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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 and 48 hours
Score:
ca. 0
Max. score:
4
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.