N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 March 2003 to 26 March 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

445-890-5

EC Name:

-

Cas Number:

201290-01-9

Molecular formula:

C14H37NO2Si3

IUPAC Name:

7-ethoxy-2,2,7-trimethyl-3-(trimethylsilyl)-8-oxa-3-aza-2,7-disiladecane

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: the test material was used undiluted

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was used undiluted. The absorption of the test material was not determined.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet: Certified Rabbit Diet, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): the test material was applied undiluted

NEGATIVE CONTROL: not applicable

POSITIVE CONTROL: not applicable

Duration of treatment / exposure:

Animal No. 1: 3 minutes, 1 hour and 4 hours
Animal No. 2 and 3: 4 hours

Observation period:

1 hour, 24, 48 and 72 hours after patch removal and an additional observation on day 7.

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: dorsal/ flank area
- % coverage: no data
- Type of wrap if used: the test material was introduced under 2.5 cm x 2.5 cm cotton gauze patch and secured in position with a strip of surgical adhesive tape. An elastic corset was used to prevent the animals interfering with the patches.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in a suitable solvent.
- Time after start of exposure: One rabbit was initially treated and three patches of test material were applied. One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours.

OBSERVATION TIME POINTS
One rabbit was initially treated and three patches of test material were applied on the dorsal area. One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours. After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 ml of test material. One patch was applied to the back of each rabbit and was allowed to remain in contact with the skin for 4 hours. The test sites were examined for primary irritation at 1 hour, 24, 48 and 72 hours after patch removal.

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

4 hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Remarks:

4 hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Remarks:

4 hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Remarks:

4 hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Remarks:

4 hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Remarks:

4 hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.75

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

erythema score

Remarks:

1-hour exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Results 8

Irritation parameter:

edema score

Remarks:

1-hour exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

4-hour exposure period: Well-defined erythema and very slight to slight oedema were noted at all treated skin sites one hour after patch removal and at the 24-hour observation period with very slight erythema and very slight oedema at all treated skin sites at the 48 and 72-hour observations. Loss of skin elasticity was noted at all treated skin sites at the 72-hour observations. All treated skin sites appeared normal on day 7.
1-hour exposure period: very slight erytheme and very slight oedema were noted at 1 hour after patch removal. Very slight erythema was still evident at 24 hours post-treatment. The treated skin site appeared normal at the 48-hour observation.
3-minute exposure period: Very slight erythema was noted at the treated skin site one hour after patch removal. All the treated skin sites appeared normal by 24 hours post-exposure.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the skin irritation study, conducted according to OECD TG 404 and in compliance with GLP, the test item, N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane, was reported to be a mild irritant to rabbit skin, however it did not meet the criteria for classification according to GHS and Regulation (EC) No. 1272/2008.