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EC number: 888-364-4 | CAS number: 146569-48-4
- 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 test material was tested for acute oral and inhalation toxicity in GLP compliant studies according to respective OECD test guidelines (OECD TG 423 & 403). The test item was applied either via gavage (vehicle: 0.5% w/v CMC) or as an aerosol to Sprague Dawley rats.
Regarding acute oral toxicity, step wise approach was performed applying single doses of 300 mg/kg bw in the first step and 2,000 mg/kg bw in the second step. No clinical signs, mortalities, changes in bodyweight and percent change in body weight or pathological changes were observed in both steps. Hence, a LD50 > 2,000 mg/kg is suggested.
In the context of acute inhalation toxicity, a limit test with 5.04 mg/L exposed through flow-past nose-only dynamic inhalation equipement for 4 h was performed. The aerosol obtained MMAD of 2.86 - 3.18 µm with a GSD of 2.55-2.58. After exposure, no treatment related clinical signs of toxicity and mortalities were observed. Slight decrease in body weight was noted on Day 2 due to exposure. All animals showed increase in body weight on day 4, 8 and 15. No treatment related gross pathological findings were observedat the mean maximum achievable concentration of 5.04mg/L of air. In conclusion, a LC50 > 5.04 mg/L was obtained.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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 - 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 - 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 - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- 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
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 October 2020 to 18 November 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 403 – Traditional Protocol “Acute Inhalation Toxicity” adopted on 07 September 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Clariant Produkte (Deutschland) GmbH
83052 Bruckmühl/Heufeld
Germany
and EX.14402.600
- Expiration date of the 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)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Aerosol
- Preliminary purification step (if any): No - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks
- Weight at study initiation: Males : 183.27 g to 191.12 g
Females : 167.28 g to 175.15 g
- Fasting period before study: No
- Housing: standard polypropylene cage (size: L 430 × B 285 × H 150 mm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 29 October 2020 to 03 November 2020
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0°C to 22.9°C
- Humidity (%): 49% to 64%
- 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: 29 October 2020 To: 18 November 2020 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- > 2.86 - <= 3.18 µm
- Geometric standard deviation (GSD):
- > 2.55 - <= 2.58
- Remark on MMAD/GSD:
- All the values were within the acceptable range
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow-past, nose-only dynamic inhalation exposure system supplied by CH Technologies, USA
- Exposure chamber volume: 0.76 L
- Method of holding animals in test chamber: restrainer
- Source and rate of air: compressor air and 20 L/min
- Method of conditioning air: purified air
- System of generating particulates/aerosols: Palas RBG 1000
- Method of particle size determination: 7 stage cascade mercer impactor
- Treatment of exhaust air: NaOH
- Temperature, humidity, pressure in air chamber: 22.4 to 22.6°C, 55.3 to 55.9%, 60psi
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically
- Samples taken from breathing zone: yes
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Based on technical pre-test and achieved limit concentration i.e., 5 mg/L. - Analytical verification of test atmosphere concentrations:
- no
- Remarks on duration:
- 4 hours exposure
- Concentrations:
- Limit concentration 5 mg/L
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily thereafter for clinical signs and twice daily for mortality and weighing on day 1, 2, 4, 8 and 15
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.04 mg/L air
- Based on:
- test mat.
- Body weight:
- No substance related changes were observed in body weight and percent change in body weight with respect to day 1 at the mean maximum achievable concentration of 5.04 mg/L of air. However, all animals showed slight decrease in body weight on day 2 due to restraining of animals during exposure. This slight change was transient and no clinical signs were observed during the experimental period. All animals increased in body weight from day 4 onwards
- Gross pathology:
- No treatment related gross pathological findings were observed at the maximum achievable concentration of 5.04 mg/L of air
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed and based on the above results of experiment, there were no clinical signs and mortality observed at mean maximum achievable concentration of 5.04 mg/L of air. Hence, the LC50 of the test item is > 5.04 mg/L of air. This result, taking into account that there is no identification of a harm of acute nature towards vulnerable populations, does not justify a classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
The test item was evaluated for acute inhalation toxicity in Sprague Dawley rats.
The objective of the study was to assess the toxic potential and to determine the LC50 of test item when administered by inhalation route through flow-past nose-only dynamic inhalation equipment for a single 4 hours exposure to rats. Three male and three female rats were used for conducting the acute inhalation toxicity study.
