Potassium tetrafluoroaluminate

Skin irritation / corrosion

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: Non-GLP, non-guideline, some restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test material was applied to the skin of three male and three female rabbits on two sites (one abraded, one unabraded) for 24 hours. Thirty minutes after removal and at 72 hours, dermal irritation was assessed (Draize score).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum potassium fluoride

EC Number:

262-153-1

EC Name:

Aluminum potassium fluoride

Cas Number:

60304-36-1

Details on test material:

Nocolok 100 FLUX (AT-1-KC)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver PA
- Age at study initiation: 14 weeks
- Housing: individually in screen-bottom cages
- Diet: ad libitum, Teklad Laboratory Rabbit diet
- Water: ad libitum
- Acclimation period: at least 7 days

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and unabraded (hair was clipped)

Vehicle:

other: test material was moistened with 0.9% saline

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per site, 2 sites per animal

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3 males, 3 females

Details on study design:

TEST SITE
- Just before the test material was applied, crisscross epidermal abrasions were made on one exposed area of each rabbit to provide one abraded and one intact test site. (Abrasions were sufficiently deep to penetrate the stratum corneum, but not deep enough to penetrate to the dermal layer and cause bleeding).
- Type of wrap if used: 5.0 x 5.0 cm gauze patch secrued wtih paper tape and overwrapped with Saran Wrap and Elastoplast tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test sites washed with tap water and disposable paper towels
- Time after start of exposure: 24 hours

SCORING SYSTEM: at 24 hours and 72 hours, according to Draize technique. Primary dermal irritation index: the sum of the 24 and 72-hour primary dermal irritation scores, divided by two and rounded to the nearest tenth.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 hrs

Score:

0.2

Reversibility:

fully reversible within: 72 hrs

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hrs

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 72 hrs

Score:

0

Max. score:

4

Remarks on result:

other: intact site

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hrs

Score:

0

Max. score:

4

Remarks on result:

other: intact site

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 72 hrs

Score:

0.08

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: abraded site

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hrs

Score:

0.08

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: abraded site

Irritant / corrosive response data:

The test material is not a primary skin irritant.