reaction mass of potassium tetrafluoride and tripotassium hexafluoroaluminate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Five male and five female rabbits were used for a single dermal dosage level of 2.0 g/kg bw and held for an observation period of 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium potassium fluoride

Molecular formula:

KAlF4 and K2AlF5 x H2O

IUPAC Name:

Aluminium potassium fluoride

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Sample number: 41105731

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver PA
- Age at study initiation: 14 weeks
- Weight at study initiation: 2497 - 2891 g
- Housing: screen-bottom cages, individually
- Diet: ad libitum, Teklad Laboratory Rabbit diet
- Water: ad libitum
- Acclimation period: at least 7 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: test material is moistened with 0.9% saline

Details on dermal exposure:

TEST SITE
- Area of exposure: animals' shaved back
- % coverage: shaved area made up approximately 20% of the total body surface
- Type of wrap if used: 4x4-inch gauze patch secured with paper tape and overwrapped with Saran Wrap and Elastoplast tape.
- Just before the test material was applied, longitudinal epidermal abrasions (deep enough to penetrate the stratum corneum, not deep enough to penetrate to the dermal layer and cause bleeding) were made on the exposed back of two male and three female animals.

REMOVAL OF TEST SUBSTANCE
- Backs were wiped clean with wet disposable paper towels.
- Time after start of exposure: 24 hrs

Duration of exposure:

single dose for 24 hrs

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations (dermal irritation, clinical signs and mortality): daily; weighing: just prior to test material application and on day 7 and 14
- Necropsy of survivors performed: no

Statistics:

not reported

Results and discussion

Preliminary study:

not performed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 other: g/kg bw

Mortality:

no mortality

Clinical signs:

other: no clinical signs are reported

Gross pathology:

not reported