As such test item was used during technical pre-test and limit test to generate the dust aerosols through rotating brush generator. The technical pre-test was carried out without animals. During the technical pre-test, the target concentration i.e. 5.04 mg/L of air was achieved.
During the exposure period, the temperature, relative humidity, oxygen and carbon dioxide concentration of the chamber were 22.4°C to 22.6°C, 55.3% to 55.9%, 20.2% to 20.4% and 618 ppm to 620 ppm (0.06%) respectively for limit test. The particle size MMAD and GSD were 2.86 µm to 3.18 µm and 2.55 to 2.58 respectively. All the values were within theacceptablerange. The mean maximum achievable breathing zone concentration (actual concentration) was 5.04 mg/Lof airand it was considered as the limit concentration.
All the animals were observed for clinical signs and pre-terminal deaths at 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) during exposure and 30 to 40 minutes and 1 hour (±10 mins) post-exposure on day 1 and once daily thereafter for clinical signs and twice daily for mortality till 14 days post exposure period.Individual animal body weight was recorded on day 1 (on the day of exposure) prior to the exposure and on day 2, 4, 8 and 15. During exposure period, the chamber (exposure) conditions were recorded. All rats were euthanized after 14 days post exposure period by intraperitoneal administration of sodium thiopentone and the gross pathological findings were recorded.
No treatment related clinical signs of toxicity and mortalities were observed. Slight decrease in body weight was noted on Day 2 due to exposure. All animals showed increase in body weight on day 4, 8 and 15.
No treatment related gross pathological findings were observed atthe mean maximum achievable concentration of 5.04mg/L of air.
This result, taking into account that there is no identification of a harm of acute nature towards vulnerable populations, does not justify a classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Reference
TABLE 1. CLINICAL SIGNS AND MORTALITY RECORD
Group & Concentration (mg/L of air) | Animal No. | Sex | Day 1 | Days | |||||||||||||||||||||||||||||||||||||||||
During Exposure | Post exposure | ||||||||||||||||||||||||||||||||||||||||||||
1 hr* | 2 hrs* | 3 hrs* | 4 hrs* | 30-40 min | 1 hr* | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||||||||||||||||||||||||||
Limit Test & 5.04 | Re9026 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |||||||||||||||||||||||
Re9027 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9028 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9029 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9030 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9031 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
*: ± 10 minutes; N: Normal; M: Male; F: Female; min: minute; hr(s): hour(s)
TABLE 2. BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT (%) WITH RESPECT TO DAY 1
Group & Concentration (mg/L of air) | Animal No. | Sex | Body Weight (g) on Days |
| Percent Change in Body Weight with Respect to Day 1 | ||||||||||||||||||||
1# | 2 | 4 | 8 | 15 |
| 1-2 | 1-4 | 1-8 | 1-15 | ||||||||||||||||
Limit Test & 5.04 | Re9026 | M | 202.42 | 200.20 | 203.27 | 216.43 | 238.59 |
| -1.10 | 0.42 | 6.92 | 17.87 | |||||||||||||
Re9027 | M | 211.59 | 209.87 | 213.11 | 227.74 | 249.45 |
| -0.81 | 0.72 | 7.63 | 17.89 | ||||||||||||||
Re9028 | M | 206.11 | 205.46 | 207.65 | 221.55 | 247.01 |
| -0.32 | 0.75 | 7.49 | 19.84 | ||||||||||||||
Mean |
| 206.71 | 205.18 | 208.01 | 221.91 | 245.02 |
