1.66 |
1.13 |
0.67 |
0.66 |
89.66 |
0.17 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
1000 |
Mean |
7.52 |
7.53 |
13.70 |
42.34 |
56.24 |
18.20 |
32.38 |
800.60 |
6.38 |
|
±SD |
1.92 |
0.36 |
0.49 |
1.83 |
1.07 |
0.56 |
0.60 |
92.08 |
0.18 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals
*. The mean difference is significant at the 0.05 level.
Table 2-2: SUMMARY OF HAEMATOLOGY RECORD FOR MALES
Dose (mg/kg body weight/day) |
Absolute Reticulocyte Count (109cells/L) |
Absolute Neutrophils (103cells/µL) |
Absolute Lymphocytes (103cells/µL) |
Absolute Monocytes (103cells/µL) |
Absolute Eosinophils (103cells/µL) |
Absolute Basophils (103cells/µL) |
Prothrombin Time (Seconds) |
Activated Prothrombin Time (Seconds) |
|||
Animals sacrificed on day 29 |
|||||||||||
0 |
Mean |
159.90 |
2.24 |
8.33 |
0.41 |
0.07 |
0.02 |
16.82 |
17.18 |
|
|
±SD |
25.09 |
0.60 |
1.54 |
0.16 |
0.03 |
0.01 |
0.54 |
1.30 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
100 |
Mean |
150.40 |
1.77 |
7.75 |
0.34 |
0.07 |
0.03 |
16.14 |
16.20 |
|
|
±SD |
36.29 |
0.29 |
2.03 |
0.14 |
0.02 |
0.01 |
0.81 |
1.47 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
300 |
Mean |
149.82 |
1.63 |
8.69 |
0.49 |
0.04 |
0.03 |
14.12* |
17.20 |
|
|
±SD |
31.36 |
0.73 |
3.69 |
0.17 |
0.01 |
0.01 |
0.89 |
1.94 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
1000 |
Mean |
111.90 |
1.61 |
8.77 |
0.58 |
0.13 |
0.03 |
15.92 |
18.48 |
|
|
±SD |
23.75 |
0.21 |
2.54 |
0.23 |
0.16 |
0.02 |
1.94 |
2.92 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
Animals sacrificed on day 43 (recovery animals) |
|||||||||||
0 |
Mean |
137.54 |
1.67 |
7.42 |
0.24 |
0.06 |
0.01 |
19.60 |
23.70 |
|
|
±SD |
31.22 |
0.65 |
1.48 |
0.05 |
0.01 |
0.01 |
4.31 |
9.83 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
1000 |
Mean |
114.44 |
1.42 |
5.64 |
0.28 |
0.05 |
0.01 |
17.36 |
32.60 |
|
|
±SD |
32.77 |
0.39 |
1.50 |
0.12 |
0.02 |
0.01 |
0.80 |
9.24 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
SD: Standard Deviation; n: number of animals
*. The mean difference is significant at the 0.05 level.
