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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
Eye irritation
Administrative data
- 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.
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 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)
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 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)
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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
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