Hydroxytrimethylsilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Remarks:

Therefore assumed not to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxytrimethylsilane

EC Number:

213-914-1

EC Name:

Hydroxytrimethylsilane

Cas Number:

1066-40-6

Molecular formula:

C3H10OSi

IUPAC Name:

hydroxytrimethylsilane

Details on test material:

- Name of test material (as cited in study report): Trimethylsilanol
- Substance type: Alkylsilane
- Physical state: Liquid
- Analytical purity: Not stated

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Ltd., Huntingdon, UK.
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

Four hours

Observation period:

72 hours

Number of animals:

Three female

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Not stated


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: Four hours.


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal: All

Time point:

other: All

Score:

0

Max. score:

4

Remarks on result:

other: No reaction in any animal

Irritant / corrosive response data:

There was no erythema, or oedema in any of the animals.

Other effects:

No other effects reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a skin irritation study conducted to OECD 404, but not to GLP (reliability score 2), New Zealand white female rabbits did not show any signs of skin irritation following a four hour dermal exposure to 0.5 ml undiluted trimethylsilanol. There were no signs of systemic toxicity.

Executive summary:

Three female New Zealand white rabbits were dermally exposed to 0.5 ml of undiluted trimethylsilanol applied to shaved, intact skin for four hours. After four hours the test substance was washed off the skin with water, and skin reactions were recorded for up to 72 hours. None of the animals had any erythema or oedema at any time point, and therefore the test substance was concluded not to be a skin irritant.