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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:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Principles of method if other than guideline:
- Principle of test:
1) Dynamic spray inhalation equipment (NIESSEN et al., 1963)
2) Static spray inhalation
- Short description of test conditions:
1) spraying of test substance mixed with alcohol and lutrol (1:1), absorbent: cotton for absorption of spray mist containing test substance; 3 air concentrations (nominal: 0.25, 0.5, 1, 2.5, 2.5 mg/L, analytical: 0.064, 0.141, 0.296, 0.662, 0.9 mg/L, 5 dose groups), exposure time 4 hours; 2 weeks observation
2) spraying of test substance mixed with alcohol and lutrol (1:1) every 30 min within 4 hours of total exposure; air agitation by use of fan; rabbits, guinea pigs, rats and mice together exposed in respective 2 m³ test chamber; 2 weeks observation

- Parameters analysed / observed:
1) clinical signs; lethal concentration
2) clinical signs
GLP compliance:
no
Remarks:
study conducted prior to implementation of GLP
Test type:
traditional method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
EC Number:
233-487-5
EC Name:
2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
Cas Number:
10196-49-3
Molecular formula:
C6H15NOSi
IUPAC Name:
2,2,4-trimethyl-1,4,2-oxazasilinane
Test material form:
liquid
Details on test material:
Batch number: 20140202
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: Aktivator MO mixed with alcohol and lutrol (1:1)

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Wistar II
Sex:
male/female

Administration / exposure

Route of administration:
other: two tests with aerosols/spray mist
Type of inhalation exposure:
whole body
Vehicle:
other: alcohol and lutrol (1:1)
Remark on MMAD/GSD:
MMAD was not determined
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:test 1: Dynamic spray inhalation equipment (NIESSEN et al., 1963), test 2: static spray inhalation chamber
- Exposure chamber volume: unknown for test 1 (dynamic spray inhalation); 2 m³ test 2 (static spray inhalation)

TEST ATMOSPHERE
- Samples taken from breathing zone: collection of samples for calculation of average concentration in air, but location of sample collection was not reported

VEHICLE
- Composition of vehicle (if applicable): alcohol and lutrol
- Concentration of test material in vehicle (if applicable): unknown
Analytical verification of test atmosphere concentrations:
not specified
Remarks:
Report stated analytical concentration values but neither sample collection method, location and time point of sample collection nor type of analytical verification was reported
Duration of exposure:
4 h
Concentrations:
Test 1 (dynamic spray inhalation, males/females): theoretical concentrations: males: 0.25, 1, 2.5 mg/L (single exposure) and 0.5 and 2.5mg/L (repeated exposure; 5 x), females: 2.5 mg /L; measured concentrations: 0.064, 0.141, 0.296, 0.662, 0.9 mg/L (males), 0,82 mg/L (females)
Test 2 (static spray inhalation, males): theoretical concentration: 1 mg/L, measured concentration: 0.344 mg/L
No. of animals per sex per dose:
Test 1: 20 males per dose for 0.25, 5 x 0.5, 1, 2.5, 5 x 2.5 mg/L; 20 females per dose 2.5 mg/L
Test 2: 10 male rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LC0
Effect level:
2.5 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Result from Test 1
Key result
Sex:
female
Dose descriptor:
LC0
Effect level:
2.5 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Result from Test 1
Key result
Sex:
male
Dose descriptor:
LC0
Effect level:
2.5 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
20 h
Remarks on result:
other: Result from Test 1 repeated 4h exposure (5x)
Key result
Sex:
male
Dose descriptor:
LC0
Effect level:
0.662 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Result from Test 1
Key result
Sex:
female
Dose descriptor:
LC0
Effect level:
0.82 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Result from Test 1
Key result
Sex:
male
Dose descriptor:
LC0
Effect level:
0.9 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
20 h
Remarks on result:
other: Result from Test 1; repeated 4h exposure (5 x)
Mortality:
Test 1: none
Test 2: none
Clinical signs:
other: Test 1: clinical signs were observed in all animals only at the highest nominal dose of 2.5 mg/L. Test 2: none

Any other information on results incl. tables

Test 1 (Dynamic spray inhalation)
Species Concentration in air (mg Aktivator MO/L) Exposure duration per day Exposure days Toxicological findings in 14 days
theoret. measured
rat (male) 0.25 0.064 4 1 0/0/20
1.00 0.296 4 1 0/0/20
2.50 0.662 4 1 0/20/20
rat (female) 2.50 0.820 4 1 0/20/20
mice (male) 1.00 0.325 4 1 0/20/20
2.50 0.724 4 1 1/20/20
rat (male) 0.50 0.141 4 5 0/0/20
2.50 0.900 4 5 0/20/20
*/*/* deaths/clinical signs/total number of animals
Test 2
no detailed results, species used in this Test: 1 rabbit, 5 guinea pigs, 10 male rats, 20 male mice No clinical signs or irritation detected for several species

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
For acute toxicity by inhalation only a LC0 was determined. The LC0 for inhalation of the test material in male rats was 2.5 mg/L nominal for both sexes or 0.662 mg/L analytical and in female rats 0.82 mg/L analytical.

Other results are also available for mice, rabbits and guinea pigs from Test 2 (see any other information on results).
Executive summary:

In an acute inhalation toxicity, male and female Wistar II rats were exposed by inhalation route to the test substance in alcohol and lutrol (1:1) in 2 different tests for 4 hours to the whole body at nominal concentrations of 0.25 – 2.5 mg/L. Animals then were observed for 14 days. Due to lack of mortality the LC50 could not be determined.

LC0Males = 2.5 mg/L (0.662 mg/L)

      Females = 2.5 mg/L (0.820 mg/L)

Other results are also available for mice, rabbits and guinea pigs from Test 2 (see any other information on results).

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