Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 August 2008 - 28 October 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

12 May 1981

Deviations:

yes

Remarks:

"Values for humidity above the target range were occasionally observed. This deviation was considered to have no impact on the study outcome."

GLP compliance:

yes (incl. QA statement)

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fluorphlogopite (Mg3K[AlF2O(SiO3)3])

EC Number:

234-426-5

EC Name:

Fluorphlogopite (Mg3K[AlF2O(SiO3)3])

Cas Number:

12003-38-2

Molecular formula:

AlF2O10Si33Mg

IUPAC Name:

Fluorophlogopite

Test material form:

not specified

Specific details on test material used for the study:

Identification: Art. 278900 (Fluorphlogopite)
Batch number: 080406.
Particle Size: 10 - 40 µm
Expiry Date: 09 May 2013.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, protected from direct sunlight.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanRcc:WIST(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Füllinsdorf, Switzerland.
- Females (if applicable) nulliparous and non-pregnant: Not specified.
- Age at study initiation: Males, 9 weeks; Females, 10 weeks.
- Weight at study initiation: Males, 264.2 - 275.7 g; Females, 207.5 - 224.2 g
- Fasting period before study: Not specified.
- Housing: Groups of max. 5 of the same sex/cage.
- Diet: Standard pelleted diet ad libitum, except during exposure period.
- Water: Tap water ad libitum, except during exposure period.
- Acclimation period: Not specified.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hour photocycle. "A radio program was played during the most of the light period"

IN-LIFE DATES: Not specified. Experimental phase completed 21 Aug 2008 (i.e. animals aged 11 - 12 weeks old)

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

2.44 µm

Geometric standard deviation (GSD):

2.2

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Rotating brush aerosol generator. Broillet, CR 3020 Equipements SA, Tannay, Switzerland.
- Method of holding animals in test chamber: Restraint tubes.
- Method of particle size determination: Cascade impactor.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Remarks on duration:

"Single, 4-hour exposure period with five interruptions for a total of 7 minutes for cleaning purpose. Nevertheless, the animals were exposed for a total of 4 hours, as those interruptions were accounted for."

Concentrations:

5.1 mg/L

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: Clinical signs recorded once daily. Body weights recorded before exposure (day 1), and subsequently on days 4, 8 and 15 (terminal body weight).
- Necropsy of survivors performed: yes
- Other examinations performed: lungs, trachea, larynx and the head containing the nasopharyngeal tissues were collected and fixed for histopathological examination.

Statistics:

"No statistical analysis was performed as only one dose group was allocated to the study."

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

All animals survived the scheduled observation period.

Clinical signs:

other: No clinical signs were recorded during the exposure or observation period.

Body weight:

There were no test item-related changes to body weights or body weight gains reported.

Gross pathology:

There were no macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute inhalation toxicity limit test, the LC50 of fluorphlogopite was determined to be > 5.1 mg/L air.

Executive summary:

The acute inhalation toxicity of fluorphlogopite was investigated in a guideline study, conducted in accordance with GLP. Male and female rats were exposed nose-only for 4 hours to an atmosphere containing the test material at a concentration of 5.1 mg/L air. There were no deaths, no clinical signs of toxicity and no changes to body weight gain during the 14-day observation period. No macroscopic abnormalities were observed at necropsy. The LC50 was therefore concluded to be > 5.1 mg/L air.