Trimethoxy(2,4,4-trimethylpentyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 April - 21 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

FEDERAL DEPARTMENT OF THE INTERIOR, Bern (Switzerland)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxy(2,4,4-trimethylpentyl)silane

EC Number:

251-995-5

EC Name:

Trimethoxy(2,4,4-trimethylpentyl)silane

Cas Number:

34396-03-7

Molecular formula:

C11H26O3Si

IUPAC Name:

trimethoxy(2,4,4-trimethylpentyl)silane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: HanIbm: WIST (SPF)
- Source: BRL, Biological Research Laboratories Ltd., Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (males) and 10 weeks (females)
- Weight at study initiation: 206-216 g (males), 171-190 g (females)
- Fasting period before study: 17.5-19.5 hours prior to treatment, and 3.5 hours after treatment
- Housing: Groups of 3 in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, Switzerland)
- Diet: Pelleted standard Kliba 3433, batch nos 94/97 and 20/98 rat maintanance diet (Kliba Mühlen AG, Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC.
- Water: Community tap water ad libitum. Results of bacteriological, chemical, and contaminant analyses are archived at RCC.
- Acclimation period: one week under laboratory conditions, after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 40-66
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (Music was played during the light period.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The test article was readily soluble in corn oil.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The preperation was made shortly before dosage as a weight by volume preparation. Homogeneity of the test article in the vehicle was maintained during treatment.

Doses:

2000 mg/kg bw (step 1 and 2)

No. of animals per sex per dose:

step 1: 3 males
step 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Four times during test day 1 and once daily during days 2-15
- Frequency of weighing: On test day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No statistical analysis was used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the study period.

Body weight:

other body weight observations

Remarks:

The body weight was within the range commonly recorded for animals of this strain and age.

Gross pathology:

No macroscopic findings were observed at necropsy.

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 oral toxicity according to the OECD TG 423 and in complinance with GLP. No deaths occurred and no signs of toxicity were observed. The LD50 for both males and females was found to be > 2000 mg/kg bw. Hence, classification according to Regulation (EC) No. 1272/2008 is not warranted.