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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:
7 Feb 1990 to 21 Feb 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Deviations unlikely significantly to affect the outcome of the study: excursions from recommended relative humidity and temperature; limited reporting of clinical observations.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar derived Crl:WI(WU)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, GERMANY
- Age at study initiation: 7 weeks
- Weight at study initiation: mean - 218 g (males), 166 g (females)
- Fasting period before study: none stated
- Housing: (after exposure) 5 males or 5 females per suspended stainless steel cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): during exposure: mean 22.6; after exposure: 22 +/-3 (excursion 18.5 for 1 h)
- Humidity (%): during exposure: mean 79 +/-15 (excursion >70% for 2 h); after exposure: 30-70 (excursions 29, 74, 95 for 1 h on each occasion)
- Air changes (per hr): during exposure: 38; after exposure: 10
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1990-02-07 To: 1990-02-21

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: horizontal glass chamber; animals separated by perforated stainless steel plates
- Exposure chamber volume: 16 L (total volume)
- Method of holding animals in test chamber: see above
- Source and rate of air: 0.6 m³/h; flow velocity 34 m/h; ventilation frequency 38/h
- System of generating particulates/aerosols: heated air bubbled through heated test material at 35° C, passed through heated Pall filter (30° C) to remove aerosol as far as possible
- Method of particle size determination: to determine aerosol content: 11-stage cascade impactor
- Treatment of exhaust air: no details
- Temperature, humidity, pressure in air chamber: (mean of hourly measurements) 22.6° C; 79 +/-15%; pressure unstated

TEST ATMOSPHERE
- Brief description of analytical method used: hourly GC analysis
- Samples taken from breathing zone: yes

TEST ATMOSPHERE: 22.2+/-6.9 g/m³ (4 measurements); nominal 59.8 g/m³; particle size tabulated (about 1% of the total test atmosphere consisted of aerosol.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Single exposure concentration:
22.2 +/-6.9 g/m³ (measured)
59.8 g/m³ (nominal)
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: observations daily; body weights prior to exposure and on observation days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
None relating to LC50.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 22 200 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
One of each sex died during exposure. One male died on observation day 4.
Clinical signs:
other: Shortly after exposure, restlessness and irregular breathing was observed followed by narcosis and deep and irregular breathing. Wet noses and dirty fur were common observations on the first day of the observation period, but there were no abnormalities t
Body weight:
Body weights were reduced in two females on days 14, or 7 and 14.
Gross pathology:
The lungs of the three animal that died during treatment or observation were discoloured red, spotted or swollen. No abnormalities were found in the remaining animals autopsied on day 14.
Other findings:
None reported.

Any other information on results incl. tables

Table 1: Concentrations, exposure conditions and mortality per animals treated

Nominal

Conc. (g/m3)

Analytical Conc. (g/m³ ± SD )

Mortality (dead/total)

Males

Females

Combined

59.8

22.2 +/- 6.9

2/5

1/5

3/10

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute inhalation study according to OECD 403 and in accordance with GLP (reliability score 1) the LD50 for trimethoxy(propyl)silane was in excess of 22200 mg/m³ in the rat.