Registration Dossier
Registration Dossier
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EC number: 241-022-2 | CAS number: 16949-65-8
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Magnesium hexafluorosilicate hexahydrate
- Cas Number:
- 18972-56-0
- Molecular formula:
- MgSiF6·6H2O
- IUPAC Name:
- Magnesium hexafluorosilicate hexahydrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA
- Weight at study initiation: 185 +/- 15 g
- Diet: Herilan MRH
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 ºC
- Humidity (%): 55 +/- 5 %
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION/ TEST ATMOSPHERE
- Exposure apparatus: cascaded impinger and downstream frits bottle
- Method of holding animals in test chamber: The animals sit in tubes with their snouts in the inhalation space
- Place of sampling: in the immediate vicinity of the animal noses
- Brief description of analytical method used: Titrimetric determination of magnesium - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- ca. 4 h
- Concentrations:
- Concentrations (mg/l) (5 dosis-groups):
nominal: 9.92, 7.85, 7.44, 4.81, 1.18
analytical: 6.06, 5.86, 4.16, 3.15, 1.07 - No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 3.6 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 14.4 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- ca. 3.9 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- ca. 3.4 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- ca. 15.6 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- ca. 13.6 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- Dosis-group 1 (analytical concentration 6,06 mg/l) mortality (dead/exposed): 9/10 (male), 10/10 (female)
Dosis-group 2 (analytical concentration 5,86 mg/l) mortality (dead/exposed): 5/10 (male), 3/10 (female)
Dosis-group 3 (analytical concentration 4,16 mg/l) mortality (dead/exposed): 8/10 (male), 9/10 (female)
Dosis-group 4 (analytical concentration 3,15 mg/l) mortality (dead/exposed): 3/10 (male), 5/10 (female)
Dosis-group 5 (analytical concentration 1m07 mg/l) mortality (dead/exposed): 0/10 (male), 0/10 (female) - Clinical signs:
- other: Dosis-group 1-4: watery or red eyes, and nasal discharge, dyspnoea, tremor (group 1), staggering gait, crouch, apathy (group 1, 3); shaggy and glued fur. Dosis-group 5: watery eye discharge, reddish nasal discharge, subsequently reddish encrusted noses
- Body weight:
- Group 1
Before trial: 185 g (male, number of animals: 10), 181 g (female, number of animals: 10)
After 7 days: 117 g (male, number of animals: 1), -
After 14 days: 146 g (male, number of animals: 1), -
Group 2
Before trial: 186 g (male, number of animals: 10), 188 g (female, number of animals: 10)
After 7 days: 163 g (male, number of animals: 5), 195 g (male, number of animals: 7)
After 14 days: 215 g (male, number of animals: 5), 212 g (male, number of animals: 7)
Group 3
Before trial: 174 g (male, number of animals: 10), 185 g (female, number of animals: 10)
After 7 days: 173 g (male, number of animals: 2), 189 g (male, number of animals: 1)
After 14 days: 243 g (male, number of animals: 2), 224 g (male, number of animals: 1)
Group 4
Before trial: 191 g (male, number of animals: 10), 188 g (female, number of animals: 10)
After 7 days: 209 g (male, number of animals: 7), 190 g (male, number of animals: 5)
After 14 days: 263 g (male, number of animals: 7), 208 g (male, number of animals: 5)
Group 5
Before trial: 187 g (male, number of animals: 10), 183 g (female, number of animals: 10)
After 7 days: 234 g (male, number of animals: 10), 204 g (male, number of animals: 10)
After 14 days: 292 g (male, number of animals: 10), 219 g (male, number of animals: 10)
Control Group
Before trial: 183 g (male, number of animals: 10), 182 g (female, number of animals: 10)
After 7 days: 231 g (male, number of animals: 10), 199 g (male, number of animals: 10)
After 14 days: 274 g (male, number of animals: 10), 214 g (male, number of animals: 10) - Gross pathology:
- Heart: acute dilation or acute hyperaemia; lung: multiple patchy blood and wealth edemous, multiple acute flatulence center of learning degree.
- Other findings:
- Organ o. B.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information harmful if inhaled Criteria used for interpretation of results: EU
- Conclusions:
- harmful if inhaled
- Executive summary:
In an in vivo test, the acute inhalation effects in rats of Magnesium Hexafluorosilicate Hexahydrated were studied according to a dynamic head-nose inhalation method with an analytical and nominal determination of exposure concentration (aerosol exposition). The animals were Sprague-Dawley rats divided in five dose groups (10 male / 10 female for each dose), the body weight of the rats was 185±15 g.
The results showed a LC50 (4 hours) for male and female of 3,6 mg/L of air and a LC50 (1 hour) for male and female of 14,4 mg/L of air.
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