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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Detail missing on animals and environmental conditions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-trimethoxysilylpropyl methacrylate
EC Number:
219-785-8
EC Name:
3-trimethoxysilylpropyl methacrylate
Cas Number:
2530-85-0
Molecular formula:
C10H20O5Si
IUPAC Name:
3-trimethoxysilylpropyl methacrylate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Source: Charles River Breeding Laboratories (Kingston, NY)

- Age at study initiation: ca. 6 weeks

- Housing: Stainless steel cages, with wire floors

- Diet: Agway certified rodent chow

- Water: provided by an automatic water system

- Acclimation period: 2 weeks

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: distilled water adjusted to pH4 with acetic acid
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure chamber volume: 120 liters

- System of generating particulates/aerosols: Four solo-sphere nebulizers containing a 15% (w/w) solution of 3-(trimethoxysilyl)propyl methacrylate (in distilled water, adjusted to pH 4 with acetic acid) were connected to 2 large triple-necked flasks (to trap large liquid droplets) which were, in turn, connected to the exposure chamber. Dried air was passed into each nebulizer, operating at a pressure of 20 p.s.i, and the resulting aerosol conducted into the animal chamber.

- Method of particle size determination: One sample of chamber atmosphere was analysed for particle size. A 3 minute flow of air at 10 l/min was conducted through a Sierra Cascade Inspector. Particles were collected on 3 stages of glass fibre filters. Several chamber air samples were subjected to gas chromatographic analysis to determine methanol concentration.

TEST ATMOSPHERE

- Brief description of analytical method used: Every 30 minutes during exposure, a sample of chamber atmosphere was drawn through a tared fiberglass filter at the rate of 2.2 l/min. After 2 min the filter was removed, dried in a drying overn to a constant weight and the final weight recorded. The change in weight represented the amount of hydrolysed silane collected. According to the sponsor, this represents ca. 72.17% of the test substance. This factor, along with the volume of air sampled, was used to calculate the concentration of test substance in the chamber air.

- Samples taken from breathing zone: yes

VEHICLE

- Composition of vehicle (if applicable): distilled water

- Concentration of test material in vehicle (if applicable): Distilled water was adjusted to pH 4 with acetic acid and used to make a 15% solution of test substance.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
GC
Duration of exposure:
4 h
Concentrations:
2.28 mg/L
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were weighed just before exposure and at 7 and 14 days after exposure. All rats were observed frequently on the day of the test and daily during the subsequent observation period.

- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was included in the report.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.28 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
There were no deaths.
Clinical signs:
other:
Body weight:
All animals gained weight.
Gross pathology:
No remarkable gross pathologic findings were seen.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute inhalation toxicity study, conducted in a similar manner to OECD 403 but pre-GLP, an LC50 value of >2.28 mg/l (aerosol exposure) was determined.