3-aminopropyltriethoxysilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

See below

Principles of method if other than guideline:

No guideline is specified. This study approximates in many respects to OECD 404 including observations for 14 days. The neat material (0.5 ml) was held in occlusive contact for 1 h or 3 min with the shaved skin of 6 rabbits. Insufficient details are given on the purity of the test substance, animals used, test site and animal housing conditions.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropyltriethoxysilane

EC Number:

213-048-4

EC Name:

3-aminopropyltriethoxysilane

Cas Number:

919-30-2

Molecular formula:

C9H23NO3Si

IUPAC Name:

silane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no details given
- Age at study initiation: no details given
- Weight at study initiation: no details given
- Housing: no details given
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: no details given

ENVIRONMENTAL CONDITIONS
no details given

IN-LIFE DATES: no details given

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat

Duration of treatment / exposure:

1 h
3 min

Observation period:

14 days

Number of animals:

6 (for each exposure time)
Two animals in the 1-min test were terminated after day 10 for reasons of space.

Details on study design:

TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: gauze covered with loosely held occlusive wrap


REMOVAL OF TEST SUBSTANCE
- Washing: excess removed after exposure
- Time after start of exposure: 1 h; 3 min

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

1-hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

1-hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Remarks:

1-hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

erythema score

Remarks:

1-hour exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Remarks:

1-hour exposure

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

erythema score

Remarks:

1-hour exposure

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

edema score

Remarks:

1-hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Remarks:

1-hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

edema score

Remarks:

1-hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 3 days

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

edema score

Remarks:

1-hour exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

edema score

Remarks:

1-hour exposure

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 12

Irritation parameter:

edema score

Remarks:

1-hour exposure

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 13

Irritation parameter:

erythema score

Remarks:

3-min exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 14

Irritation parameter:

erythema score

Remarks:

3-min exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 15

Irritation parameter:

erythema score

Remarks:

3-min exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 16

Irritation parameter:

erythema score

Remarks:

3-min exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 17

Irritation parameter:

erythema score

Remarks:

3-min exposure

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 18

Irritation parameter:

erythema score

Remarks:

3-min exposure

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 19

Irritation parameter:

edema score

Remarks:

3-min exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 20

Irritation parameter:

edema score

Remarks:

3-min exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 21

Irritation parameter:

edema score

Remarks:

3-min exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 22

Irritation parameter:

edema score

Remarks:

3-min exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 23

Irritation parameter:

edema score

Remarks:

3-min exposure

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 24

Irritation parameter:

edema score

Remarks:

3-min exposure

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1-h occlusive contact caused well-defined to moderate erythema and slight to moderate oedema in all 6 animals, still present at the 3-day observation but not at 7 days. Necrosis that was full thickness in 2/6 and superficial in 2/6 was evident until observation at day 10, but absent at day 14. Ecchymosis (a hemorrhagic area ) was apparent in 4/6 within 2 h but absent by day 2. Scabbing, desquamation or alopecia were still present in all 4 of the remaining animals at termination on day 14. See table 1.
Exposure for 3 min caused slight to well-defined erythema and very slight to slight oedema in 6/6 that remained in some until day 3 but was not evident on day 7. The only other effect reported was desquamation present in 6/6 at the final 7-day observation. See table 2.

Other effects:

None reported.

Any other information on results incl. tables

Tables from the study report with individual scores for each animal can be found under attachments

Table 1: Exposure for 1 hour

Irritant/corrosive response data (mean for 6 animals) at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema & eschar (mean of 6)	Edema (mean of 6)	Other effects (number of animals with each effect shown)
	Max. score: 4	Max. score: 4
2 h	2.3	2.3	2N, 4E
24 h	2.2	2.5	2N+, 2E, 1S
48 h	2.5	2.5	2N+, 1N, 1E, 1S
72 h	2.3	1.5	2N+, 2N, 1D, 1S
Day 7	0.0	0.0	1N+, 2N, 6D, 2S, 3A
Day 10	0.0	0.0	1N+, 6D, 2S, 5A
Day 14 (4 animals)	0.0	0.0	4D, 2S, 4A
Mean 24, 48, 72 h	2.3	2.2	-
Reversibility*	nc
Average time (unit) for reversion	Not fully reversed within 14 days

 

Table 2: Exposure for 3 minutes

Irritant/corrosive response data (mean for 6 animals) at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema & eschar (mean of 6)	Edema (mean of 6)	Other effects (number of animals with each effect shown)
	Max. score: 4	Max. score: 4
2 h	1.5	1.0	-
24 h	1.7	1.2	-
48 h	1.5	0.7	1D
72 h	1.2	0.2	1D
Day 7	0.0	0.0	6D
Mean 24, 48, 72 h	1.5	0.7	-
Reversibility*	nc
Average time (unit) for reversion	Not fully reversed within 7 days

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

N+ = full thickness necrosis

N = superficial necrosis

D = desquamation

E = ecchymosis

S = scab formation

A = alopecia

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

A reliable study, conducted in a manner largely similar to OECD 404, found the neat test material to be corrosive when in occluded contact for 1 h, and a minor to moderate irritant when in contact for 3 min. There is no evidence of GLP status in the report, however, Bushy Run Research Center was a certified GLP laboratory during the period of the conduct of this study.