Potassium hydrogendifluoride

Skin irritation / corrosion

Administrative data

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.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hydrogendifluoride

EC Number:

232-156-2

EC Name:

Potassium hydrogendifluoride

Cas Number:

7789-29-9

Molecular formula:

F2HK

IUPAC Name:

potassium hydrofluoride fluoride

Details on test material:

- Name of test material (as cited in study report): potassium bifluoride
- Physical state: solid
- Analytical purity: Not known
- Stability under test conditions: Stable at room temperature and assumed stable during test period
- Storage condition of test material: Room temperature

Test animals

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

Test system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 and 48 hours

Score:

ca. 0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 and 48 hours

Score:

ca. 0

Max. score:

4

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.

Applicant's summary and conclusion

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.

Executive summary:

Potassium bifluoride – solid substance is not irritating or corrosive with solid. However, the study is not relevant to humans: the test animal (rabbit) does not sweat; humans sweat therefore if solid substance came into contact with damp skin, HF would be generated which is corrosive.