Triethoxy(3-isocyanatopropyl)silane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 August 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The restrictions were (i) scoring of animals not provided (ii) occlusive patch used (semi-occlusive recommended).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(scoring of animals not provided; occlusive patch used (semi-occlusive recommended))

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(3-isocyanatopropyl)silane

EC Number:

246-467-6

EC Name:

Triethoxy(3-isocyanatopropyl)silane

Cas Number:

24801-88-5

Molecular formula:

C10H21NO4Si

IUPAC Name:

triethoxy(3-isocyanatopropyl)silane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HRP, Inc., Denver, PA
- Age at study initiation: ~ 13 to 18 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: no data available
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 61 to 70 °F [16-21 °C]
- Humidity (%): 40 to 70%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: ~ 1 April 1994 To: 6 May 1994

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

3 minutes or 1 hour

Observation period:

14 days (reading at 1, 24, 48 and 72 hours, and at 7 and 14 days)

Number of animals:

1/sex given 1-hour treatment
3/sex given 3-minute treatment

Details on study design:

TEST SITE
- Area of exposure: 1-inch square (~6 cm2)
- % coverage: no data available
- Type of wrap if used: gauze patch secured by adhesive tape, and polyethylene sheet around trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed

SCORING SYSTEM:
As per OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

1-hour exposure period

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

1-hour exposure period

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

1-hour exposure period

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #5

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #6

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Remarks on result:

positive indication of irritation

Results 12

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Remarks on result:

positive indication of irritation

Results 13

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Remarks on result:

positive indication of irritation

Results 14

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #5

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Remarks on result:

positive indication of irritation

Results 15

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #6

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

After three minutes of contact, severe oedema was seen in all rabbits 1 to 24 hours after exposure. Moderate to severe oedema was observed between 1 and 48 hours. Two rabbits developed superficial necrosis by one hour, and the remaining developed superficial necrosis by day 14. All rabbits developed ecchymoses by 72 hours, which subsided by day 14. All rabbits had desquamation and 5/6 had alopecia by day 14. Also observed were tan discolouration (3/6 rabbits by day 7), fissures (4/6 rabbits by day 14) and scab formation (1 rabbit at day 14).

After one hour of contact, severe oedema with moderate erythema was seen in both rabbits within the first hour of exposure. Erythema was severe within 48 hours. Ecchymoses were observed in both rabbits at 24 and 48 hours. Superficial necrosis and fissures were apparent on both rabbits by day 7. By day 9, superficial necrosis progressed to full thickness necrosis on the female rabbit. Necrosis persisted for 14 days in both rabbits. Desquamation, scabs and alopecia were observed on each animal on day 14.

Any other information on results incl. tables

The test material was clearly corrosive based on the description given.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

In a GLP study performed according to OECD Test Guideline 404, undiluted triethoxy(3-isocyanatopropyl)silane was corrosive to the skin of rabbits when applied for one hour.

Executive summary:

In an acute dermal irritation/corrosion study carried out to GLP and according to OECD Test Guideline 404, rabbits were exposed dermally to triethoxy(3-isocyanatopropyl)silane.

0.5 ml undiluted triethoxy(3-isocyanatopropyl)silane was applied under occlusion to the clipped, intact skin of groups of rabbits for three minutes (3 animals/sex) or for one hour (1 animal/sex). Animals were then observed at 1, 24, 48 and 72 hours, and at 7 and 14 days.

Moderate to severe irritation were seen after 1-48 hours in all rabbits given three-minute applications. Superficial necrosis was seen in two animals after 2 hours and in all six by 14 days; it did not develop to full thickness necrosis. Other effects included alopecia, tan discolouration, fissures and scab formation. Hour-long treatments resulted in severe irritation, including severe erythema and ecchymoses [haemorrhagic spots], in both animals by 48 hours. Superficial necrosis and fissures were present in both rabbits by day 7 and developed to full thickness necrosis in one rabbit by 14 days. Desquamation, scabs and alopecia were seen in both animals at 14 days.

Under these experimental conditions, undiluted triethoxy(3-isocyanatopropyl)silane was corrosive to the skin of rabbits when applied for one hour.