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EC number: - | CAS number: -
- 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
Acute Toxicity: oral
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:
- 2 021
- 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.
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