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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
In two GLP compliant OECD TG (439 & 431) the skin irritation and corrosion potency of the test item was evaluated. Further, OECD TG 437 and 405 were performed to evaluate the eye irritation potential.
Within the OECD TG 439, a viability measured via MTT assay of 45.7 % obtained. To to this result, the test item is considered as skin irritant Category 1 or 2 and a subsequent in vitro assay to elucidate the category (OECD TG 431) was performed.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 December 2020 To 29 March 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 439
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Principles of method if other than guideline:
- To evaluate the skin irritation potential of Mo10V3TeNbO42 using Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200- SIT).
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- With GLP Certificate
- Specific details on test material used for the study:
- Physical Appearance (with color): Solid (black)
Batch No.: EX.14402.600
Date of Manufacture: Oct 2017
Date of Expiry: No change of properties known over time (endless)
Storage Conditions: Ambient (21 to 29ºC) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In vitro Life Science Laboratories, s.r.o, MlynskéNivy 73, 821 05, Bratislava II, Slovak Republic, www.mattek.com; Phone: +421-2-3260-7401; Fax: +421-2-3260-7404.
- Justification for test system used:
- As recommended in OECD Guideline No. 439, Reconstructed Human Epidermal Model EpiDerm™ (EPI-200-SIT) has been selected as test system for in vitro skin irritation.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200-SIT) was used as test system
- Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- Quantity of 30 µL of DPBS (NC) and 5% SDS (PC) were dispensed directly atop the tissue at 1 minute intervals to facilitate rinsing of the NC and PC after exposure.
The tissues were exposed to 25 mg of test item. - Duration of treatment / exposure:
- 1 hour and 48 hours
- Duration of post-treatment incubation (if applicable):
- Percentage viability of tissues was measured by performing MTT assay after 60 minutes of treatment and post incubation of 43 hours and 7 minutes.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three replicates
- Value:
- 45.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results obtained under the laboratory testing conditions, the test item is categorized as irritant to Reconstructed Human Epidermis (RhE) in accordance with UN GHS (Category 2 or Category 1), as the mean percentage of tissue viability was less than 50% of the negative control after 60 minutes of exposure and 43 hours and 7 minutes post incubation.
Since a subsequent study performed according to OECD TG 431 (see chapter 7.3.1) did not justify a classification as Skin Corrosive Category 1, a justification as Skin Irritant Category in accordance with UN GHS is justified. - Executive summary:
The mean OD of the negative controltissues is 1.273 which is within the range of ≥0.8 and ≤2.8, hence the tissues were considered as viable after shipping and storing procedures and under specific conditions of use.Certificate of analysis, histology report and images of EpiDerm tissues of lot No. 33783 provided by MatTekwas provided as Annexures 3, 4 and 5 respectively. Percentage viability of tissues was measured by performing MTT assay after 60 minutes of treatment and post incubation of 43 hours and 7 minutes.The mean percentage viability of test item treated tissues was 45.7 which were <50% of the negative control, hence the test item is considered as irritantand the mean percentage viability of positive controltreated tissues was 4.4 which were <50% of the negative control clearly represents the irritation potential of positive control.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 December 2021 to 08 June 2022
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 431
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP Certificate
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek in vitro Life Science Laboratories
- Justification for test system used:
- The Reconstructed Human Epidermal Model EpiDerm™ (EPI-200-SCT) was selected as test system to assess the skin corrosion potential of the test item as it represents a recommended in vitro test system according to OECD Guideline No. 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- OECD 431
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of two replicates for 3 min exposure
- Value:
- 100.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 2 replicates of 1 h exposure
- Value:
- 89.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results obtained under the conditions of this study, the test item is considered as non-corrosive in accordance with UN GHS, as the mean percentage tissue viability was greater than 50% after 3 minutes exposure and greater than 15% after 1 hour exposure of the negative control.