Table 2 -3: SUMMARY OF HAEMATOLOGY RECORDFOR FEMALES
Dose (mg/kg body weight/day) |
Total Leucocyte Count (WBC) (103cells/µL) |
Total Erythrocyte Count (RBC) (106cells/µL) |
Hemoglobin (HGB) (g/dL) |
Haematocrit (HCT) (%) |
Mean Corpuscular Volume (MCV) (fL) |
Mean Corpuscular Hemoglobin (MCH) (pg) |
Mean Corpuscular Haemoglobin Concentration (MCHC) (g/dL) |
Platelet Count (PLT) (103cells/µL) |
Mean Platelet Volume (MPV) (fL) |
||
Animals sacrificed on day 29 |
|||||||||||
0 |
Mean |
7.51 |
6.96 |
12.58 |
38.60 |
55.42 |
18.10 |
32.68 |
895.00 |
5.94 |
|
±SD |
0.74 |
0.26 |
0.29 |
1.29 |
1.14 |
0.56 |
0.50 |
62.05 |
0.36 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
100 |
Mean |
9.84 |
7.37 |
13.30 |
41.62 |
56.48 |
18.08 |
31.98 |
887.80 |
6.36 |
|
±SD |
0.94 |
0.43 |
0.56 |
2.20 |
1.47 |
0.65 |
0.55 |
99.61 |
0.19 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
300 |
Mean |
9.17 |
7.20 |
12.72 |
40.04 |
55.62 |
17.66 |
31.80* |
843.80 |
6.70* |
|
±SD |
2.85 |
0.41 |
0.90 |
2.66 |
1.34 |
0.54 |
0.32 |
375.79 |
0.72 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
1000 |
Mean |
8.82 |
7.47 |
13.44 |
42.08* |
56.28 |
17.98 |
31.94 |
937.80 |
6.26 |
|
±SD |
1.73 |
0.33 |
0.74 |
1.99 |
0.86 |
0.41 |
0.50 |
36.70 |
0.15 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
Animals sacrificed on day 43 (recovery animals) |
|||||||||||
0 |
Mean |
8.80 |
7.33 |
13.34 |
40.16 |
54.78 |
18.18 |
33.20 |
1028.20 |
6.48 |
|
±SD |
1.12 |
0.43 |
0.81 |
2.82 |
1.06 |
0.33 |
0.51 |
163.39 |
0.33 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
1000 |
Mean |
8.13 |
7.07 |
13.34 |
39.54 |
55.98 |
18.88 |
33.70 |
930.20 |
6.44 |
|
±SD |
0.64 |
0.17 |
0.59 |
1.59 |
1.54 |
0.59 |
0.31 |
223.14 |
0.09 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals
*. The mean difference is significant at the 0.05 level.
Table 2 -4: SUMMARY OF HAEMATOLOGY RECORDFOR FEMALES
Dose (mg/kg body weight/day) |
Absolute Reticulocyte Count (109cells/L) |
Absolute Neutrophils (103cells/µL) |
Absolute Lymphocytes (103cells/µL) |
Absolute Monocytes (103cells/µL) |
Absolute Eosinophils (103cells/µL) |
Absolute Basophils (103cells/µL) |
Prothrombin Time (Seconds) |
Activated Prothrombin Time (Seconds) |
|||
Animals sacrificed on day 29 |
|||||||||||
0 |
Mean |
90.22 |
1.51 |
5.49 |
0.28 |
0.10 |
0.01 |
13.40 |
20.26 |
|
|
±SD |
25.34 |
0.39 |
0.31 |
0.05 |
0.06 |
0.00 |
0.70 |
3.04 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
100 |
Mean |
92.70 |
2.06 |
7.21 |
0.34 |
0.09 |
0.02 |
13.56 |
18.72 |
|
|
±SD |
5.06 |
0.83 |
0.60 |
0.11 |
0.04 |
0.00 |
0.25 |
4.25 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
300 |
Mean |
129.14* |
1.81 |
6.84 |
0.31 |
0.10 |
0.02 |
14.12 |
17.78 |
|
|
±SD |
21.95 |
0.48 |
2.46 |
0.12 |
0.08 |
0.01 |
1.34 |
2.75 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
1000 |
Mean |
111.18 |
1.60 |
6.76 |
0.27 |
0.06 |
0.01 |
15.80* |
16.02 |
|
|
±SD |
21.84 |
0.69 |
1.35 |
0.11 |
0.02 |
0.01 |
1.01 |
3.32 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
Animals sacrificed on day 43 (recovery animals) |
|||||||||||
0 |
Mean |
112.42 |
1.31 |
7.04 |
0.24 |
0.09 |
0.02 |
16.26 |
28.20 |
|
|
±SD |
39.08 |
0.30 |
0.79 |
0.11 |
0.02 |
0.01 |
1.28 |
10.18 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
||
1000 |
Mean |
96.46 |
1.59 |
5.98* |
0.32 |
0.13 |
0.01 |
17.56 |
32.50 |
|
|
±SD |
15.54 |
0.29 |
0.42 |
0.04 |
0.05 |
0.00 |
1.55 |
12.87 |
|
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
SD: Standard Deviation; n: number of animals
*. The mean difference is significant at the 0.05 level.
