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Acute Toxicity: inhalation

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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

Constituent 1
Chemical structure
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.