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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:
supporting study
Study period:
1992-11-11 to 1992-11-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study reliable with restrictions - The purity and stability of the test substance were not stated. - According to the guideline, the dorsal area on the trunk should be cleared of hair. In this study the dorsal flank was cleared of hair. - According to the guideline, in addition to the observation of irritation, all toxic effects should be fully described and recorded. This was not included in the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, see "Rationale for reliability" above
GLP compliance:
yes (incl. certificate)
Remarks:
signed 1992-06-11

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Potassium tetrafluoroborate
- Physical state: White crystalline solid
- Storage condition of test material: Room temperature
- Container: White plastic jar
No further information on the test substance was stated.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: Twelve to sixteen weeks old
- Weight at study initiation: 2.57 - 2.70 kg (3 animals: 2.70 kg, 2: 2.57 kg, and 2.57 kg, respectively)
- Housing: The animals were individually housed in suspended metal cages.
- Diet (ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K.)
- Water (ad libitum): Mains drinking water
- Acclimation period: Minimum acclimatisation period of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 20 °C
- Relative humidity: 52 - 63%
- Air exchange: approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was applied.
No further nformation on the amount/concentration applied was stated.
Duration of treatment / exposure:
4 hours
Observation period:
Approx. 1, 24, 48 and 72 hours after removal of patches
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
For the purpose of this study the test material was moistened with distilled water immediately before application.
On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by groos observation were selected for the study.
A suitable test site was selected on the back of each rabbit. The test material moistened with distilled water, was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. the patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Four hours after application

SCORING SYSTEM: Draize scoring system
Any other adverse skin reactions, if present, were also recorded.
No further information on the study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No evidence of skin irritation was noted during the study period.
No corrosive effects were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the Directive 67/548/EEC and its subsequent amendments, potassium tetrafluoroborate is non-irritating to the skin.
Also, according to the Regulation (EC) No. 1272/2008 and subsequent amendments, potassium tetrafluoroborate is non-irritatng to the skin.