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Diss Factsheets

Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug 07 -21, 2008
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 403.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
EC Number:
EC Name:
Fluorphlogopite (Mg3K[AlF2O(SiO3)3])
Cas Number:
Molecular formula:

Test animals

Details on test animals or test system and environmental conditions:
- Source: RCC Ltd, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 9 weeks, Females: 10 weeks
- Weight at study initiation: Males: 264.2 to 275.7 g, Females: 207.5 to 224.2 g
- Fasting period before study: no

- Housing: housed in groups of maximally 5 of the same sex in Makrolon® type-IV cages with wire mesh tops and standard softwood bedding ("Lignocel", Schil AG, 4132 Muttenz, Switzerland).

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

- Temperature (°C): 22 ± 3 °C,
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Route of administration:
Type of inhalation exposure:
nose only
Inhalation by nose-only, flow-past exposure
Details on inhalation exposure:

- Exposure apparatus:
Inhalation exposure was performed using a system similar to that originally described by Sachsse
et al. (1973). The animals were confined separately in restraint tubes which were
positioned radially around the flow-past, nose-only exposure chamber as described by Cannon et
al. (1983). The design of this chamber is based upon the fluid dynamic modeling of the
test aerosol flow.

K. Sachsse, L. Ullmann, G. Voss and R. Hess:
Measurements of Inhalation Toxicity of Aerosols in Small Laboratory Animals. In:
Proceedings of the Europ. Soc. For the Study of Drug Toxicity, 15, 239-251, Zürich,

W.C. Cannon, E.F. Blanton and K.E. McDonald:
The Flow-Past Chamber: An Improved Nose-Only Exposure System for Rodents, Am.
Ind. Hyg. Assoc. J., 44, 923-928, 1983.

- Method of holding animals in test chamber: restraint tubes
- Rate of air: 1.0 L/min
- Method of conditioning air: rotating brush aerosol generator
- System of generating particulates/aerosols: micronising jet mill connected to a rotating brush aerosol generator
- Method of particle size determination: 7 stage cascade Mercer Impactor (Model 02-130, In-Tox. Products Inc., Albuquerque, New Mexico, USA)
- Temperature, humidity, pressure in air chamber: Vaisala HMI 32 recorded each 30 min

- Brief description of analytical method used:
The concentration of the test item determined gravimetrically, the particle size distribution
determined gravimetrically, temperature, relative humidity and oxygen concentration were
measured on test atmosphere samples collected directly from the delivery tube at an empty port
of the exposure chamber, as specified below. The position at which these test atmosphere
samples were taken was considered to be representative for the breathing zone of the animals.
Airflow rates were determined for the recording of temperature, relative humidity and oxygen
concentration and during the collection of samples for the determination of test aerosol
concentration and particle size using a dry-test meter and a pressure gauge, calibrated with a
reference dry-test meter.

- Samples taken from breathing zone: no

TEST ATMOSPHERE (if not tabulated)

- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): median aerodynamic diameter of 2.44 μm with
geometric standard deviations of 2.18 and 2.20
Analytical verification of test atmosphere concentrations:
dry-test meter and a pressure gauge,
Duration of exposure:
4 h
5.1 mg/L
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: days 1 (before exposure), 4, 8 and 15 (before necropsy).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
no statistics (single dose)

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
All animals survived the scheduled observation period.
Clinical signs:
other: No clinical signs were recorded during the exposure or the observation period.
Body weight:
From test day 1 to test day 4, marginal body weight loss was noted in two females. This was
considered to be related to stress caused by the restraint during exposure and not an effect of the
test item. From test day 4 onwards, all animals showed a normal body weight development.
There were no effects on body weight in the remaining animals.
Gross pathology:
There were no macroscopic findings.

Any other information on results incl. tables

Inhalative treatment of HanRcc:WIST(SPF) rats with the test material at a concentration of 5.1 mg/L for 4 hours was well tolerated and did not result in any signs of toxicity.

In conclusion, the LC50 of the test material obtained in this study was estimated to be greater than 5.1 mg/L air (gravimetrically determined mean aerosol concentration).

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
In conclusion, the LC50 of the test material obtained in this study was estimated to be greater than 5.1 mg/L air (gravimetrically determined mean aerosol concentration). Thus there is no need for classification for acute inhalative toxicity according to CLP-Regulation (EC) No 1272/2008.
Executive summary:

Study Design

A group of five male and five female albino rats [HanRcc:WIST(SPF)] was exposed by nose-only, flow-past inhalation to the test item at a gravimetrically determined mean concentration of 5.1 mg/L air (s.d. ± 0.0 mg/L air, n = 4). Two gravimetric measurements of particle size distribution during exposure produced a mass median aerodynamic diameter (MMAD) of 2.44 μm with geometric standard deviations of 2.18 and 2.20. All animals were observed for clinical signs and mortality during the inhalation exposure and the 15-day observation period. Body weights were recorded prior to exposure on test day 1, and during the observation period on test days 4, 8 and 15. On day 15, all animals were killed and necropsied.
The ranges of aerosol concentration, temperature, relative humidity, oxygen content and airflow measured during the exposure were considered to be satisfactory for a study of this type. In addition, the test item aerosol was considered to be appropriate for acute inhalation toxicity testing and respirable to rats.


All animals survived the scheduled observation period.
No clinical signs were recorded during exposure or the observation period.
Transient effects on the body weight were noted in two females between test days 1 and 4 which were considered not to be test item related. From day 4 until the end of the observation period all animals showed a normal body weight gain.
No macroscopic findings were recorded.


In conclusion, the LC50 of the test material obtained in this study was estimated to be greater than 5.1 mg/L air (gravimetrically determined mean aerosol concentration).