Table 3-1: SUMMARY OF CLINICAL CHEMISTRY RECORDFOR MALES
Dose (mg/kg body weight/day) |
Glucose |
Urea |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
Alanine aminotransferase |
Aspartate aminotransferase |
Alkaline phosphatase |
Calcium |
|
(GLU) |
|
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
(ALT) |
(AST) |
(ALP) |
(CAL) |
||
mg/dL |
mg/dL |
mg/dL |
mg/dL |
mg/dL |
g/dL |
g/dL |
U/L |
U/L |
U/L |
mg/dL |
||
Animals sacrificed on day 29 |
||||||||||||
0 |
Mean |
103.20 |
22.36 |
0.51 |
62.60 |
80.60 |
6.80 |
3.29 |
66.20 |
120.60 |
428.20 |
10.38 |
±SD |
13.48 |
4.01 |
0.03 |
12.62 |
26.88 |
0.28 |
0.18 |
11.84 |
22.70 |
80.00 |
0.44 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
100 |
Mean |
98.20 |
13.96* |
0.49 |
71.80 |
95.80 |
6.46 |
3.24 |
64.20 |
115.20 |
401.20 |
10.12 |
±SD |
6.38 |
4.40 |
0.03 |
14.91 |
30.15 |
0.17 |
0.07 |
22.07 |
28.27 |
56.25 |
0.28 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
300 |
Mean |
104.00 |
14.90* |
0.47 |
66.00 |
77.20 |
6.56 |
3.28 |
58.60 |
109.00 |
429.40 |
9.78 |
±SD |
10.75 |
3.53 |
0.05 |
7.07 |
32.43 |
0.18 |
0.18 |
7.50 |
6.44 |
112.97 |
0.33 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
108.00 |
13.82* |
0.47 |
78.60 |
70.60 |
6.76 |
3.40 |
70.20 |
110.80 |
433.00 |
10.18 |
±SD |
11.47 |
3.02 |
0.04 |
11.55 |
8.88 |
0.23 |
0.08 |
6.22 |
8.58 |
66.85 |
0.41 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Animals sacrificed on day 43 (recovery animals) |
||||||||||||
0 |
Mean |
96.40 |
18.92 |
0.51 |
47.60 |
62.40 |
6.46 |
3.05 |
47.80 |
85.20 |
171.40 |
8.86 |
±SD |
10.29 |
4.60 |
0.04 |
11.17 |
23.92 |
0.13 |
0.13 |
3.56 |
6.18 |
31.28 |
0.18 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
96.40 |
20.66 |
0.54 |
49.20 |
55.80 |
6.54 |
3.13 |
51.60 |
90.40 |
178.80 |
8.78 |
±SD |
9.21 |
6.11 |
0.02 |
8.58 |
14.04 |
0.32 |
0.14 |
9.76 |
6.19 |
39.80 |
0.22 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals; *. The mean difference is significant at the 0.05 level.
Table 3-2: SUMMARY OF CLINICAL CHEMISTRY RECORD FOR MALES
Dose (mg/kg body weight/day) |
Phosphorous |
Globulin |
Albumin/Globulin ratio |
Blood Urea Nitrogen |
Cholinesterase |
Total Bilirubin |
Sodium |
Potassium |
Chloride |
|
(PHO) |
(GLO) |
(A/G Ratio) |
(BUN) |
(CHE) |
(BIT) |
(Na) |
(K) |
(CLO) |
||
mg/dL |
g/dL |
mg/dL |
mg/dL |
U/L |
mg/dL |
mmol/L |
mmol/L |
mmol/L |
||
Animals sacrificed on day 29 |
||||||||||
0 |
Mean |
7.58 |
3.51 |
0.95 |
10.44 |
158.00 |
0.00 |
154.56 |
4.83 |
113.20 |
±SD |
0.66 |
0.35 |
0.12 |
1.87 |
23.89 |
0.00 |
1.06 |
0.30 |
2.16 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
100 |
Mean |
7.34 |
3.22 |
1.01 |
6.52* |
163.60 |
0.00 |
153.06 |
4.74 |
111.42 |
±SD |
0.53 |
0.20 |
0.08 |
2.05 |
30.06 |
0.00 |
1.68 |
0.19 |
1.10 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
300 |
Mean |
7.54 |
3.28 |
1.01 |
6.95* |
152.60 |
0.02* |
150.12* |
4.89 |
109.06* |
±SD |
0.52 |
0.26 |
0.12 |
1.65 |
11.44 |
0.02 |
2.67 |
0.21 |
1.86 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
7.44 |
3.36 |
1.01 |
6.45* |
153.60 |
0.01 |
154.24 |
4.86 |
112.72 |
±SD |
0.55 |
0.21 |
0.07 |
1.41 |
31.67 |
0.01 |
2.58 |
0.28 |
1.88 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Animals sacrificed on day 43 (recovery animals) |
||||||||||
0 |
Mean |
5.94 |
3.41 |
0.90 |
8.83 |
174.00 |
0.00 |
143.32 |
3.47 |
103.88 |
±SD |
0.13 |
0.11 |
0.06 |
2.15 |
27.18 |
0.01 |
0.98 |
0.09 |
1.33 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
5.78 |
3.41 |
0.93 |
9.64 |
167.00 |
0.02 |
143.12 |
3.58 |
104.90 |
±SD |
0.34 |
0.34 |
0.12 |
2.85 |
27.22 |
0.02 |
0.47 |
0.18 |
1.26 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals; *. The mean difference is significant at the 0.05 level.
