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EC number: 888-364-4 | CAS number: 146569-48-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 October 2020 to 30 November 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted on 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- niobium trivanadium decamolybdenum tellurium dotetracontaoxide
- EC Number:
- 888-364-4
- Cas Number:
- 146569-48-4
- Molecular formula:
- Mo10V3Nb1Te1O42
- IUPAC Name:
- niobium trivanadium decamolybdenum tellurium dotetracontaoxide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: EX. 14402. 600
- Expiration date of the lot/batch: No change of properties known over time (endless)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
FORM AS APPLIED IN THE TEST (if different from that of starting material): formulation
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 160.03 g to 174.24 g
- Fasting period before study: 16 to 18 hours
- Housing: standard polypropylene cage (L 430 x B 285 x H 150 mm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 16 October 2020 to 28 October 2020
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9°C to 22.9°C
- Humidity (%): 46% to 66%
- 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
IN-LIFE DATES: From: 21 October 2020 To: 12 November 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg and 2000 mg of test item
- Amount of vehicle (if gavage): volume made up to 10 mL
- Justification for choice of vehicle: Carboxy Methyl Cellulose is universally accepted and routinely used vehicle in oral toxicity studies
- Lot No.: BCBN1690V
- Rationale for the selection of the starting dose: A starting dose of 300 mg/kg body weight has been selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight, as the LD50 of test item is not available - Doses:
- 300 and 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 animals per Step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period
Individual animal body weight was recorded at receipt, on day 1 (before test item administration), on day 8 and 15 during the observation period
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
TABLE 1. INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY ANDMORTALITY RECORD
Study Steps & Dose (mg/kg body weight) |
Animal No. |
Sex |
Time of Dosing (AM) |
Clinical Signs of Toxicity and Mortality on Day 1 |
Clinical Signs of Toxicity and Mortality on Day |
|||||||||||||||||
20 to 30 min |
1 hr (±10 min) |
2hrs (±10 min) |
3hrs (±10 min) |
4hrs (±10 min) |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
Step-I & 300 |
Re8891 |
F |
10:26 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Re8892 |
F |
10:27 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Re8893 |
F |
10:28 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Step-I Confirmation & 300 |
Re8894 |
F |
9:47 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Re8895 |
F |
9:48 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Re8896 |
F |
9:49 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Step-II & 2000 |
Re8897 |
F |
10:36 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Re8898 |
F |
10:37 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Re8899 |
F |
10:37 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Step-II confirmation & 2000 |
Re8900 |
F |
10:21 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Re8901 |
F |
10:22 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Re8902 |
F |
10:23 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
N: Normal; F: Female; min: minutes; hr/hrs: Hour/Hours
TABLE 2. INDIVIDUAL ANIMAL BODY WEIGHT (g) ANDPERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1
Study Steps & Dose (mg/kg body weight) |
Animal No. |
Sex |
Volume of Test Item Administered (mL) |
Body Weight (g) on Day |
|
Percent Change in Body Weight with Respect to Day |
|||
1 |
8 |
15 |
|
1 to 8 |
1 to 15 |
||||
Step-I & 300 |
Re8891 |
F |
1.5 |
152.06 |
178.90 |
210.90 |
|
17.65 |
38.70 |
Re8892 |
F |
1.6 |
164.16 |
187.99 |
206.04 |
|
14.52 |
25.51 |
|
Re8893 |
F |
1.6 |
155.21 |
183.92 |
205.88 |
|
18.50 |
32.65 |
|
Mean |
157.14 |
183.60 |
207.61 |
|
16.89 |
32.28 |
|||
±SD |
6.28 |
4.55 |
2.85 |
|
2.10 |
6.60 |
|||
Step-I Confirmation & |
Re8894 |
F |
1.5 |
153.27 |
187.31 |
215.10 |
|
22.21 |
40.34 |
Re8895 |
F |
1.5 |
152.21 |
185.52 |
210.11 |
|
21.88 |
38.04 |
|
Re8896 |
F |
1.6 |
155.36 |
188.32 |
220.43 |
|
21.22 |
41.88 |
|
Mean |
153.61 |
187.05 |
215.21 |
|
21.77 |
40.09 |
|||
±SD |
1.60 |
1.42 |
5.16 |
|
0.51 |
1.93 |
|||
Step-II & |
Re8897 |
F |
1.8 |
175.50 |
206.51 |
223.77 |
|
17.67 |
27.50 |
Re8898 |
F |
1.7 |
169.35 |
194.73 |
209.10 |
|
14.99 |
23.47 |
|
Re8899 |
F |
1.7 |
168.49 |
196.51 |
210.11 |
|
16.63 |
24.70 |
|
Mean |
171.11 |
199.25 |
214.33 |
|
16.43 |
25.23 |
|||
±SD |
3.82 |
6.35 |
8.19 |
|
1.35 |
2.07 |
|||
Step-II confirmation & |
Re8900 |
F |
1.8 |
175.52 |
206.32 |
220.65 |
|
17.55 |
25.71 |
Re8901 |
F |
1.8 |
175.51 |
207.07 |
225.20 |
|
17.98 |
28.31 |
|
Re8902 |
F |
1.8 |
179.64 |
206.80 |
220.59 |
|
15.12 |
22.80 |
|
Mean |
176.89 |
206.73 |
222.15 |
|
16.88 |
25.61 |
|||
±SD |
2.38 |
0.38 |
2.64 |
|
1.54 |
2.76 |
|||
F: Female
TABLE 3. INDIVIDUAL ANIMAL GROSS PATHOLOGY FINDINGS
Study Steps & Dose (mg/kg body weight) |
Animal No. |
Sex |
Fate |
Gross Pathology Findings |
|
External |
Internal |
||||
Step-I & 300 |
Re8891 |
F |
TS |
NAD |
NAD |
Re8892 |
F |
TS |
NAD |
NAD |
|
Re8893 |
F |
TS |
NAD |
NAD |
|
Step-I Confirmation & 300 |
Re8894 |
F |
TS |
NAD |
NAD |
Re8895 |
F |
TS |
NAD |
NAD |
|
Re8896 |
F |
TS |
NAD |
NAD |
|
Step-II & 2000 |
Re8897 |
F |
TS |
NAD |
NAD |
Re8898 |
F |
TS |
NAD |
NAD |
|
Re8899 |
F |
TS |
NAD |
NAD |
|
Step-II confirmation & 2000 |
Re8900 |
F |
TS |
NAD |
NAD |
Re8901 |
F |
TS |
NAD |
NAD |
|
Re8902 |
F |
TS |
NAD |
NAD |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the experiment, it is concluded that the LD50 cut off value for the test item, Mo10V3TeNbO42 is 2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals (No. 423, Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Acute Toxic Class Method” and unclassified as per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
- Executive summary:
The test item was evaluated for acute oral toxicity in Sprague Dawley rats.
As the LD50 of test item was not available, hence a starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight.
A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I and Step-I confirmation were administered with 300 mg/kg body weight of the test item and Step II and Step-II confirmation were administered with 2000 mg/kg body weight of the test item through oral route.
All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded at receipt, on day 1 before test item administration, on days 8 and 15 during the observation period. At the end of observation period, all the animals were humanely sacrificed by carbon dioxide asphyxiation, subjected to necropsy and gross pathological examination.
No clinical signs of toxicity and mortality was observed in any of the dosed animals.
No changes were observed in body weight and percent change in body weight with respect to day 1. All the animals revealed physiologically normal increase in the body weight.
No gross pathological changes were observed in any of the dosed animals
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