Cyclohexyldimethoxymethylsilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12.07.1995 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:

other: 92/69/EEC, Method B3

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

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: 10-14 weeks
- Weight at study initiation: Males: 210-238 g; Females: 201-234 g
- Fasting period before study: No
- Housing: Individual during exposure period, and groups of 5/6 at other times, in suspended polypropylene cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 49-60
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12.07.1995 To: 26.07.1995

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: Approximately 10%
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with moist cotton wool
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.14 ml/kg

Duration of exposure:

24 h

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: Animals were checked for mortality and signs of toxicity at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily thereafter. Individual bodyweights were recorded prior to application of the test substance on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: dermal for signs of irritation, macroscopic examination

Statistics:

Mortality data were used to calculate the acute dermal median lethal dose.

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.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were observed.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No signs of irritation were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study conducted to OECD Test Guideline 402 and in compliacne with GLP (reliability score 1), the LD50 for cyclohexyldimethoxymethylsilane was at least 2000 mg/kg bw in rats. There were no signs of systemic toxicity or dermal irritation.