Bis(trimethoxysilylpropyl)amine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only a summary report was available for review.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats were exposed to substantially saturated vapour for 6 h. The vapour was produced by enclosing the test material in a sealed 120 l animal chamber for approximately 18 h (static concentration). Oxygen was added, as needed, to maintain a chamber oxygen content of approximately 20%.

GLP compliance:

no

Test type:

other: inhalation risk test

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(trimethoxysilylpropyl)amine

EC Number:

280-084-5

EC Name:

Bis(trimethoxysilylpropyl)amine

Cas Number:

82985-35-1

Molecular formula:

C12H31NO6Si2

IUPAC Name:

3,3,11,11-tetramethoxy-2,12-dioxa-7-aza-3,11-disilatridecane

Details on test material:

- Name of test material (as cited in study report): Organofunctional Silane Y-9492
- Physical state: clear, non-viscous liquid
- Lot/batch No.: 09989
- Identification: NB 2225-99
- BRRC Sample No.: 44-365
- Date of Receipt: 15 December 1981

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Hilltop-Wistar albino rats
- Weight at study initiation: 200-300 g
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: air/oxygen mixture

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: sealed animal chamber
- Exposure chamber volume: 120 l
- Method of conditioning air: test material was enclosed in a sealed 120 l animal chamber for 18 h
- Temperature: 23°C

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

6 h

Concentrations:

substantially saturated vapour
(i.e. approximately 1.8 mg/m³, calculated based on a vapour pressure of 0.013 Pa, see corresponding IUCLID Section 4.6)

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: Animal weights were recorded at day 0 (prior to dosing), and at days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

LD50 was calculated by the moving average method and is based on a 14 days observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

other: Substantially saturated vapour

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: (i.e. approximately 1.8 mg/m³, calculated based on a vapour pressure of 0.013 Pa, see corresponding IUCLID Section 4.6)

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

other: Ataxia and slow righting reflex was observed on removal.

Body weight:

Males: weight change of 45-50 g (7 days) and 65-85 g (14 days)
Females: weight change of 4-10 g (7 days) and 5-26 g (14 days)

Gross pathology:

Gross pathology revealed no abnormal findings.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In a non-guideline study, which was not compliant to GLP, the test item was tested for acute inhalation toxicity. Substantially saturated vapour did not cause any deaths in any of the male and female rats after 6 h of exposure. Ataxia and slow righting reflex was observed on removal. Gross pathology revealed no remarkable findings. The LC50 was found to be > vapour saturation at 23°C.