Hydrogen trifluoromethoxyborate(1-), compound with methanol (1:1)

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:

Hydrogen trifluoromethoxyborate(1-), compound with methanol (1:1)

EC Number:

220-543-9

EC Name:

Hydrogen trifluoromethoxyborate(1-), compound with methanol (1:1)

Cas Number:

2802-68-8

Molecular formula:

CH4O.CH3BF3O.H

IUPAC Name:

hydrogen trifluoro(methanolato)borate(1-) methanol (1:1)

Details on test material:

Name of the test substance used in the study report: Borfluorid-Methanol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Mean body weight: 4 kg; age: young adult rabbits
The animals were identified via ear tattoo.
Singly housing in stainless steel wire mesh cages with grating (floor area: 3000 cm2).
The animals were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
A standardized animal laboratory diet (a. 130 g/animal/day) as well as tap water (250 ml/animal/day) were offered.
Acclimatization period: at least 1 week
Weight determination: shortly before application of the test substance

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

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 h

Observation period:

3 min application: 8 days
1 h application: 24 h

Number of animals:

3 min application: 3
1 h application: 2

Details on study design:

At least 24 hours before study start, the fur was removed by clipping the dorsal of the trunk of the animals. Only animals with healthy intact skin have been used.
The test substance was applied in a signle dose to the intact untreated skin. The test patches were secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).
Application volume: The test patches (2.5 x 2.5 cm) were moistened with a dose of 0.5 ml of the unchanged liquid test substance.
Application site: upper third of the back or flanks
Observation period: 8 day (3 min application) resp. 72 h (1 h application)
Readings: 1 h, 24 h, 48 h, 72h and 8 d after removal of the test patches.
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 animals.
Additional investigation: Because the visual assessment of the skin did not allow a statement with respect to the depth of necrotic changes, a cross incision of the treated skin has been performed after the animal was killed at study termination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1.2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: 3 min application

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: 3 min application

Irritant / corrosive response data:

After the application of 1 hour the following findings were observed: The average score for irritation could not be calculated because of visual necrosis and therefrom rsulting study termination at 24 hours after removal of the test patchtes.
Visual necrosis was observed 1 hour after removal of the test patches, thus, the observation period was terminated after 24 hours. The necrotic change of the skin was assessd by macroscopic pathology indicating fulll-thickness necrosis.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

Classification: corrosive (causes burns)