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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:
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.

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