Table 3-3: SUMMARY OF CLINICAL CHEMISTRY RECORD FOR FEMALES
Dose (mg/kg body weight/day) |
Glucose |
Urea |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
Alanine aminotransferase |
Aspartate aminotransferase |
Alkaline phosphatase |
Calcium |
|
(GLU) |
|
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
(ALT) |
(AST) |
(ALP) |
(CAL) |
||
mg/dL |
mg/dL |
mg/dL |
mg/dL |
mg/dL |
g/dL |
g/dL |
U/L |
U/L |
U/L |
mg/dL |
||
Animals sacrificed on day 29 |
||||||||||||
0 |
Mean |
113.40 |
24.36 |
0.50 |
62.20 |
49.40 |
6.98 |
3.66 |
41.80 |
97.00 |
160.40 |
11.10 |
±SD |
7.40 |
2.65 |
0.03 |
6.98 |
8.96 |
0.31 |
0.14 |
9.50 |
9.19 |
25.34 |
0.36 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
100 |
Mean |
124.00 |
19.32 |
0.48 |
66.20 |
64.60 |
6.68 |
3.71 |
43.40 |
96.00 |
183.80 |
10.66 |
±SD |
21.04 |
8.48 |
0.04 |
10.47 |
17.29 |
0.13 |
0.05 |
9.99 |
14.14 |
44.20 |
0.65 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
300 |
Mean |
112.00 |
18.30 |
0.45 |
74.80 |
60.20 |
6.74 |
3.54 |
49.80 |
112.00 |
188.20 |
10.24 |
±SD |
15.72 |
5.21 |
0.05 |
6.06 |
12.97 |
0.38 |
0.12 |
11.05 |
28.37 |
12.05 |
0.61 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
102.40 |
18.40 |
0.46 |
75.80* |
52.20 |
7.28 |
3.80 |
52.60 |
96.60 |
261.40 |
10.04* |
±SD |
6.84 |
4.10 |
0.05 |
7.26 |
16.41 |
0.23 |
0.12 |
4.56 |
17.78 |
148.07 |
0.66 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Animals sacrificed on day 43 (recovery animals) |
||||||||||||
0 |
Mean |
103.80 |
20.96 |
0.57 |
52.00 |
47.80 |
6.66 |
3.23 |
42.00 |
92.60 |
129.20 |
8.98 |
±SD |
6.69 |
5.23 |
0.03 |
1.87 |
13.63 |
0.35 |
0.09 |
5.96 |
9.21 |
54.05 |
0.29 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
101.40 |
24.04 |
0.56 |
61.60* |
72.20 |
6.38 |
3.30 |
36.00 |
90.80 |
105.80 |
9.06 |
±SD |
5.18 |
4.28 |
0.06 |
7.37 |
24.48 |
0.16 |
0.18 |
5.52 |
7.33 |
28.70 |
0.50 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals; *. The mean difference is significant at the 0.05 level.