- Executive summary:
The mean OD of the negative control tissues was 2.537 (3 minutes exposure) and 2.208 (1 hour exposure) which was within the range of ≥0.8 and ≤2.8, hence the tissues were considered as viable after shipping and storing procedures and under specific conditions of use. Percentage viability of tissues was measured by performing MTT assay after 3 minutes and 1 hourof treatment. The mean percentage viability of test item treated tissues was 100.0% after 3 minutes of exposure which were >50% and 100.0% after 1 hour of exposure which were >15% of the negative control hence the test item is considered as non-corrosive.The mean percentage viability of positive controltreated tissues was 2.5% after 3 minutes and 2.1% after 1 hour exposure which were <15% of the negative control clearly represents the irritation potential of positive control.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 December 2020 to 04 January 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Since results of an ex vivo study on eye irritation indicated equivocal results and no stand-alone prediction can be made, a subsequent in vivo study was needed to fulfill the data requirements.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (Section 4: Health Effects), “Acute Eye Irritation/Corrosion” adopted on 09 October 2017 (Corrected on 26 June 2020)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 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) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Adita Biosys Private Limited
- Age at study initiation: 4 months
- Weight at study initiation: 2.39066 kg to 2.42196 kg
- Housing: stainless steel wire mesh cage L 24 x B 18 x H 18 inches
- Diet (e.g. ad libitum): Altromin Maintenance diet for rabbits – Rich in crude fibre 2123
- Water (e.g. ad libitum): Deep bore-well water passed through reverse osmosis unit
- Acclimation period: Start: 21 December 2020 End: 31 December 2020
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3°C to 22.8°C
- Humidity (%): 47% to 67%
- 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: 26 December 2020 To: 04 January 2021 - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): Initial test: 45.2 mg and Confirmatory test: 47.6 mg and 49.1 mg
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48 and 72 hour
- Number of animals or in vitro replicates:
- 3 (1 for initial test, 2 for confirmatory test)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eye was rinsed using 0.9% w/v normal saline after 1 hour treatment (post treatment)
- Time after start of exposure: 1 hour post test item instillation
SCORING SYSTEM: Cornea, area of cornea involved, iris, conjuctivae and chemoses was scored after 1, 24, 48 and 72 hour post test item instillation all with a maximum score of 4
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Other effects:
- - Lesions and clinical observations: No clinical signs of toxicity and mortality were observed in both initial and confirmatory test animals
In both initial and confirmatory test, treated eye (left) revealed occular lesions like redness [Some blood vessels hyperaemic (injected)] at 1, 24 and 48 hour observation and chemosis (Some swelling above normal) at 24 hour observation. The observed lesion reversed back to normal by 72 hour observation
In both initial and confirmatory test, ocular lesion like conjunctivitis were observed at 24 and 48 hour observation. No ocular lesion was observed at 72 hour observation during slit lamp examination
- Effects of rinsing or washing: no effects on the eye due to washing - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the above results of the experiment and under the experimental conditions employed, it is concluded that the mean score of the test item does not meet classification criteria and hence not classified or categorized as per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
The test item was evaluated for Acute Eye Irritation/Corrosion in New Zealand White Rabbits.
The study was performed in two phases i.e., initial and confirmatory tests. Both the eyes of each experimental animal was examined within 24 hours before the treatment. The animals with absence of signs of eye irritation, ocular defects or pre-existing corneal injury were used for the treatment. The pH of test item was 3.08 as per in-house pH determination.
The initial test was conducted using single male rabbit and confirmatory test was conducted using two male rabbits. The systemic analgesic (tramadol hydrochloride injection 2.5 mg/kg) and two drops of topical ocular anaesthetic (0.5% tetracaine hydrochloride) were given to each animal sixty minutes and five minutes prior to test item instillation respectively. The 0.1 mL (Initial test: 45.2 mg and Confirmatory test: 47.6 mg and 49.1 mg) of test item was instilled into the conjunctival sac of the left eye and right eye served as control. The eyes were scored approximately at 1, 24, 48 and 72 hours. Slit lamp examination was carried out using fluorescein strips (fluorescein sodium ophthalmic strip USP) and were scored approximately at 24, 48 and 72 hours for both initial and confirmatory test.
