Registration Dossier
Registration Dossier
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EC number: 233-071-3 | CAS number: 10028-18-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 16,2008 to December 3,2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Nickel fluoride tetrahydrate
- IUPAC Name:
- Nickel fluoride tetrahydrate
- Details on test material:
- - Name of test material (as cited in study report):nickel (II) fluoride tetrahydrate Code #N111-PTL
- Physical state: Yellow green powder
- Analytical purity:99%
- Solubility: 2.51 g/100g (water)
Test substance was expected to be stable for the duration of testing
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson services Inc
- Age at study initiation: young adult
- Housing: The animals were housed in suspended stainless steel caging with meshfloors, which conform to the size recomnmendation in the recent "guide for care and Use of laboratory animals DHEW (NIH).Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (ad libitum): Pelleted Purina rabbit chow #5326
- Water (ad libitum): Filtered tap water
- Acclimation period :14 days
-Contaminants: There were no known contaminants reasonably expected to be found in the food or water at level which woul have interfered with the results of this study.Analyses of the food and water are inconducted regularly and the records are kept on file at Eurofins Product and Safety Laboratories.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 69-84
Test system
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): one tenth of a milliliter (0.09g of test substance) - Duration of treatment / exposure:
- Ocular irritation was evalueted using a high-intensity , white light (Maglite) in accordance with Draize method at 1, 24 , 48, 72 hours and at 4, 7 , 10 , 1417 and 21 days post instillation.
- Observation period (in vivo):
- 21 days after the instillation.
- Number of animals or in vitro replicates:
- 3 female rabbit New zeland albino.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- >= 36 - <= 41
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 43 - <= 65
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 43 - <= 65
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 43 - <= 65
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- >= 28 - <= 65
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- >= 26 - <= 63
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 10 days
- Score:
- >= 26 - <= 63
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- >= 24 - <= 61
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 17 days
- Score:
- >= 24 - <= 61
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 21 days
- Score:
- >= 24 - <= 59
- Irritant / corrosive response data:
- After test substance instillation, all three treated eyes exhibited corneal opacity, iritis, and "positive" conjunctivis from 24 to 72 hours.The overall incidence and severity of irritation decreased gradually thereafter.Blanching around the eye tissue was noted for all animals from 24 hours to day 21, and a white discharge was noted for two animals from 24 hours to day 21.Ocular irritation persisted for all threee animals through day 21 (study termination).
- Other effects:
- no
Any other information on results incl. tables
All animals appeared active and healthy during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
After test substance instillation, all three treated eyes exhibited corneal opacity, iritis, and 'positive' conjunctivitis from 24 to 72 hours. The overall incidence and severity of irritation decreased gradually thereafter. Blanching around the eye tissue was noted for all animals from 24 hours to Day 21, and a white discharge was noted for two animals from 24 hours to Day 21.
Ocular irritation persisted for all three animals through Day 21 (study termination).
| Time post | Incidence of positive Effect | ||
| instillation | Corneal Opacity | Iritis | Conjunctivitis |
| 1 hour | 3/3 | 3/3 | 3/3 |
| 24 hours | 3/3 | 3/3 | 3/3 |
| 48 hours | 3/3 | 3/3 | 3/3 |
| 72 hours | 3/3 | 3/3 | 3/3 |
| day 4 | 3/3 | 3/3 | 3/3 |
| day 7 | 3/3 | 3/3 | 3/3 |
| day 10 | 3/3 | 3/3 | 3/3 |
| day 14 | 3/3 | 3/3 | 3/3 |
| day 17 | 3/3 | 3/3 | 3/3 |
| day 21 | 3/3 | 3/3 | 3/3 |
| Time post instillation | Severity of irritation - mean score |
| 1 hour | 39.3 |
| 24 hours | 51.0 |
| 48 hours | 51.0 |
| 72 hours | 51.0 |
| day 4 | 44.3 |
| day 7 | 41.7 |
| day 10 | 41.7 |
| day 14 | 40.3 |
| day 17 | 39.7 |
| day 21 | 39.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Extremely irritating
- Remarks:
- Criteria used for interpretation of results: other: Draized method
- Conclusions:
- The Maximum Mean Total Score of Nickel (II) fluoride tetrahydrate is 51.0.Under the conditions of this study, Nickel fluoride tetrahydrate is classified as extremely irritating to the eye.
- Executive summary:
A primary eye irritation test was conducted with rabbits to determine the potential for Nickel (II) fluoride tetrahydrate to produce irritation from a single instillation via the ocular route. Under the conditions of this study, the test substance is classified as extremely irritating to the eye.
One-tenth of a milliliter (0.09 grams) of the test substance was instilled into the right eye of three healthy rabbits.The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al.
After test substance instillation, all three treated eyes exhibited corneal opacity, iritis, and 'positive' conjunctivitis from 24 to 72 hours, The overall incidence and severity of irritation decreased gradually thereafter, Blanching around the eye tissue was noted for all animals from 24 hours to Day 21, and a white discharge was noted for two animals from 24 hours to Day 21.
Ocular irritation persisted for all three animals through Day 21 (study termination).
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