Registration Dossier
Registration Dossier
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EC number: 232-151-5 | CAS number: 7789-23-3
Endpoint summary
Administrative data
Description of key information
Fluoride salts are not considered irritants to the skin based on results of rabbit skin but are considered irritants to the eye based on a primary eye irritation test.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test parameters evaluated in this study are well documented and scientifically acceptable. The study was conducted according to Good Laboratory Practice regulations.
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Federal Regulations, Title 49, Transportation Revised Oct. 1, 1979, Appendix A - Method of Testing Corrosion to Skin.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm, Belvidere, NJ
- Age at study initiation: 10-12 weeks
- Housing: individually in suspended stainless steel wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow 5321 from W.F. Fisher & Son; at libitum except while dosing and observing
- Water (e.g. ad libitum): tap water adlibitum except while dosing and observing
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 4
- Humidity (%): 50 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved 1 day before dosing
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each test animal received a concurrent negative control patch
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- At 4 hours, immediately after patch removal and again at 48 hours (44 hours after patch removal)
- Number of animals:
- six
- Details on study design:
- TEST SITE
- Area of exposure: 1 X 1 inch square area under a 1 X 1 inch square guaze patch
- Type of wrap if used: Gauze patches wese secured to the skin with Blenderm surgical tape on all 4 edges, then impervious material (Saran Wrap) was used to occlude the patch sites
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize technique for evaluation of skin reactions - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 and 48 hours
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 and 48 hours
- Score:
- ca. 0
- Max. score:
- 0
- Irritant / corrosive response data:
- At 4 and 48 hours after exposure to potassium bifluoride, Draize scores of 0 for erythema and 0 for edema were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information No signs of corrosion or skin irritation (erythema and/or edema). Criteria used for interpretation of results: EU
- Conclusions:
- No signs of skin corrosion or skin irritation (erythema and/or edema) were observed after topical (occluded) exposure to potassium bifluoride for 4-hours.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 - 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. - 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.
- 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
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In rabbits (Allied Corp., 1983), no signs of skin corrosion or skin irritation (erythema and/or edema) were observed after a 4 -hour topical (occluded) exposure to potassium bifluoride. The skin was observed and scored for signs of irritation/corrosion immediately after patch removal and again at 48 hours after patch removal.
In a rabbit eye irritation test (Proctor & Gamble, 1971), in which an undiluted liquid test material containing 1% phosphate (as sodium phosphate) and 100 ppm fluoride (as sodium fluoride) was applied to the eyes, very mild irritaiton (slight conjunctivitis) was produced in two of three test eyes 1 hour after dosing. No signs of irritation were visible 24 hours later; the eye irritation was fully reversible.
In a rabbit eye irritation test (Wnorowski, 1995), 0.1 gram of Composite NaF was instilled in the right eye of each rabbit. The left eye remained untreated and served as a control. 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. Irritation cleared from five of six unwashed eyes but persistent in one animal through day 21.
Effects on eye irritation: corrosive
Justification for classification or non-classification
Based on the skin irritation test, classification is not required for Potassium fluoride.
Based on the results of the primary eye irritation test, and according to the CLP regulation (EC) 1272 -2008, Potassium fluoride is classified as: - Eye damage category 1
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