All the animals (initial test and confirmatory test) were observed twice daily for clinical signs of toxicity and mortality. No treatment related clinical signs of toxicity and mortality were observed in all the animals (initial and confirmatory tests) after the test item instillation.
In both initial and confirmatory test, treated eye (left) revealed occular lesions like redness at 1, 24 and 48 hour; chemosis at 24 hour observation. The observed lesion reversed back to normal by 72 hour observation.
In both initial and confirmatory test, ocular lesion like conjunctivitis were observed at 24 and 48 hour observation. No ocular lesion was observed at 72 hour observation during slit lamp examination.
The body weight was recorded on the day of receipt, on the day of treatment (prior to instillation of test item) and at termination of the experiment. No changes were noted in body weight and percent change in body weight with respect to day 1 in both initial and confirmatory test. All the animals revealed physiologically normal increase in body weight in both initial and confirmatory tests.
All the animals were sacrificed by intravenous administration of sodium thiopentone and carcass was disposed.
For initial test and confirmatory test, the mean score calculated across 3 scoring times (approximately 24, 48 and 72 hours after test item instillation) for cornea, iris and conjunctival redness and conjunctival chemosis were 0, 0, 0.67 and 0.33 respectively
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 November 2020 to 02 December 2020
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 26 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Study No. BIO-ALT 047, entitled “Bovine Corneal Opacity and Permeability Test of Mo10V3TeNbO42” was performed in compliance with the OECD Principles of Good Laboratory Practice [C(97)186/Final]
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Justification for selection of Test system: Cornea of the cattle is the recommended test system in the guideline.
- Vehicle:
- water
- Remarks:
- Name : Distilled water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- G1 Vehicle Control 750 µL of distilled water -
G2 Positive Control 750 µL of Imidazole 20% w/v
G3 Test Item 750 µL of test item 20% w/v - Duration of treatment / exposure:
- 3 hours and 55 minutes
- Duration of post- treatment incubation (in vitro):
- 3 hours and 55 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- NUMBER OF REPLICATES: 3
SOLVENT CONTROL USED: water
POSITIVE CONTROL USED: Imidazole
APPLICATION DOSE AND EXPOSURE TIME: 20 % w/v, 3 h 55 min
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: with EMEM (with phenol red) until no visual evidence of the test item was apparent. Subsequent washing step with MEM without phenol red
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry at 49 0nm
- Other: Histopathological evaluation
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: IVIS ≤ 3 considered as UN GHS no category. IVIS score, >3 and ≤ 55 considered as equivocal, subsequently testing with any other adequate method needed. IVIS > 55 considered as severe irritant causing serious eye damage and classified as UN GHS category 1 without further testing. - Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean of three replicates
- Value:
- 44.89
- Vehicle controls validity:
- valid
- Remarks:
- Distilled water
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Imidazole
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein leakage
- Remarks:
- Corrected Permeability Value
- Run / experiment:
- Mean of 3 replicates
- Value:
- 0.009
- Vehicle controls validity:
- valid
- Remarks:
- distilled water
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Imidazole
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- histopathological observations
- Run / experiment:
- observations in thrre replicates
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The results indicated an increase in the endpoint “opacity” but not “permeability”. As the test item resulted in IVIS >3; ≤ 55, it is considered as equivocal and classified as UN GHS no stand-alone prediction can be made. Hence, further testing is needed.
- SUMMARY OF IN VITRO OPACITY SCORE
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- With in the Bovine Corneal Opacity and Permeability Test, the test item induced an IVIS of 44.8 after 3 hours and 55 minutes of treatment. The results indicated an increase in the endpoint “opacity” but not “permeability”. As the test item resulted in IVIS >3; ≤ 55, it is considered as equivocal and classified as UN GHS no stand-alone prediction can be made.