| -0.74 | 0.63 | 7.35 | 18.54 | ||||||||||||||
(±) SD |
| 4.61 | 4.84 | 4.93 | 5.66 | 5.70 |
| 0.40 | 0.18 | 0.38 | 1.13 | ||||||||||||||
n |
| 3 | 3 | 3 | 3 | 3 |
| 3 | 3 | 3 | 3 | ||||||||||||||
Re9029 | F | 182.63 | 180.22 | 184.83 | 193.16 | 210.09 |
| -1.32 | 1.20 | 5.77 | 15.04 | ||||||||||||||
Re9030 | F | 191.80 | 189.30 | 193.42 | 203.88 | 214.76 |
| -1.30 | 0.84 | 6.30 | 11.97 | ||||||||||||||
Re9031 | F | 186.47 | 185.06 | 188.09 | 199.60 | 212.69 |
| -0.76 | 0.87 | 7.04 | 14.06 | ||||||||||||||
Mean |
| 186.97 | 184.86 | 188.78 | 198.88 | 212.51 |
| -1.13 | 0.97 | 6.37 | 13.69 | ||||||||||||||
(±) SD |
| 4.61 | 4.54 | 4.34 | 5.40 | 2.34 |
| 0.32 | 0.20 | 0.64 | 1.57 | ||||||||||||||
n |
| 3 | 3 | 3 | 3 | 3 |
| 3 | 3 | 3 | 3 |
#: Prior to exposure;M: Male; F: Female;SD: Standard Deviation, n: Number of animals
TABLE 3. BREATHING ZONE CONCENTRATION (ACTUAL TEST ITEM CONCENTRATION)
Technical Pre-test:
Sl. No. | Feed rate (mm/hour) | Rotation (rpm) | Initial weight (mg) (a) | Final weight (mg) (b) | Difference (mg) (c) = (b) – (a) | Air Flow Rate (L/min) (d) | Time (min) (e) | BZC (mg/L of air)
|
Mean BZC (mg/L of Air) | ||||||||||
1 | 012 | 600 | 345.61 | 349.85 | 4.24 | 0.84 | 1 | 5.05 | 5.05 | ||||||||||
2 | 012 | 600 | 346.60 | 350.85 | 4.25 | 0.84 | 1 | 5.06 |
Limit Test:
Sl. No. | Feed rate (mm/hour) | Rotation (rpm) | Initial weight (mg) (a) | Final weight (mg) (b) | Difference (mg) (c) = (b) – (a) | Air Flow Rate (L/min) (d) | Time (min) (e) | BZC (mg/L of air)
| Mean BZC (mg/L of Air) | ||||||||||
1 | 012 | 600 | 346.63 | 350.85 | 4.22 | 0.84 | 1 | 5.02 | 5.04 | ||||||||||
2 | 012 | 600 | 343.84 | 348.09 | 4.25 | 0.84 | 1 | 5.06 | |||||||||||
3 | 012 | 600 | 349.44 | 353.67 | 4.23 | 0.84 | 1 | 5.04 |
BZC: Breathing Zone Concentration; Sampled volume: 0.84 L/min; Sampling time: 1 minute
BZC (f) = | Mass of test item collected on the filter paper (c) | ||
Volume of air passed through the filter paper (d) X time (e) |
TABLE 4. CHAMBER (EXPOSURE) CONDITIONS
Technical Pre-test:
Concentration (mg/L of air) | SL. No. | Feed rate (mm/hour) | Rotation (rpm) | Temperature (°C) | Relative Humidity (%) | Oxygen Concentration (%) | Carbon dioxide Concentration (ppm) | Air Flow (L/min) |
5.05 | 1 | 012 | 600 | 22.7 | 55.6 | 20.2 | 615 | 20 |
2 | 012 | 600 | 22.4 | 56.2 | 20.5 | 612 | 20 |
Limit Test:
Concentration (mg/L of air) | SL. No. | Feed rate (mm/hour) | Rotation (rpm) | Temperature (°C) | Relative Humidity (%) | Oxygen Concentration (%) | Carbon dioxide Concentration (ppm) | Air Flow (L/min) |
5.04 | 1 | 012 | 600 | 22.6 | 55.9 | 20.4 | 618 | 20 |
2 | 012 | 600 | 22.4 | 55.7 | 20.3 | 619 | 20 | |
3 | 012 | 600 | 22.5 | 55.3 | 20.2 | 620 | 20 |
Note: 1% Carbon dioxide = 10000 ppm
TABLE 5. GROSS PATHOLOGICAL FINDINGS
Group &Concentration (mg/L of air) | Animal No. | Sex | Fate | Gross Pathology Findings | |
External | Internal | ||||
Limit Test & 5.04 | Re9026 | M | TS | NAD | NAD |
Re9027 | M | TS | NAD | NAD | |
Re9028 | M | TS | NAD | NAD | |
Re9029 | F | TS | NAD | NAD | |
Re9030 | F | TS | NAD | NAD | |
Re9031 | F | TS | NAD | NAD |
NAD: No Abnormality Detected; M: Male; F: Female; TS: Terminal Sacrifice
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 5.04 mg/L air
- Physical form:
- inhalation: aerosol
Additional information
Justification for classification or non-classification
The test material does not fulfill the requirements for classification. Hence, no classification with regard to acute oral and acute inhalation toxicity is warranted.
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