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Diss Factsheets

Administrative data

Description of key information

The key in vivo skin irritation study was conducted according to OECD Test Guideline 404 and in compliance with GLP (Hüls, 1998c, reliability score 1) and concluded tetramethylsilane (CAS No. 75 -76 -3, EC No. 200-899 -1) was not irritating to rabbit skin.

The key in vivo eye irritation study was conducted according to OECD Test Guidelines 405 and in compliance with GLP (Hüls, 1998d, reliability score 1) and concluded tetramethylsilane was not an irritant to the eyes of rabbits.

Reliable data were available from OECD 404 and 405 Test Guideline studies for tetramethylsilane and therefore additional in vitro testing for this endpoint is not required.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997/12/01-1997/12/05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: White New Zealand albino, HsdPoc:NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Source: Harlan, Winkelmann GmbH, 33176 Borchen, Gartenstrasse 27

- Age at study initiation: young adults

- Weight at study initiation: 2.6-3 kg

- Housing: Conventional, single housing in stainless steel cages

- Diet: Ssniff K 4 complete feed for rabbits, ad libitum. Supplied by Ssniff, Spezialfutter GmbH, 59494 Soest

- Water: Tap water, ad libitum

- Acclimation period: minimum of 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20 +/- 3

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped, intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 cm3

- Concentration (if solution):undiluted

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3M
Details on study design:
TEST SITE

- Area of exposure: not specified

- coverage: 6 cm2

- Type of wrap if used: the area of exposure was covered with gauze patch which was secured in place with a non irritant plaster. The patch was held in contact with the skin by a suitable semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): with warm water

- Time after start of exposure:4 hours


SCORING SYSTEM: According to OECD
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The exposure to test substance caused no skin reaction in 2 animals 30-60 min after removal of the dressing. One animal showed very slight erythema and oedema after 1 hour. No skin reactions were observed in any animals 24 to 72 hours after patch removal.
Other effects:
None reported.

All scores were zero at all time points after patch removal, except for in one animal in which the score was 1 at 1 hour for erythema and eschar and oedema formation.

Interpretation of results:
GHS criteria not met
Conclusions:
In a reliable study conducted according to an appropriate test protocol, and in compliance with GLP, tetramethylsilane was found to be non-irritant to rabbit skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998/01/19-1998/01/23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Harlan, Winkelmann GmbH, 33176 Borchen, Gartenstrasse 27

- Age at study initiation: adult animals

- Weight at study initiation: 2.6-3.1 kg

- Housing: conventional, single housing in stainless steel cages

- Diet: Ssniff K 4 complete feed for rabbits, ad libitum. Supplied by Fa. Gelsenwasser, Wasserwerk, 45721 Haltern

- Water: Tap water, ad libitum

- Acclimation period:minimum 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20 +/- 3

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 cm3

- Concentration (if solution): undiluted

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): with warm physiological saline

- Time after start of exposure: 24 and 48 h


SCORING SYSTEM: According to OECD


TOOL USED TO ASSESS SCORE: hand-slit lamp/ fluorescein
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The administration of the test substance caused, within one hour, some definitely hyperaemic (injected) blood vessels in all three animals. No irritation of the eye and mucous membranes occured in any of the animals 24 to 72 hours after administration of the test substance.
Other effects:
None reported.

All scores were zero at all times other than at 1 hour, when the score for conjunctival redness was 1 for all three animals.

Interpretation of results:
GHS criteria not met
Conclusions:
In a reliable study conducted according to the appropriate OECD test guideline and in compliance with GLP, tetramethylsilane was not found to be irritanting to rabbit eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key skin and eye irritation studies are the only data available for these endpoints (Hüls, 1998c and Hüls, 1998d, reliability score 1). They were conducted in accordance with the appropriate OECD test guidelines and in compliance with GLP.

In the skin irritation study, a single application (0.5 cm3) of the liquid test substance was applied to the clipped, intact skin of three male New Zealand rabbits for an exposure period of 4 hours. The administration of the test substance caused no skin reactions 24, 48 and 72 hours after removal of the patch.

In the eye irritation study, a single application of undiluted test material (0.1 cm3) was administered to the conjunctival sac of one eye in three female rabbits for 24 hours. The mean individual 24/48/72-hour scores were zero for conjunctival redness, conjunctival chemosis, iris and corneal irritation. There were no signs of systemic toxicity or mortality throughout the study and the test substance was concluded to be not irritating to the eyes of rabbits.

Justification for classification or non-classification

Based on reliable in vivo data, tetramethylsilane is not classified as irritating to skin or eyes according to Regulation (EC) No 1272/2008.