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Description of key information

In the key study for skin irritation, N,N',N''-tricyclohexyl-1-methylsilanetriamine is reported to be corrosive following a 3 minute exposure period, based on the criteria of EEC 84/449 Annex V Method B4 (Hazleton, 1990). The supporting study reported the substance to be corrosive following a 4 hour exposure period, based on reported destruction of the skin tissue described as third degree chemical burns (SWS Silicones Corporation, 1976).  

In accordance with Column 2 of REACH Annex VIII, the in vivo eye irritation study (required in Section 8.2.1) does not need to be conducted as the substance is classified as corrosive to skin.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: adult
- Weight at study initiation: 250-270 g
- Housing: individually in polystyrene cages
- Diet: 150 g per animal per day of complete pelleted rabbit maintenance diet
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 38-75
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
3 minutes
Observation period:
Cutaneous examinations were performed at 1, 24, 48 and 72 hours post-treatment.
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: back and flanks
- % coverage: 14 cm x 14 cm
- Type of wrap if used: The test article and the gauze square were held in contact with the skin by mean of semi-occlusive dressing: perforated adhesive tape applied onto a band of crepe gauze.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 3 minutes

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Well defined erythema was observed in 5 out of 6 animals at 1 hour after removal of the test material. One animal had slight erythema.
Burnt aspect of the exposure area was observed at 24 hours in 5 out of 6 animals. One animal had well defined erythema.
Burnt aspects and dryness of the exposure area was evident at 48 and 72 hours post-treatment in 4 out of 6 animals. One animal exhibited only burnt aspect and another well defined erythema.
Other effects:
One animal was found dead before the end of the 14-day study period. Reversability of the corrosive effects were not confirmed.
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
Based on the available information from the key skin irritation/corrosion study for N,N',N''-tricyclohexyl-1-methylsilanetriamine, the test material is reported to be corrosive to skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key study for skin irritation, N,N',N''-tricyclohexyl-1-methylsilanetriamine is reported to be corrosive following a 3 minute exposure period, based on the criteria of EEC 84/449 Annex V Method B4 (Hazleton, 1990).

Following a 3 minute application of the test material onto the intact skin of six rabbits, the study authors reported erythema scores of 3.33 at 24 hours, 3.67 at 72 hours, 3.5 on day 7 and 2.2 on day 14. Oedema was also observed in all the animals. The study reports necrosis followed by eschar formation in two of the rabbits (day 7). One of these two test animals died of diarrhoea before the end of the study. What are described as "burnt aspect" is described for in three of the other animals on day seven and in three out of five surviving animals on day 14.

The supporting study reported the substance to be corrosive following a 4 hour exposure period, based on reported destruction of the skin tissue described as third degree chemical burns (SWS Silicones Corporation, 1976). Following 4-hour application of the test material onto a rabbit skin, the study authors report the primary irritation score for the test material to be 8 (the maximum score), indicating third degree chemical burns. Erythema and oedema were observed in all the animals with the maximum reaction score of 4. Necrosis and eschar were also observed in all the animals.

In accordance with Column 2 of REACH Annex VIII, the in vitro eye irritation study (required in Section 8.2.1) does not need to be conducted as the substance is classified as corrosive to skin.


Justification for classification or non-classification

Based on the available data, N,N',N''-tricyclohexyl-1-methylsilanetriamine is classified as Corrosive to Skin Category 1A, 'H314; Causes severe skin burns and eye damage' according to Regulation (EC) No 1272/2008.

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