Registration Dossier
Registration Dossier
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EC number: 232-151-5 | CAS number: 7789-23-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- May-June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study comply with the Principles of GLP OECD and was conducted in accordance with EPA OPP 81-4 guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- IUPAC Name:
- sodium fluoride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Composite NaF
- Molecular formula (if other than submission substance): NaF
- Physical state: white powder
- Analytical purity: Technical sodium fluoride 95,6 % (w/w)
- Lot/batch No.: 199-7-4
- Stability under test conditions: Stable
- Storage condition of test material: room temperature
- Date received: April 27, 1995
- Expiration date: Not applicable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ on May 11, 1995
- Age at study initiation: Not indicated (Adult)
- Weight at study initiation: not indicated
- Housing: One animal in one stainless steel cage
- Diet: Pelleted Purina Rodent Chow 5326
- Water: Ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-71
- Humidity (%): Not indicated
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12/12
TEST DATES: From: 24 May 1995 - To: 14 June 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each rabbit served as a control
- Amount / concentration applied:
- 0,1 g
- Duration of treatment / exposure:
- one instillation into the right eye of each rabbit (1 second)
- Observation period (in vivo):
- until day 21 post intillation
- Number of animals or in vitro replicates:
- nine healthy rabbits (6 males and 3 females)
two groups of rabbits: treated eyes of three rabbits were washed with physiological saline after instillation, the eyes of the remaining six rabbits were not washed - Details on study design:
- - Duration of observation period following administration: 21 days
- Frequency of observations : Daily cage-side observations during the test period (gross toxicity, behavioral changes and mortality), ocular observation with a high-intensity white light at 1, 24, 48, 72 hours and 4, 7, 10, 14, 17, and 21 days post-intillation and corneal, iris and conjunctivae damage evaluation with a fluorescein dye evaluation procedure at 24 hours.
- Classification of eye scores: The average 24-hour scores (MMTS) for each group of rabbits (unwashed and washed eyes) was determined to classify the test substance by the system of Kay and Calandra (modified).
- Other examinations performed: observation of tremors, convulsions, salivation, diarrhea, sleep and coma.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48h
- Score:
- 15
- Max. score:
- 80
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: not reversible for one rabbit and reversible from day 21 for another rabbit
- Irritation parameter:
- iris score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks:
- from day 7
- Remarks on result:
- other: not reversible for one rabbit and reversible from day 10 for another one
- Irritation parameter:
- conjunctivae score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48h
- Score:
- 14
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks:
- from day 17
- Remarks on result:
- other: not reversible for one rabbit and reversible from day 21 for another one
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- other: no irritation
- Irritation parameter:
- iris score
- Remarks:
- washed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 1 hour
- Irritation parameter:
- conjunctivae score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Remarks:
- animals 3
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24h
- Irritant / corrosive response data:
- For unwashed eyes rabbits:
Corneal opacity, iritis and conjunctivis were noted for unwashed eyes rabbits after test substance instillation. The severity of irritation increased through 48 hours, then decreased. Irritation cleared from five of six unwashed eyes but persisted in one animal through day 21.
For washed eyes rabbits:
All three washed eyes exhibited iritis and cunjunctivis after one hour of instillation but all animals were free from ocular irritation by 48 hours. No corneal opacity was noted in any of the washed eyes during the study. - Other effects:
- No other effects apart the eye irritation.
Any other information on results incl. tables
Table 1: Synthesis of the raw results
|
The 24 hour Maximum Mean Total Score of Composite NaF is 26,5 and 2,0 for the unwashed and washed eyes, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- other: Severelly irritating to the unwashed eyes rabbits and practically not irritating for washed eyes rabbits.
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Occular irritation was evaluated by the method of Draize et al. The eye scores were further classified by the system of Kay and Calandra. Twenty four hours after test substance instillation, all treated eyes exhibited conjunctivis. All six unwashed eyes also had corneal opacity and iritis. By day 21, irritation cleared from 5 of 6 unwashed eyes, but corneal opacity, iritis and conjunctivis persisted in one animal.
Based on these irreversible effects, ammonium fluoride is classified as causing serious damage to the eyes (category 1). - Executive summary:
A primary eye irritation test was conducted with nine healthy rabbits to determine the potential for composite NaF to produce irritation and/or corrosion via the ocular route. 0,1 gram of the test substance was instilled in the right eye of each rabbit. The treated eyes of three rabbits were washed with physiological saline after instillation, the eyes of the remaining six rabbits were not washed. The left eye served as a control.
Ocular irritation was evaluated by the method of Draize et al. The scores were further classified by the system of Kay and Calandra (MMTS).
For unwashed eyes rabbits:
Corneal opacity, iritis and conjunctivis were noted for unwashed eyes rabbits after test substance instillation. The severity of irritation increased through 48 hours, then decreased. Irritation cleared from five of six unwashed eyes but persisted in one animal through day 21.
For washed eyes rabbits:
All three washed eyes exhibited iritis and cunjunctivis after one hour of instillation but all animals were free from ocular irritation by 48 hours. No corneal opacity was noted in any of the washed eyes during the study.
Based on these results and according to the CLP regulation (EC) 1272 -2008, Ammonium fluoride is classified as:
Eye damage category 1
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