Cyclohexyldimethoxymethylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.07.1995 to 26.07.1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 92/69/EEC

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexyldimethoxymethylsilane

EC Number:

402-140-1

EC Name:

Cyclohexyldimethoxymethylsilane

Cas Number:

17865-32-6

Molecular formula:

C9H20O2Si

IUPAC Name:

cyclohexyldimethoxymethylsilane

Test material form:

liquid

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 (UK) Ltd
- Age at study initiation: 5-8 weeks
- Weight at study initiation: Males: 155-187 g; Females: 126-146 g
- Fasting period before study: yes
- Housing: Groups of five in polypropylene cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 47-66
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 06.07.1995 To: 26.07.1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.14 ml/kg

Doses:

2000 mg/kg bw/day

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: Animals were observed for deaths or overt signs of toxicity half, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test substance was made.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths occurred.

Mortality:

There were no deaths.

Clinical signs:

other: Common signs of systemic toxicity were hunched posture, lethargy, ataxia and reduced breathing rate with additional signs of laboured breathing, loss of righting reflex and ptosis. One male was comatose four hours after dosing. Animals returned to normal

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

- Organ weights: Not measured
- Histopathology: Not conducted
- Potential target organs: None identified

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study conducted according to the now deleted OECD Test Guideline 401 and in compliance with GLP (reliability score 1), the LD50 for cyclohexyldimethoxymethylsilane was greater than 2000 mg/kg bw in rats. Common signs of systemic toxicity were hunched posture, lethargy, ataxia and reduced breathing rate with additional signs of laboured breathing, loss of righting reflex and ptosis. One male was comatose four hours after dosing. Animals returned to normal within one day of dosing. There were no other adverse findings.