Dihydrogen bis(acetato-O)difluoroborate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test material

Test material information

Constituent 1

Reference substance name:

Dihydrogen bis(acetato-O)difluoroborate(1-)

EC Number:

206-768-5

EC Name:

Dihydrogen bis(acetato-O)difluoroborate(1-)

Cas Number:

373-61-5

Molecular formula:

BF3 x (CH3COOH)2

IUPAC Name:

bis(acetic acid); trifluoroborane

Details on test material:

Name of test substance used in the study report: Borfluorid-Essigsaeure (40%)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animal identification: Ear tattoo
The animals were housed in fully air-conditioned rooms; the central air conditioning guaranteed a range of 20-24°C for temperature and of 30-70% for relative humidity. The day/night rhythm was 12 hours light and 12 hours dark. The animals were held (single housing) in stainless steel wire mesh cages (floor area: 3000 cm2). A standard laboratory diet and tap water were used.
The acclimatization period was at least one week. Weight determination was done shortly before application of the test substance.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: the fur was removed by clipping the dorsal of the trunk of the animals

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

3 min and 1 hour

Observation period:

48 h, 72 h, 15 d

Number of animals:

3 animals (3 min application); 1 animal (1 h application)

Details on study design:

The test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semiocclusive dressning. The test substance was removed at the end of the exposure period with Lutrol(R) and Lutrol(R)/water (1:1).
The test patch (2.5 x 2.5 cm) was moistened with a dose of 0.5 ml of the unchanged liquid test substance.
Application site: upper third of the back or flanks
Readings were done after 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after removal of the patch.
General observations: A check was made twice each working day and once on weekends and on public holidays for general observations and for any dead or moribund animal.
Additional investigation: Because the visual assessment of the skin did not allow a statement with regard to the depth of necrotic changes (full-thickness necrosis), a cross incision of the treated skin has been performed after the animal was killed at study termination. Additionally histopathological examination has been performed in one animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.8

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: 3-min exposure

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 1-h exposure

Irritant / corrosive response data:

3 minutes exposure: A mean value for erythema could not be calculatead, because in one animal visual necrosis was observed 24 hours after removal of the patch. Thus, the observation period for this rabbit was terminated after 72 hours. The macroscopic lesion of the skin was assessed by pathological examination, which revealed superficial necrosis.
The skin findings (such as erythema and edema) were reversible in one animal within 15 days, while erythema was still present in another animal at study termination.
1 hour exposure: Visual necrosis was observed in the animal after removal of the patch. Due to severe corrosion, the observation peroid was terminated after 48 hours. The macroscopic lesion of the skin was assessed by histopathological examination, which revealed severe necrosis from the coagulation type (full-thickness necrosis).

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information