- Conclusions:
- Based on the results obtained in the Bovine Corneal Opacity and Permeability Test, the test item induced an IVIS of 44.8 after 3 hours and 55 minutes of treatment. The results indicated an increase in the endpoint “opacity” but not “permeability”. As the test item resulted in IVIS >3; ≤ 55, it is considered as equivocal and classified as UN GHS no stand-alone prediction can be made
- Executive summary:
Summary
The test item was evaluated for ocular corrosivity or severe irritancy in Bovine cornea.
Eyes of cattle were collected from slaughter house ad eye balls free of defects were selected for the experiment. Empty cornea holder’s opacity was measured and the mean opacity value obtained was determined as I0. Cornea holders with selected Corneas were equilibrated at 32±1ºC for 1 hour and baseline opacity was recorded for each cornea. Corneas with opacity units less than 7 were selected and used for the study.
Quantity of 750 µL 20% w/v of test item, distilled water (vehicle control) and 20% w/v imidazole (positive control) was introduced into anterior chamber in triplicates to the designated cornea holders and incubated at 32±1ºC for 3 hours and 55 minutes. Opacity was measured with the aid of opacitometer and permeability was determined spectrophotometrically at 490 nm (OD490).
The mean corrected opacity and mean corrected permeability values of test item are 44.89 and -0.009 respectively. The in vitro Irritancy Score (IVIS) of test item resulted in 44.8 considered as equivocal, no stand-alone prediction can be made.
The mean corrected opacity and mean corrected permeability values of positive control are 120.34 and 1.573 respectively. The in vitro Irritancy Score (IVIS) of positive control resulted in 143.9, indicating corrosivity or severe irritancy to Bovine corneas.
Referenceopen allclose all
TABLE 1. INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Phase of the Experiment |
Dose (mL/animal) |
Animal No. |
Sex |
Clinical Signs of Toxicity and Mortality on Day |
||||||
1 |
2 |
3 |
4 |
|||||||
# |
* |
# |
* |
# |
* |
# |
||||
Initial Test |
0.1 |
Nb5987 |
M |
N |
N |
N |
N |
N |
N |
N |
Confirmatory Test |
0.1 |
Nb5988 |
M |
N |
N |
N |
N |
N |
N |
N |
0.1 |
Nb5989 |
M |
N |
N |
N |
N |
N |
N |
N |
M: Male; N: Normal; #: First observation; *: Second observation
TABLE 2. INDIVIDUAL ANIMAL EYE IRRITATION/CORROSION SCORING RECORD
Chemosis |
Opacity |
Area |
||||||||||||||||||||||||||||||||||||||||
Eyes |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
||||||||||||||||||||||||||||||||
1 hr |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
||||||||||||||||||||||||||||||||
24 hrs |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
- |
- |
||||||||||||||||||||||||||||||||
48 hrs |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
||||||||||||||||||||||||||||||||
72 hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
||||||||||||||||||||||||||||||||
Mean Tissue Score |
0.67 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
- |
- |
||||||||||||||||||||||||||||||||
|
hr: hour; hrs: hours; LE: Left Eye (Treated Eye); RE: Right Eye (Untreated/Reference control Eye);
Mean Tissue Score = (24 hr+48 hr+72 hr)/3
