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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental Starting Date: 07 May 2021 and Experimental Completion Date: 08 June 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17th December 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Identification: FAT 40879/B TE
Appearance: Dark red powder, solid at 20 °C
Batch Number: BOP 05-20 (MC-0065114700/800 1:1)
Purity: 80.5 % all colored organic constituents; main constituent 66.9 %
pH: 6.7 at concentration of 2 % (w/w) in water
Manufacture Date: June 26, 2020
Expiry Date: September 08th, 2025
Storage Conditions: Freezer (-15 to -20 °C)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:
Animal Breeding, RCC Laboratories India Private Limited, Genome Valley, Turkapally, Shameerpet (Mandal) Ranga Reddy District, Hyderabad – 500 078 India.
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
Yes
- Age at study initiation:
09 -12 weeks
- Weight at study initiation:
158.4 to 198.6 g
- Fasting period before study:
18.0 h
- Housing: Housed in groups of three animals, by dose, each in Polycarbonate cages
- Diet: Teklad Certified Global 14 % protein rodent maintenance diet (Batch No.2014C-091720MA) was provided ad libitum
- Water: UV purified water was provided ad libitum
- Acclimation period: Under laboratory conditions for 07 days for Step I, 12 days for Step II, 15 days for Step III and 06 days for Step IV animals, after veterinary examination.
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 to 22.9
- Humidity (%): 61 to 69
- Air changes (per hr): The animal room was air-conditioned with adequate (above 10) air changes per hour.
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark.

IN-LIFE DATES: From: May 13, 2021 To: June 08 2021

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The dose volume was 10 mL/kg body weight. The animals were gavaged using 15 G oral plastic feeding tubes.
ORDER
In Step I, 03 female rats received a single dose of the test item by oral gavage administration at 300 mg/Kg body weight. No mortality was observed in all three treated animals.
In Step II, 03 naive female rats were again treated with the same dose of 300 mg/Kg body weight. No mortality was observed in all three treated animals.
In Step III, 03 naive female rats were treated at the next higher dose of 2000 mg/Kg body weight. No mortality was observed in all three treated animals.
In Step IV, 03 naive female rats were again treated with the same dose of 2000mg/Kg body weight. No mortality was observed in all three treated animals.
As there was no mortality at the highest dose of 2000 mg/Kg body weight, hence no further testing was carried out.
Doses:
Step 1 and step 2: 300 mg/kg
Step 3 and step 4: 2000 mg/kg
No. of animals per sex per dose:
3 female animals per step.
2 steps per dose (Total 6 female animals per dose)
Control animals:
no
Details on study design:
Mortality / Viability: Twice Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 4 hours after administration on test day 0 (in common with the clinical signs) and twice daily during days 1-14 (once on the day of receipt, on holidays and days of terminal sacrifice).
Body weights: On the day of commencement of acclimatization, on test days 0 (prior to dose administration), day 07, and 14.
Clinical signs: Once daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 4 hours post test item administration on test day 0. Once daily during days 1-14
Statistics:
No statistical analysis was performed. Mean and Statistical Analysis was performed using validated Excel.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in any of the treated animals of Step I, Step II , Step III and Step IV ( 300 and 2000 mg/Kg body weight)
Clinical signs:
other: All the animals of Step I (Animal No. 01, 02 and 03) and Step II (Animal No. 04, 05 and 06) treated at 300 mg/Kg body weight and all the animals of Step III (Animal No. 07, 08 and 09) and Step IV (Animal No. 10, 11 and 12) treated at 2000 mg/Kg body weigh
Gross pathology:
No gross pathological abnormalities were observed in any of the treated and surviving animals at terminal sacrifice, hence histopathologic analysis was not necessary.

Any other information on results incl. tables

MORTALITY / CLINICAL SIGNS

Dose

Step

Animal

Number

Sex

Test day

0*

1

2

3

4

5

6

7

8

9

10

11

12

13

14

0.5

1

2

3

4

300

mg/Kg body weight

I

01

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

02

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

03

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

II

04

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

05

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

06

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

2000

mg/Kg body weight

III

07

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

08

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

09

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

IV

10

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

11

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

12

F

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

 

BODY WEIGHT AND MEAN PERCENT BODY WEIGHT CHANGES

A.No

Sex

Body weight (g)

Body weight Change (%)

Acclimatization

Day 0

Day 7

Day 14

(Day 0-7)

(Day 0-14 )

