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Diss Factsheets

Administrative data

Description of key information

In the key study for skin irritation 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine is reported to be corrosive to skin. The study was conducted according to OECD TG 404 and in compliance with GLP (Hazleton, 1990).  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
Study period:
1988-08-05 to 1990-04-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
6 animals used.
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: 2.40 - 2.65 kg
- Housing: individually hosted in polystyrene cages
- Diet: 150 g per rabbit per day of complete pelleted rabbit maintenance diet
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -23
- Humidity (%): 36 - 75 % R.H.
- Air changes (per hr): no data
- 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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml


Duration of treatment / exposure:
3 minutes (group 1) or 4 hours (group 2)
Observation period:
14 days (at 1h, 24h, 48h and 72h)
Number of animals:
6 males per group (2 groups)
Details on study design:
TEST SITE
- Area of exposure: back and flank
- % coverage: no data
- Type of wrap if used: semi-occlusive dressing (perforated adhesive tape, applied on a band of gauze)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 3 minutes or 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosion
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks:
Whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosion
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation.
Remarks on result:
other: corrosive
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosive
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosive
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosive
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The erythema observations of group 1 (3 minutes application) showed that less than a quarter or half of the treated area, in all the individuals, was burnt. Dryness of the treated area could be also observed 72 hours post-treatment. Very slight edema was noted in 4 individuals, within the observation period.

The erythema observations of group 2 (4 hours application) showed that the treated area was necrotic and dry throughout the whole observation period. Slight to moderate edema was reported in most of the individuals within 72 hours post-exposure.
Other effects:
The severe lesions in group 1 (3 minutes application) at 72-hour observation, were reported to be noticeably reversible within 14 days post-application. However, when the test substance was applied for 4 hours to the area in group 2, no reversibility could be observed.
Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
The skin irritation study, conducted according to OECD TG 404 and in compliance with GLP, reports that the substance, 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine, is corrosive.
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

The key study for skin irritation, conducted according to OECD TG 404 and in compliance with GLP, reports that the substance, 1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine, is corrosive to skin (Hazleton, 1990).

Following a 3 minute application of the test material onto rabbit skin, erythema was evident in all the animals, and it was reported that less than a quarter or half of the treated area, in all the individuals, was burnt. Dryness of the treated area could be observed 72 hours post-treatment. The severe lesions at the 72-hour observation point were reported to be noticeably reversible within 14 days post-application. Very slight oedema was noted in 4 out of the 6 rabbits, until the end of the 14 day observation period.

Following the 4 hour exposure, erythema was evident in all the animals, with necrosis and dry skin, until the end of the observation period. Slight to moderate oedema was reported in 5 out of 6 of the animals at 72 hours post-exposure. There was no evidence for reversibility of the lesions, which remained until 14 days after the application of the test material. A reliable supporting study was also available, which reports the test material to be corrosive and supports the findings of the key study (SWS Silicones Corporation, 1976).

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, 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine is classified as Corrosive to Skin Category 1B, 'H314; Causes severe skin burns and eye damage' according to Regulation (EC) 1272/2008.