Redness: 0: Normal; 1: Some blood vessels hyperaemic (injected)
Chemosis:0: Normal; 1: Some swelling above normal
Iris:0: Normal
Opacity:0: No ulceration or opacity
TABLE 2 (Contd...). INDIVIDUAL ANIMAL EYE IRRITATION/CORROSION SCORING RECORD
Confirmatory Test Sex: Male Dose: 0.1 mL/animal Animal No.:Nb5988 |
||||||||||
Observation Period |
Ocular Lesions |
|||||||||
Conjunctiva |
Iris |
Cornea |
||||||||
Redness |
Chemosis |
Opacity |
Area |
|||||||
Eyes |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
1 hr |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
24 hrs |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
- |
- |
48 hrs |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
72 hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
Mean Tissue Score |
0.67 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
- |
- |
Confirmatory Test Sex: Male Dose: 0.1 mL/animal Animal No.:Nb5989 |
||||||||||
Observation Period |
Ocular Lesions |
|||||||||
Conjunctiva |
Iris |
Cornea |
||||||||
Redness |
Chemosis |
Opacity |
Area |
|||||||
Eyes |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
1 hr |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
24 hrs |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
- |
- |
48 hrs |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
72 hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
Mean Tissue Score |
0.67 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
- |
- |
hr: hour; hrs: hours; LE: Left Eye (Treated Eye); RE: Right Eye (Untreated/Reference control Eye)
Mean Tissue Score = (24 hr+48 hr+72 hr)/3
Redness: 0: Normal; 1: Some blood vessels hyperaemic (injected)
Chemosis:0: Normal; 1: Some swelling above normal
Iris:0: Normal
Opacity:0: No ulceration or opacity
TABLE 3. INDIVIDUAL ANIMAL SLIT LAMP EXAMINATION RECORD
Initial Test Sex: Male Dose: 0.1 mL/animal Animal No.: Nb5987 |
||||||
|
Day 2 (24 hours) |
Day 3 (48 hours) |
Day 4 (72 hours) |
|||
Eye |
LE |
RE |
LE |
RE |
LE |
RE |
Lids |
13 |
N |
13 |
N |
N |
N |
Ducts |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
Pupil |
N |
N |
N |
N |
N |
N |
Sclera |
N |
N |
N |
N |
N |
N |
Ciliary Bodies |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
LE: Left Eye; RE: Right Eye; N: Normal/No Abnormality Detected; 13: Conjunctivitis
TABLE 3 (Contd…). INDIVIDUAL ANIMAL SLIT LAMP EXAMINATION RECORD
Confirmatory Test Sex: Male Dose: 0.1 mL/animal Animal No.: Nb5988 |
||||||
|
Day 2 (24 hours) |
Day 3 (48 hours) |
Day 4 (72 hours) |
|||
Eye |
LE |
RE |
LE |
RE |
LE |
RE |
Lids |
13 |
N |
13 |
N |
N |
N |
Ducts |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
Pupil |
N |
N |
N |
N |
N |
N |
Sclera |
N |
N |
N |
N |
N |
N |
Ciliary Bodies |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
Confirmatory Test Sex: Male Dose: 0.1 mL/animal Animal No.: Nb5989 |
||||||
|
Day 2 (24 hours) |
Day 3 (48 hours) |
Day 4 (72 hours) |
|||
Eye |
LE |
RE |
LE |
RE |
LE |
RE |
Lids |
13 |
N |
13 |
N |
N |
N |
Ducts |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
Pupil |
N |
N |
N |
N |
N |
N |
Sclera |
N |
N |
N |
N |
N |
N |
Ciliary Bodies |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
LE: Left Eye; RE: Right Eye; N: Normal/No Abnormality Detected; 13: Conjunctivitis