Table 3-4: SUMMARY OF CLINICAL CHEMISTRY RECORD FOR FEMALES
Dose (mg/kg body weight/day) |
Phosphorous |
Globulin |
Albumin/Globulin ratio |
Blood Urea Nitrogen |
Cholinesterase |
Total Bilirubin |
Sodium |
Potassium |
Chloride |
|
(PHO) |
(GLO) |
(A/G Ratio) |
(BUN) |
(CHE) |
(BIT) |
(Na) |
(K) |
(CLO) |
||
mg/dL |
g/dL |
mg/dL |
mg/dL |
U/L |
mg/dL |
mmol/L |
mmol/L |
mmol/L |
||
Animals sacrificed on day 29 |
||||||||||
0 |
Mean |
6.96 |
3.32 |
1.11 |
11.37 |
513.00 |
0.03 |
152.40 |
4.79 |
112.38 |
±SD |
0.30 |
0.23 |
0.07 |
1.24 |
200.57 |
0.03 |
2.75 |
0.41 |
2.78 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
100 |
Mean |
7.00 |
2.97 |
1.25* |
9.02 |
380.00 |
0.01 |
153.86 |
4.83 |
114.60 |
±SD |
0.48 |
0.15 |
0.07 |
3.96 |
98.16 |
0.01 |
3.18 |
0.35 |
3.75 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
300 |
Mean |
7.08 |
3.20 |
1.12 |
8.54 |
309.20* |
0.01 |
153.34 |
5.01 |
112.34 |
±SD |
0.29 |
0.33 |
0.11 |
2.43 |
29.52 |
0.02 |
1.88 |
0.43 |
2.28 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
7.32 |
3.48 |
1.10 |
8.59 |
476.00 |
0.02 |
155.30 |
4.76 |
115.44 |
±SD |
0.94 |
0.19 |
0.07 |
1.91 |
85.69 |
0.02 |
1.56 |
0.33 |
1.29 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Animals sacrificed on day 43 (recovery animals) |
||||||||||
0 |
Mean |
4.08 |
3.43 |
0.95 |
9.78 |
418.60 |
0.00 |
142.30 |
3.56 |
103.96 |
±SD |
2.01 |
0.28 |
0.06 |
2.44 |
105.36 |
0.03 |
1.39 |
0.28 |
1.12 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
5.38 |
3.08 |
1.08 |
11.22 |
454.80 |
0.02 |
143.30 |
3.61 |
104.38 |
±SD |
0.53 |
0.27 |
0.15 |
2.00 |
148.08 |
0.04 |
1.61 |
0.30 |
2.69 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals; *. The mean difference is significant at the 0.05 level.
Table 4 -1: SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g) FOR MALES
Dose (mg/kg body weight/day) |
Adrenals |
Thymus |
Spleen |
Epididymes/ Uterus |
Testes/ Ovaries |
Heart |
Kidneys |
Brain |
Liver |
Prostate+Seminal vesicles with coagulating glands (PSC) |
|
Animals sacrificed on day 29 |
|||||||||||
0 |
Mean |
0.0483 |
0.4606 |
0.5708 |
0.9083 |
3.0201 |
1.0835 |
2.0651 |
1.9668 |
10.5234 |
1.8954 |
±SD |
0.0034 |
0.0943 |
0.1500 |
0.1120 |
0.1713 |
0.1911 |
0.3345 |
0.1332 |
1.9888 |
0.3913 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
100 |
Mean |
0.0488 |
0.4182 |
0.5165 |
0.8639 |
2.9240 |
1.1796 |
2.1493 |
1.9938 |
10.7583 |
1.8386 |
±SD |
0.0071 |
0.0757 |
0.1086 |
0.1179 |
0.5206 |
0.2400 |
0.1715 |
0.0709 |
0.7062 |
0.4282 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
300 |
Mean |
0.0520 |
0.4351 |
0.6032 |
0.8777 |
3.0423 |
1.0541 |
2.2062 |
2.0253 |
11.5609 |
1.9436 |
±SD |
0.0109 |
0.0856 |
0.0976 |
0.0489 |
0.2532 |
0.1404 |
0.2607 |
0.0387 |
1.6337 |
0.4910 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
0.0543 |
0.4018 |
0.5382 |
0.9725 |
3.1035 |
0.9934 |
2.0214 |
2.0664 |
11.5706 |
1.8636 |
±SD |
0.0090 |
0.0890 |
0.0517 |
0.1163 |
0.3229 |
0.1047 |
0.2636 |
0.0997 |
