Trichloro(methyl)silane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP and an occlusive dressing was used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: DOT Corrosivity test

GLP compliance:

not specified

Remarks:

Although a GLP statement was not included with the report, it is known that Bushy Run Research Center (BRRC) operated as a GLP-facility at the time the testing was conducted.

Test material

Test material information

Constituent 1

Reference substance name:

Trichloro(methyl)silane

EC Number:

200-902-6

EC Name:

Trichloro(methyl)silane

Cas Number:

75-79-6

Molecular formula:

CH3Cl3Si

IUPAC Name:

trichloro(methyl)silane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

One male and one female were used.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

undiluted; 0.5 mL

Duration of treatment / exposure:

3 minute(s)

Observation period:

2 days

Number of animals:

2

Details on study design:

0.5 mL (undiluted) was applied to the clipped, intact skin under a gauze patch and was loosely covered with impervious sheeting. The animals were restrained for the 3-min contact period. Excess sample was removed after contact. Skin reaction was scored by the method of Draize at one hour and at 1 and 2 days after dosing.

Results and discussion

In vivo

Results

Irritation parameter:

other: overall result

Basis:

mean

Time point:

other: 1 hour

Reversibility:

not reversible

Remarks on result:

other: Full thickness necrosis in both test animals

Irritant / corrosive response data:

A 3-minute application of 0.5 ml of the test material undiluted to occluded rabbit skin resulted in moderate edema and full thickness necrosis on 2 of 2 rabbits within one hour after contact.  Erythema was not visible around the necrosed site.  Ulceration was observed on both animals at 24 hours with the tissue of the dose site of one animal apparently completely destroyed.  This animal was euthanized for humane  reasons.  The remaining animal had severe ulceration (tissue destruction) at 48 hours and was euthanized after examination.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 2
60 min	0/0	2/2
24 h	U/0	U/2
48 h	-/0	-/3

 *) Reversibility: c. = completely reversible;n.c. = not completely reversible; n. = not reversible. U= Scoring impossible because of severe ulceration.

Chemical fuming upon contact; moderate edema, full thickness necrosis, severe ulceration (tissue destruction) on 2 of 2 rabbits. The application of test material to rabbit skin resulted in severe irritation, including full thickness necrosis and complete ulceration. Erythema was not visible around the necrosed site. Ulceration was observed on both animals at 24 hours with the tissue of the dose site of one animal apparently completely destroyed. This animal was sacrificed for humane reasons at this time. The remianing animal had sevsere ulceration (tissue destruction) at 48 hours and was sacrificed after examination.

 

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was determined to be corrosive in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP. On the basis of the severe effects observed, a proposal for classification as (Corrosive; Skin Corr 1A) is made, which is more stringent than the existing official EU classification.