reaction mass of potassium tetrafluoride and tripotassium hexafluoroaluminate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant, non-guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.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:

One group of 5 male and 5 female rats was exposed to 4.92 mg/L of the test substance for 1 hour, followed by an observation period of 14 days.

GLP compliance:

yes

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: 41105734

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Crl:CD (SD) BR
- Source: Charles River Breeding Laboratories, Portage, MI.
- Weight at study initiation: Mean of 233 g (males) and 225 g (females).
- Fasting before study: none
- Housing: individually, cage size conformed to the standards specified in DHEW Publication (NIH) 78.23
- Diet: ad libitum, Purina Certified Rodent Chow 5002, ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): within the range specified in ABC SOP's
- Humidity (%): within the range specified in ABC SOP's
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

1.3 µm

Geometric standard deviation (GSD):

1.58

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Stainless steel and glass inhalation chamber
- Exposure chamber volume: 80
- Method of holding animals in test chamber: cage
- Source and rate of air: 21.1 l/min
- System of generating particulates/aerosols: The aerosol was generated by passing a stream of air through the test article contained in a dust shaker mechanism. The resulting air-dust mixture entered the top center of the inhalation chamber and exhausted at the bottom of the chamber. A stream of additional air was added to the chamber to achieve the desired concentration and to aid in test article dispersion
- Method of particle size determination: Delron cascade impactor, model no. DCI-6
- Treatment of exhaust air: Exhausted test atmosphere was diluted prior to release to the outside atmoshpere via an exhaust blower
- Temperature, humidity, pressure in air chamber: T: 72.3 F; RH: 40.0%; P: -0.10 inches of water

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrical analysis
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- Particle size distribution: 99.8% of the weight of the particles is contributed by particles less than or equal to 10.0 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD: 1.30 µm / GSD: 1.58

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrical analysis

Duration of exposure:

1 h

Concentrations:

4.92 mg/L (gravimetric concentration); 87.2 mg/L (nominal concentration)

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: During exposure: incidence of mortality and reactions displayed every 15 min. Observation period: twice daily mortality checks. Weighing: prior to exposure and on day 14
- Gross necropsy of survivors performed: yes, external surface and body orifices, cervical organs, thoracic organs, abdominal and pelvic organs, and the brain

Results and discussion

Preliminary study:

not performed

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4.92 mg/L air

Exp. duration:

1 h

Mortality:

Four ot the test animals died during the study (1 male, 3 females)

Clinical signs:

other: Irregular breathing, poor coat quality, yellow/brown stained fur, lethargy, crusty eye, crusty nose, and crusty muzzle

Body weight:

The surviving animals exhibited body weight gains during the invenstigational period.
- Males: Day 0: 233.4 g (SD15.9), Day 14: 281.0 g (SD 28.1).
- Females: Day 0 225.0 g (SD 24.9), Day 14: 245.5 g (SD 30.4)

Gross pathology:

Abnormalities of the stomach (multifocal erosions, diffuse red brown discoloration of glandular mucosa), glandular stomach (mucosa smooth and discolored red brown), heart (diffusely pale, tan discoloration, mottling) and small intestine (dark contents) were observed in 2 males and 3 females.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The inhalatory LC50, 4h value of multiconsituent aluminium potassium fluoride in rats was established to be within the range of 1 – 5 mg/L.

Executive summary:

The acute inhalation toxicity of multiconsituent aluminium potassium fluoride in the rat was investigated in a GLP compliant, non-guideline study. Despite some minor restrictions in design and/or reporting, the study is considered as adequate for assessment.

One group of 5 male and 5 female rats was exposed whole body to a dust atmosphere of the test substance. The duration of the exposure was 1 hour followed by a 14 day observation period. The gravimetric concentration of test article in the test atmosphere was 4.92 mg/l. Particle size analysis of the exposure chamber revealed a mass median diameter of 1.30 µm and geometric standard deviation of 1.58.

Four of the test animals died during the study. Irregular breathing, poor coat quality, yellow/brown stained fur, lethargy, crusty eye, crusty nose, and crusty muzzle were observed among the test animals during the study period. Necropsies revealed no gross lesions in 5 of 10 test animals. Abnormalities of the small intestine, stomach, and heart were observed in the remaining test rats. Based on the observed mortality it can be concluded that the 1-hour LC40 of the test substance is 4.92 mg/L which would correspond to a 4-hour LC40 of 1.23 mg/l when applying Haber's rule. The 4 -hour LC50 will be slightly above this concentration.

Based on the above observations, the inhalatory LC50, 4h value of multconstituent aluminium potassium fluoride in rats was established to be within the range of 1 – 5 mg/L and therefore the test substance needs to be classified as Category 4 H332 'Harmful if inhaled' according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.