N,N',N''-tricyclohexyl-1-methylsilanetriamine

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N',N''-tricyclohexyl-1-methylsilanetriamine

EC Number:

240-040-8

EC Name:

N,N',N''-tricyclohexyl-1-methylsilanetriamine

Cas Number:

15901-40-3

Molecular formula:

C19H39N3Si

IUPAC Name:

N,N',N''-tricyclohexyl-1-methylsilanetriamine

Test material form:

other: liquid

Test animals

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible

Results 11

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

Results 12

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.

Applicant's summary and conclusion

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.