Trimethoxy(2-methylpropyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09.03.1993 to 26.03.1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxy(2-methylpropyl)silane

EC Number:

242-272-5

EC Name:

Trimethoxy(2-methylpropyl)silane

Cas Number:

18395-30-7

Molecular formula:

C7H18O3Si

IUPAC Name:

trimethoxy(2-methylpropyl)silane

Details on test material:

- Name of test material (as cited in study report): Dynasylan IBTMO
- Substance type: Organosilane
- Physical state: Liquid
- Stability under test conditions: Stable for <1 year
- Storage condition of test material: Closed container away from humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Winkelmann, 4799 Borchen
- Age at study initiation: no data
- Weight at study initiation: All within 20% of mean
- Fasting period before study: 16 hours before administration
- Housing: Maximum of five per Makrolon type III cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.03.1993 to 26.03.1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.15 cm3/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: 30 minutes, then 1, 2, 3, 4, 5, and 6 hours, and then daily after administration. Body weights: before treatment, and then weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology and histopathology where gross effects found

Statistics:

none

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

Clinical signs:

other: Within the first three hours after administration in males and the first six hours in females, there were signs of toxicity. Within three hours the signs were ruffled fur, crouching posture, mild sedation, ataxia, and swaying motion. By five to six hours

Gross pathology:

There were no macroscopic treatment-related findings in animals that survived to the end of the observation period. There were findings suggestive of irritation of the intestinal mucosa in females. One male had a distinct right kidney renal pelvic enlargement, which was not thought to be treatment-related.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study conducted to OECD test guideline (now deleted 401; reliability score 1) and GLP, the oral LD50 was greater than 2000 mg/kg bw in male and female rats. Within the first three hours after administration in males and the first six hours in females, there were signs of toxicity. Within three hours the signs were ruffled fur, crouching posture, mild sedation, ataxia, and swaying motion. By five to six hours there were no signs in 8/10 animals. Six hours after administration, one female had signs of severe toxicity (ruffled fur, medium to heavy sedation, ataxia, prone position, hypothermia, laboured breathing, closed eyes and chromodacryorrhea). While all other animals ate their food, after three hours this animal still refused to eat. After 24 hours there were no signs of toxicity in any of the animals.