TABLE 4. INDIVIDUAL ANIMAL BODY WEIGHT (kg) AND PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1
Phase of the Experiment
|
Dose (mL/animal) |
Animal No. |
Sex |
Body Weight (kg) on Day |
Percent Change in Body Weight with Respect to Day |
|
1 |
4 |
1 to 4 |
||||
Initial Test |
0.1 |
Nb5987 |
Male |
2.47619 |
2.51406 |
1.52937 |
Confirmatory Test |
0.1 |
Nb5988 |
Male |
2.49617 |
2.52473 |
1.14415 |
0.1 |
Nb5989 |
Male |
2.51403 |
2.54009 |
1.03658 |
|
|
|
|
Mean |
2.50510 |
2.53241 |
1.09037 |
|
|
|
±SD |
0.01263 |
0.01086 |
0.07606 |
|
|
|
n |
2 |
2 |
2 |
SD: Standard deviation; n: Number of animals
Refer Appendix - 2, 3 & 4
Group & Treatment | Initial Opacity Reading (I) | Opacitometer Reading (After Treatment) | Change in Opacity Value | Corrected Opacity Value | Average of Permeability Value | Corrected Permeability Value | Individual IVIS Value | Mean of Corrected Opacity Value | Corrected Permeability Value | IVIS Value |
G1 & Vehicle Control | 6.073 | 6.164 | 0.091 | 1.094 | 0.060 | 0.061 | - | - | - | - |
6.256 | 6.905 | 0.649 | 0.062 | |||||||
6.119 | 8.662 | 2.543 | 0.061 | |||||||
G2 & Positive Control | 6.301 | 132.116 | 125.815 | 124.720 | 1.636 | 1.575 | 148.3 | 120.34 | 1.573 | 143.9 |
5.983 | 113.696 | 107.713 | 106.619 | 1.634 | 1.573 | 130.2 | ||||
5.983 | 136.752 | 130.769 | 129.675 | 1.632 | 1.571 | 153.2 | ||||
G3 &Test Item | 6.439 | 48.667 | 42.228 | 41.133 | 0.051 | -0.010 | 41.0 | 44.89 | -0.009 | 44.8 |
6.717 | 52.204 | 45.487 | 44.393 | 0.053 | -0.008 | 44.3 | ||||
6.393 | 56.641 | 50.248 | 49.153 | 0.052 | -0.009 | 49.0 |
IVIS: In Vitro Irritancy Score.
Note:
Change in Opacity Value = Opacity reading (after treatment) - initial opacity reading (I).
Corrected Opacity Value = Change in opacity value of positive/test item – mean change in opacity value of vehicle control.
Corrected Permeability Value = Average of permeability value of positive/test item - mean Average of permeability value of vehicle control.
Initial Reading of Empty Cornea Holder with Media
Cornea Holder No. | Opacitometer I0 Value | Mean I0 Value | |||
1 | 1134 | 1145 | |||
2 | 1180 | ||||
4 | 1174 | ||||
5 | 1105 | ||||
6 | 1167 | ||||
7 | 1168 | ||||
8 | 1177 | ||||
9 | 1204 | ||||
10 | 1168 | ||||
12 | 1189 | ||||
14 | 1108 | ||||
15 | 1192 | ||||
17 | 1094 | ||||
18 | 1010 | ||||
20 | 1109 | ||||
Opacity Reading (Before Treatment) | |||||
Corneal Holder No. | Initial Opacitometer Reading (I) | Opacity=I0/I | Opacity Value [= (I0/I-b)/a] | ||
1 | 998 | 1.148 | 6.3 | ||
2 | 1005 | 1.140 | 6.0 | ||
4 | 854 | 1.341 | 14.0 | ||
5 | 742 | 1.543 | 22.1 | ||
6 | 1002 | 1.143 | 6.1 | ||
7 | 995 | 1.151 | 6.4 | ||
8 | 586 | 1.954 | 38.4 | ||
9 | 989 | 1.158 | 6.7 | ||
10 | 698 | 1.641 | 26.0 | ||
12 | 1003 | 1.142 | 6.1 | ||
14 | 657 | 1.743 | 30.0 | ||
15 | 996 | 1.150 | 6.4 | ||
17 | 1005 | 1.140 | 6.0 | ||
18 | 999 | 1.146 | 6.3 |
a=0.0251, b=0.9894, I0=1145
Group & Treatment | Corneal Holder No. | Opacitometer Reading (After Treatment) | Opacity=I0/I | Opacity Value (= (I0/I-b)/a) | Mean Opacity Value |
G1 & Vehicle Control | 12 | 1001 | 1.144 | 6.164 | 7.24 |
18 | 985 | 1.163 | 6.905 | ||
6 | 949 | 1.207 | 8.662 | ||
