Chlorotrimethylsilane

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:

other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Chlorotrimethylsilane

EC Number:

200-900-5

EC Name:

Chlorotrimethylsilane

Cas Number:

75-77-4

Molecular formula:

C3H9ClSi

IUPAC Name:

chloro(trimethyl)silane

Details on test material:

No data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Ltd.
- Age at study initiation: No data
- Weight at study initiation: 3.4-3.8 kg
- 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): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES:No data

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

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:

Up to 14 days where necessary.

Number of animals:

Three males

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: NEEDS PROPER TRANSLATION


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: four hours


SCORING SYSTEM: Draize and OECD test guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: up to 14 days

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Not assessable due to necrosis.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: up to 7 days

Reversibility:

not reversible

Remarks on result:

other: Not assessable due to necrosis. Animal died on Day 10.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: up to day 7

Max. score:

0

Remarks on result:

other: No reaction observed

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: up to Day 14

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Not assessable on Day 14 due to necrosis

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: up to Day 7

Score:

ca. 2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: Animal died on Day 10

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: up to Day 7

Max. score:

0

Remarks on result:

other: No reaction observed

Irritant / corrosive response data:

One of the animals did not have any skin reactions. Volatilisation or hydrolysis of product must be considered. A PROPER TRANSLATION IS REQUIRED.

Other effects:

One animal died after 10 days.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a well conducted skin irritation study (reliability score 2) conducted according to OECD test guideline 404 (GLP status not known) trimethylchlorosilane was corrosive to the skin of rabbits.

Executive summary:

In a well conducted OECD 404 study, New Zealand white rabbits were exposed to 0.5 ml trimethylchlorosilane for four hours At the end of the exposure period excess test substance was washed off the skin with water. Skin reaction were then observed for up to 14 days. One animal died on Day 10, but had severe skin reactions, including corrosion, up to this point. One of the remaining animals had oedema, erythema and necrosis up to Day 14, although the reaction was often difficult to score due to the severity of the necrosis. The third animal did not have any reaction to the test substance, but this was considered to be an artefact, possibly due to evaporation of the test substance. Therefore trimethylsilane was considered to be corrosive to the skin of rabbits in this study.