1.3157 |
0.2603 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Animals sacrificed on day 43 (recovery animals) |
|||||||||||
0 |
Mean |
0.0515 |
0.5546 |
0.6454 |
1.2785 |
3.1981 |
1.2739 |
2.8651 |
2.0476 |
11.3674 |
2.7965 |
±SD |
0.0047 |
0.0700 |
0.0436 |
0.0742 |
0.0610 |
0.1003 |
0.3773 |
0.1157 |
0.6824 |
0.2325 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
0.0561 |
0.4934 |
0.5703* |
1.2227 |
3.1419 |
1.2951 |
2.5595 |
2.0857 |
10.3506* |
3.1057 |
±SD |
0.0103 |
0.0392 |
0.0256 |
0.1144 |
0.2042 |
0.1153 |
0.4456 |
0.0620 |
0.6893 |
0.4037 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals; *. The mean difference is significant at the 0.05 level.
Table 4-2: SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g) FOR FEMALES
Dose (mg/kg body weight/day) |
Adrenals |
Thymus |
Spleen |
Uterus |
Ovaries |
Heart |
Kidneys |
Brain |
Liver |
|
Animals sacrificed on day 29 |
||||||||||
0 |
Mean |
0.0604 |
0.4292 |
0.4767 |
0.4349 |
0.1345 |
0.9491 |
1.5955 |
1.9396 |
7.9994 |
±SD |
0.0114 |
0.0936 |
0.0541 |
0.0869 |
0.0447 |
0.1087 |
0.1312 |
0.0399 |
0.6383 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
100 |
Mean |
0.0627 |
0.5004 |
0.4412 |
0.4209 |
0.1373 |
0.8667 |
1.5871 |
1.9428 |
8.0021 |
±SD |
0.0074 |
0.0651 |
0.0457 |
0.0950 |
0.0214 |
0.0616 |
0.1050 |
0.0308 |
0.2780 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
300 |
Mean |
0.0554 |
0.4624 |
0.4608 |
0.4575 |
0.1240 |
0.8119 |
1.6024 |
1.8825 |
7.9831 |
±SD |
0.0069 |
0.0980 |
0.0806 |
0.1626 |
0.0183 |
0.1242 |
0.2708 |
0.0834 |
1.0254 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
0.0588 |
0.3895 |
0.4226 |
0.3980 |
0.1203 |
0.7775* |
1.3864 |
1.8554 |
8.1730 |
±SD |
0.0095 |
0.0278 |
0.0338 |
0.0605 |
0.0225 |
0.0700 |
0.1037 |
0.0892 |
0.6379 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Animals sacrificed on day 43 (recovery animals) |
||||||||||
0 |
Mean |
0.0646 |
0.4612 |
0.5441 |
0.6062 |
0.1627 |
0.9888 |
1.9524 |
2.0064 |
8.0022 |
±SD |
0.0082 |
0.0468 |
0.1081 |
0.0789 |
0.0291 |
0.0827 |
0.2423 |
0.0759 |
0.3885 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
1000 |
Mean |
0.0802* |
0.5168* |
0.5357 |
0.5486 |
0.2238 |
1.0916 |
1.8898 |
1.9589 |
8.9898 |
±SD |
0.0120 |
0.0229 |
0.0874 |
0.1217 |
0.0713 |
0.1160 |
0.1645 |
0.0543 |
1.3322 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
SD: Standard Deviation; n: number of animals; *. The mean difference is significant at the 0.05 level.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- One recently performed guideline study
Additional information
Justification for classification or non-classification
The repeated dose toxicity of the registration substance Genagen PA/N.N-Dimethylnonamide was evaluated according to the Guideline OECD 407.
No significant effect was found up to the highest dose of 1000 mg/kg bw. The NOAEL of 1000 mg/kg bw/day was obtained.
No classification is justified.
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