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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
[as stated in SIAR, 2003, not evident from the study report seen by this reviewer
GLP compliance:
not specified
Remarks:
SIAR (2003) notes that this laboratory was GLP certified at the date of this study
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropyltriethoxysilane
EC Number:
213-048-4
EC Name:
3-aminopropyltriethoxysilane
Cas Number:
919-30-2
Molecular formula:
C9H23NO3Si
IUPAC Name:
3-aminopropyltriethoxysilane

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: "Hilltop Wistar" - no further details given
- Age at study initiation: not stated
- Weight at study initiation: 200-300 g
- Fasting period before study: no details
- Housing: no details
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): mean chamber concentration 25
- Humidity (%): no details
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): no details

IN-LIFE DATES: no details

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: dynamic
- Exposure chamber volume: 9 l
- Method of holding animals in test chamber: not stated
- Source and rate of air: 2.5 l air/min passed through neat sample at 19 deg C then through test chamber
- Method of conditioning air: air passed through neat sample of test material at 19 deg C
- Temperature, humidity, pressure in air chamber: test chamber 25 deg C, no further details

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography
- Samples taken from breathing zone: yes, taken from exposure chambers

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: -
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): -

Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
6 h
Remarks on duration:
OECD 403 recommends exposure for 4 h
Concentrations:
"Substantially saturated vapour", measured concentration 5 (+/-2) ppm (males) and 16 (+/-5.8) ppm (females) test material in the test chambers.
The test material concentration in vapour passing to the female test chamber was 90 ppm. Reaction with moisture in the test chambers (from exhaled air and urine) resulted in extensive hydrolysis to ethanol and unspecified other products. Ethanol concentrations of 380 and 490 ppm were reported for test chambers containing the males and females, respectively. [16 ppm would be equivalent to around 145 mg/m3.]
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: daily observations, body weights on days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
None

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 5 ppm
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Equivalent to 45.2 mg/m3 or 0.0452 mg/L
Key result
Sex:
female
Dose descriptor:
LC50
Effect level:
> 16 ppm
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Equivalent to 145 mg/m3 or 0.145 mg/L
Mortality:
None (see table 1).
Clinical signs:
other: None (see table 1). Full data are not presented.
Body weight:
See table 1
Gross pathology:
None (see table 1). Full data are not presented.
Other findings:
None

Any other information on results incl. tables

Table 1: Concentrations, mortality or evident toxicity

Sex

Analytical Conc. (ppm)

Mortality (No./total)

Mean body weight change (g)

0-7 days

Mean body weight change (g)

0-14 days

Number with overt toxicity

Number with remarkable gross pathology

males

5 (+/- 2)

0/5

51 (36-61)

71 (62-79)

0/5

0/5

females

16 (+/- 5.8)

0/5

10 (5-14)

18 (9-27)

0/5

0/5

LT50 (median lethal time)
Males: > 6.0 h
Females: > 6.0 h

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A well reported study, conducted according to generally accepted scientific standards and probably in accordance with GLP, found no toxicity when male and female rats were exposed for 6 h to an atmosphere 'substantially saturated' with the test material. The mean measured concentrations of the test material (after hydrolysis) were 5 and 16 ppm, for male and female rats, respectively.

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