(3-chloropropyl)dimethoxymethylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.03.2002 to 13.08.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloropropyl)dimethoxymethylsilane

EC Number:

242-056-0

EC Name:

(3-chloropropyl)dimethoxymethylsilane

Cas Number:

18171-19-2

Molecular formula:

C6H15ClO2Si

IUPAC Name:

(3-chloropropyl)dimethoxymethylsilane

Test animals

Species:

rat

Strain:

other: CD/Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: Males: 41 days; Females: 48 days
- Weight at study initiation: Males: 206-224 g; Females: 172-197 g
- Fasting period before study: 16 hours before treatment
- Housing: Type III Makrolon cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.04.2002 To: 02.05.2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle: No data
- Justification for choice of vehicle: Not stated, but assumed to be low toxicity
- Lot/batch no.: No data
- Purity: No data


MAXIMUM DOSE VOLUME APPLIED: 1.96 ml/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit dose

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

Three

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: before and immediately at 5, 15, 30 and 60 minutes, as well as at 3, 6 and 24 hours after administration. Weight: before and then weekly after administration
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 200 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg bw resulted in one male and two female deaths. No deaths at 200 mg/kg bw

Clinical signs:

other: All animals of both sexes showed slight to moderately reduced motility, slight to moderate ataxia, slight to moderately reduced muscle tone and slight to moderate dyspnoea from 15 minutes up to 24 hours after administration at 2000 mg/kg bw. There were no

Gross pathology:

No abnormalities were found.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In an acute toxic class study, conducted to OECD Test Guideline 423 and to GLP (reliability score 1), the acute oral LD50 for 3-chloropropyl(dimethoxy)methylsilane was in the range 200-2000 mg/kg bw in rats. All animals of both sexes showed slight to moderately reduced motility, slight to moderate ataxia, slight to moderately reduced muscle tone and slight to moderate dyspnoea from 15 minutes up to 24 hours after administration at 2000 mg/kg bw.