Chloromethyltrimethylsilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Chloromethyltrimethylsilane

EC Number:

219-058-5

EC Name:

Chloromethyltrimethylsilane

Cas Number:

2344-80-1

Molecular formula:

C4H11ClSi

IUPAC Name:

(chloromethyl)trimethylsilane

Constituent 2

Reference substance name:

Silane,(chloromethyl)trimethyl-

IUPAC Name:

Silane,(chloromethyl)trimethyl-

Test material form:

other: colourless liquid

Details on test material:

Purity 99.8%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

New Zealand White Rabbits Hsdlf:NZW.
Source: Harlan Winkelmann GmbH, D-33178 Borchen
3 female animals were used.
The animals were derived from a controlled full barrier maintained breeding
system (SPF).
Semi-barrier in an air conditioned room
Temperature: 18 ±3 QC
ReI. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to ssniff K-H, 4 mm V2333-000 complete diet for rabbits maintenance,
rich in crude fibre, totally pathogene free (TPF)
Free access to tap water (drinking water, municipal residue control,
microbiol. controlled periodically)
Certificates of food, water and bedding are filed at BSL Bioservice
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Adequate acclimatization period
Approximately 24 hours before the test, fur was removed. from the dorsal
area of the trunk by clipping.
The test item was applied as a single dose to a small area (approx. 6 cm2
) of
skin on one side of the dorsal area and covered with a gauze patch, which
was held in place with non-irritating tape. The untreated other side served as
control. The test item was applied to a patch first, and then applied to the
skin. The patch was fixed with a semi-occlusive dressing.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin served as control.

Amount / concentration applied:

A dose of 0.5 mL ofthe test item was applied to each test site.

Duration of treatment / exposure:

Test item was held in contact with the skin throughout a 4-hour period. At
the end of the exposure period residual test item was removed from the first
animal by using tap water.

Observation period:

Animals were examined for signs of erythema and oedema at 1, 24, 48 and
72 hours after patch removal. For animal No. 2 the observation period was
extended until 7 days after patch removal, when all symptoms had
disappeared.

Number of animals:

3 female animals

Details on study design:

For the determination of classification-relevant values, the animals were
examined for signs of erythema and oedema at 24, 48 and 72 hours after
patch removal.
Individual reactions of each animal were recorded at each observation time.
Nature, severity and duration of all lesions observed were described.
Body weights were recorded at the start and at the end of the study.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean 24 - 72 h

Score:

0.89

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean 24 - 72 h

Score:

0

Irritant / corrosive response data:

Reversibility of any observed effect:
Animal No. 1: No treatment related effects observed.
Animal No. 2: Changes fully reversible within 7 days after patch removal.
Animal No. 3: Changes fully reversible within 72 hours after patch removal.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Considering the reported data of this irritation study it can be stated that the
test item Chloromethyltrimethylsilane showed slight irritant, but no
corrosive effects.
According to the EC criteria for classification and labelling requirements for
dangerous substances and preparations (Guidelines in Commission Directive
93/21 EEC) and GHS criteria (First Revised Edition, 2005) the test item
Chloromethyltrimethylsilane does not have to be classified and has no
obligatory labelling requirement for skin irritation.

Executive summary:

Number of animals: 3

Duration of exposure: 4 hours

Amount of substance: 0.5 mL per test site

Type of dressing: semi-occlusive

Vehicle (moistening): no vehicle used

Reversibility of any observed effect:

Animal No. 1: No treatment related effects observed.

Animal No. 2: Changes fully reversible within 7 days after patch removal.

Animal No. 3: Changes fully reversible within 72 hours after patch removal.

Considering the reported data of this irritation study it can be stated that the

test item Chloromethyltrimethylsilane showed slight irritant, but no

corrosive effects.

According to the EC criteria for classification and labelling requirements for

dangerous substances and preparations (Guidelines in Commission Directive

93/21 EEC) and GHS criteria (First Revised Edition, 2005) the test item

Chloromethyltrimethylsilane does not have to be classified and has no

obligatory labelling requirement for skin irritation.