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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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.

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.