Dimethoxydiphenylsilane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-01-23 - 1980-02-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study was well documented and meets generelly accepted scientific principles, but was not conducted in compliance with GLP. The study was carried out prior to the publication of the OECD test guidelines, but the experimental design is equivalent or similar to that described in the OECD TG 403.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

(no details on test material purity given)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethoxydiphenylsilane

EC Number:

229-929-1

EC Name:

Dimethoxydiphenylsilane

Cas Number:

6843-66-9

Molecular formula:

C14H16O2Si

IUPAC Name:

dimethoxydiphenylsilane

Details on test material:

- Name of test material (as cited in study report): Diphenyldimethoxy Silane, DPDMS
- Physical state: clear liquid of medium viscosity
- Storage condition of test material: room temperature
- Date of delivery: 1980-01-17

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
- Weight at study initiation: 249-349 g
- Housing: individually in suspended wire-mesh cages
- Diet: Purina Lab-Blox 5001 Laboratory Animal Diet, ad libitum
- Water, ad libitum
- Acclimation period: 7 days of quarantine

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass and stainless steel inhalation chamber
- Exposure chamber volume: 38 l
- Method of holding animals in test chamber: individually caged in stainles steel wire-mesh cages
- Source and rate of air: 10 l air/min
- System of generating vapour: The vapour was generated by tubbling 10 l air/min through a 500-ml glass, 2-necked flask containing a measured amount of liquid test material. The flask was placed in a water bath maintained at 22 °C. The vapour was excited from the top of the flask and was carried into the inhalation chamber via tubing inserted into the front of the chamber.

TEST ATMOSPHERE
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

>= 4 h

Concentrations:

0.42 mg/l nominal concentration (calculated by dividing the weight of compound generated from the flask by the total airflow passed through the exposure chamber during the generation period)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: on days 0, 7, and 14
- Necropsy of survivors performed: yes

Statistics:

Analysis of covariance was used for body weights.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.42 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: No mortality occurred. No test material related effects on clinical signs, behaviour, and body weights were observed. Gross pathology revealed increased frequency of enlarged deep cervical and mandibular lymph nodes in treated rats relative to controls.

Mortality:

No mortality occurred.

Clinical signs:

other: Group 1 (conrol group): Throughout the exposure and the 14-day holding period, the control animals exhibited normal appearance and behaviour. Group 2 (treatment group): After 2 min of exposure, all animals were sniffing the air. No further changes were o

Body weight:

Analysis of covariance indicated that there were no significant differences between groups at either interval indicative of a compound-related effect.

Gross pathology:

The test material exposed rats exhibited an increased frequency of enlarged deep cervical lymph nodes and mandibular lymph nodes relative to the control group rats.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

The test item was tested for acute inhalation toxicity equivalent or similar to the OECD TG 403 but not in compliance with GLP. The LD 50 was found to be > 0.42 mg/l air for both males and femals. No mortality occured and no adverse effects were observed. Hence, classification for acute inhalation toxicity according to 67/584/EEC and EC/1272/2008 is not warranted.