Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals 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:
5M, 5F
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: During exposure, a dense fog was present in the animal chamber, preventing observation of the test rats. After exposure, slow righting reflex and laboured breathing were apparent. At one day, the animals were fully recovered.
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:
The acute inhalation LC50 value of >2.28 mg/l (aerosol exposure) was determined in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.