3-chloropropyltrimethoxysilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-05-17 - 1993-06-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: BOR:WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Harlan Winkelmann GmbH, 33176 Borchen, Gartenstr. 27

- Age at study initiation: 6 - 8 weeks

- Weight at study initiation: 131-180 g

- Fasting period before study: 16 hours before commencement of study.

-Housing: Conventional, maximum of 5 animals/cage

- Diet: Ssniff R 10 Comprehensive diet for rats (ad libitum)

- Water: ad libitum

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20°C ± 3°C

- Humidity (%): 30-70%

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: Not stated

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.85 cm3/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/group (2 of each sex in preliminary study and 3 of each sex in actual study. The final results include all animals.)

Control animals:

not specified

Details on study design:

A group of ten (5 male and 5 female) rats was given a single oral dose of undiluted test substance at a dose level of 2000 mg/kg bw. Animals were observed 1 and 4 hours after dosing and then once a day for 14 days. Bodyweights were recorded on the day of treatment and on days 7 and 14. All animals were subject to gross necropsy examination for any macroscopic abnormalities.

Statistics:

Not applicable.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities in response to the exposure.

Clinical signs:

other: Up to six hours after administration clinical signs of toxicity were noted including abnormal gait, squatting, staggering, salivation and lacrimation, hypothermia, and uncontrolled movements. All animals appeared normal by the 24 hour observation point.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral LD50 (rat) >2000 mg/kg was determined in a reliable study conducted in accordance with the now deleted OECD 401 test guideline and in compliance with GLP.