G2 & Positive Control | 1 | 266 | 4.306 | 132.116 | 127.52 |
2 | 298 | 3.843 | 113.696 | ||
17 | 259 | 4.422 | 136.752 | ||
G3 &Test Item | 7 | 518 | 2.211 | 48.667 | 52.50 |
9 | 498 | 2.300 | 52.204 | ||
15 | 475 | 2.411 | 56.641 |
I0=1145 a=0.0251, b=0.9894
Group & Treatment | Replicate | Permeability OD490 value | Average Permeability | ||
G1 & Vehicle Control | R1 | 0.059 | 0.062 | 0.060 | 0.060 |
R2 | 0.061 | 0.061 | 0.064 | 0.062 | |
R3 | 0.062 | 0.059 | 0.062 | 0.061 | |
G2 & Positive Control | R1 | 1.632 | 1.628 | 1.648 | 1.636 |
R2 | 1.638 | 1.632 | 1.633 | 1.634 | |
R3 | 1.636 | 1.638 | 1.623 | 1.632 | |
G3 & Test Item | R1 | 0.050 | 0.052 | 0.052 | 0.051 |
R2 | 0.053 | 0.054 | 0.051 | 0.053 | |
R3 | 0.053 | 0.052 | 0.052 | 0.052 |
R=Replicates, IVIS= Mean opacity Value + (15×Mean Permeability OD490 value)
Group | Group Description (Treatment) | Corneal Holder No. | Observations | |
G1 | Vehicle Control (Distilled water) | 6 | NAD | |
12 | NAD | |||
18 | NAD | |||
G2 | Positive Control (Imidazole) | 1 | Epithelium:
| · Epithelial cell loss, Squamous layer, mf, 3 · Cytoplasmic coagulation, Squamous and Wing layer, diffuse, 4 · Cytoplasmic vacuolization, Wing and basal layer, diffuse, 3 |
Stroma: | · Collagen matrix expansion, upper stroma, mf, 2 | |||
Endothelium: | · NAD | |||
2 | Epithelium:
| · Epithelial cell loss, Squamous layer, mf, 3 · Cytoplasmic coagulation, Squamous and Wing layer, diffuse, 4 · Cytoplasmic vacuolization, Wing and basal layer, diffuse, 3 | ||
Stroma: | · Collagen matrix expansion, upper stroma, mf, 2 | |||
Endothelium: | · NAD | |||
17 | Epithelium:
| · Epithelial cell loss, Squamous layer, mf, 3 · Cytoplasmic coagulation, Squamous and Wing layer, diffuse, 4 · Cytoplasmic vacuolization, Wing and basal layer, diffuse, 3 | ||
Stroma: | · Collagen matrix expansion, upper stroma, mf, 2 | |||
Endothelium: | · NAD | |||
G3 | Test Item (Mo10V3TeNbO42) | 07 | NAD | |
09 | NAD | |||
15 | NAD |
NAD: No abnormalities detected, mf: Multifocal, 2: Mild, 3: Moderate; 4: Marked.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The OECD TG 431 revealed a mean percentage of viability of 100 % after 3 minutes and 1 hour.
In conclusion, the combination of both OECD TG studies identified the test material as skin irritant category 2.
In regard of eye irritation, OECD TG 437 induced an ICIS of 44.8 after 3 h 55 min, The results indicated an increase in the endpoint "opacity" but not "permeability". As the test item resulted in IVIS > 3 <= 55, it is considered as equivocal and classification according to GHS got not be made as stand alone assay. Hence, a OECD TG 405 was performed. Within this study, both inital and confirmatory test revealed iccular lesions like redness at 1, 24 and 48 h as well as chemosis at 24 h. All effects were reversible after 72 h. Further, noth tests revealed ocular lesion like conjuctivitis at 24 and 48 h, which was reversible after 72 h as well. All in all the mean scoring for cornea, iris and conjuctival redness as well as conjuctival chemosis were 0, 0, 0.67, and 0.33 respectively. Due to the low degree of scores and reversible effects, no classification according to GHS is justified.
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