1

Female

168.6

188.0

203.2

224.4

8.1

19.4

2

Female

170.0

186.2

201.4

221.4

8.2

18.9

3

Female

166.5

182.4

197.6

218.8

8.3

20.0

MEAN

168.4

185.5

200.7

221.5

8.2

19.4

SD

1.41

2.33

2.33

2.29

0.10

0.43

4

Female

162.6

188.3

209.6

230.2

11.3

22.3

5

Female

159.2

186.5

207.4

228.6

11.2

22.6

6

Female

159.0

182.1

203.2

224.8

11.6

23.4

MEAN

160.2

185.6

206.7

227.9

11.4

22.8

SD

1.63

2.60

2.65

2.26

0.16

0.51

7

Female

151.3

198.6

218.8

239.6

10.2

20.6

8

Female

146.2

186.4

206.6

227.4

10.8

22.0

9

Female

159.8

184.0

204.2

225.0

11.0

22.3

MEAN

152.4

189.7

209.9

230.7

10.7

21.6

SD

5.61

6.39

6.39

6.39

0.35

0.71

10

Female

165.7

171.6

192.2

213.0

12.0

24.1

11

Female

158.6

165.8

186.4

207.6

12.4

25.2

12

Female

156.4

158.4

179.6

200.8

13.4

26.8

MEAN

160.2

165.3

186.1

207.1

12.6

25.4

SD

3.97

5.40

5.15

4.99

0.58

1.08

MACROSCOPIC FINDINGS

Dose

Step

Animal

Number

Sex

Mode of death

Macroscopic findings

300  mg/Kg

body weight

I

01

Female

Terminal Sacrifice

No Abnormality Detected

02

Female

Terminal Sacrifice

No Abnormality Detected

03

Female

Terminal Sacrifice

No Abnormality Detected

II

04

Female

Terminal Sacrifice

No Abnormality Detected

05

Female

Terminal Sacrifice

No Abnormality Detected

06

Female

Terminal Sacrifice

No Abnormality Detected

2000  mg/Kg

body weight

III

07

Female

Terminal Sacrifice

No Abnormality Detected

08

Female

Terminal Sacrifice

No Abnormality Detected

09

Female

Terminal Sacrifice

No Abnormality Detected

IV

10

Female

Terminal Sacrifice

No Abnormality Detected

11

Female

Terminal Sacrifice

No Abnormality Detected

12

Female

Terminal Sacrifice

No Abnormality Detected

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results, the median lethal dose (LD50) of FAT 40879/B after single oral administration to female rats, observed over a period of 14 days is LD50 cut-off value of 5000 mg/Kg body weight and the estimated acute toxicity is between 2000 < ATE ≤ 5000.
Executive summary:

In a GLP-compliant study conducted according to OECD guideline 423, FAT 40879/B was administered to Wistar rats by oral gavage at a dose level of 300 mg/Kg body weight and 2000 mg/kg body weight to 2 dose groups in 4 steps. The first two steps (Step I & II) represents the dose group of 300 mg/kg bodyweight and the next two steps (Step III & IV) represents the dose group of 2000 mg/Kg bodyweight. Three animals were allocated at each step. The test item was formulated in vehicle (distilled water) at a concentration of 30 mg/mL for Step I and Step II and 200 mg/mL for Step III and Step IV, administered at a dose volume of 10 mL/kg body weight.


The animals were treated as follows:


Step I            3 females treated at 300 mg/kg       


Step II           3 females treated at 300 mg/kg      


Step III          3 females treated at 2000 mg/kg     


Step IV         3 females treated at 2000 mg/kg     


The animals were observed daily during the acclimatization period for mortality/viability and clinical signs and observations were recorded. All the animals were observed for clinical signs during first 30 minutes and at approximately 1, 2, 3 and 4 hours after administration of test item on test day 0 and once daily during test days 1‑14. Mortality/viability was recorded during first 30 minutes and at approximately 1, 2, 3 and 4 hours after administration of test item on test day 0 (in common with the clinical signs) and twice daily during days 1-14 (once on the day of receipt, on holidays and days of terminal sacrifice). Body weights were re­corded on test day 0 (prior to administration), and on day 7 and 14. All treated and surviving animals were necropsied and examined macroscopically at the end of observation period. All animals appeared normal throughout the acclimatization period. All animals of Step I (Animal No. 01, 02 and 03) and Step II (Animal No. 04, 05 and 06) treated at 300 mg/kg body weight and all the animals of Step III (Animal No. 07, 08 and 09) and Step IV (Animal No. 10, 11 and 12) treated at 2000 mg/kg body weight appeared normal at first 30 minutes, 1, 2, 3, and 4 hour observation on test day 0 after treatment and throughout the experiment period (up to day 14). The body weight of the animals was considered to be within the normal range of variability commonly recorded for this species, strain and age. There was body weight gain in all the animals by days 7 and 14 as compared to day 0. No gross pathological abnormalities were observed in any of the treated animals at terminal sacrifice, hence histopathology analysis was not necessary. Based on the results, the median lethal dose (LD50) of FAT 40879/B after single oral administration to female rats, observed over a period of 14 days is LD50 cut-off value of 5000 mg/kg body weight and the estimated acute toxicity is between 2000 < ATE ≤ 5000.