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Toxicological information

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:
01.12.1981 to 17.12.1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, New York.
- Age at study initiation: 9-11 weeks
- Weight at study initiation: Not defined
- Fasting period before study: No data
- Housing: Individually in suspended wire mesh-bottom exposure cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Four weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71-73 (22-23 °C) 
- Humidity (%): 69-78
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 01.12.1981 To: 17.12.1981

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass exposure chamber.
- Exposure chamber volume: 225 litre.
- Method of holding animals in test chamber: none
- Source and rate of air: Room air. Flow rate of 50 l/minute.
- Method of conditioning air: No data.
- System of generating particulates/aerosols: Spraying Systems 1/4 (?) J Nebulizer.
- Method of particle size determination: cascade impaction.
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: Temperature (°F): 71-73 (22-23 °C); Humidity (%): 69-78.


TEST ATMOSPHERE
Mass median aerodynamic diameter was determined hourly by cascade impaction for each exposure level and ranged from 1.4 to 2.0 microns.  
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric methods and gas chromatography (considered secondary due to recovery inefficiencies, however, gas chromatographic values averaged 85% of the gravimetrically determined concentrations).
Duration of exposure:
4 h
Concentrations:
0.8, 1.9, and 5.3 mg/L
No. of animals per sex per dose:
30
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations. Weighing on 1, 2, 4 or 5, 7 and 14 days after exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: gross necropsy.

Statistics:
No details.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.3 mg/L air
Exp. duration:
4 h
Mortality:
No deaths occurred at the two lower concentrations (1.9 and 0.8 mg/L).  At the highest concentration (5.3 mg/L), three rats died, one male on day 1, one female on day 1 and one female on day 2. 
Clinical signs:
other: Following exposures, all rats exhibited varying amounts of test substance contamination on the fur.  Clinical signs included excessive lacrimation, dry and moist rales, nasal discharge, and yellow staining in the anal-genital area.  These signs were consi
Body weight:
There was also a transient dose-related body weight depression seen in all groups (including the control) during the first week, however, mean body weights exceeded pre-exposure values by day 14 in all groups.
Gross pathology:
Discolored lungs and autolytic changes were seen in the three rats that died.  There were no gross abnormalities noted at the necropsy of survivors.

Any other information on results incl. tables

Table of concentrations and particle sizing data of Prylog (mg/l and µm)

 Group  Method  Mean conc./mean MMD   Hourly air samples mg/l/MMD            Nominal conc.
       1  2  3  4  
 1  Analytical  4.8  4.0  4.9  5.2 4.9   25.3
   Gravimetric  5.3/1.9  5.7/2.0  5.4/1.8  5.4/1.8  4.7/1.8  
 2  Analytical  1.7  1.7  1.8  1.8  1.4  7.1
   Gravimetric  1.9/1.7  0.9/1.7  2.5/1.6  2.1/1.6  2.0/1.7  
 3  Analytical  0.6  0.7  0.6  0.6  0.6 2.3 
   Gravimetric  0.8/2.0  1.1/1.6  0.7/1.5  0.7/1.4  0.6/1.5   
               

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a good quality acute inhalation study (reliability score 1) conducted to OECD 403, and GLP, an aerosol of unchanged Prylog (Silane, trimethoxy 3-(oxiranylmethoxy)propyl) gave an LC50 greater than 5.3 mg/l in rats.
Executive summary:

In a good quality acute inhalation study (reliability score 1) conducted to OECD 403, and GLP, an aerosol of unchanged Prylog (Silane, trimethoxy 3-(oxiranylmethoxy)propyl) gave an LC50 greater than 5.3 mg/l in rats.