[No public or meaningful name is available]

Endpoint summary

Description of key information

Study no 01:The Buehler method in guinea pig (guinea pig skin sensitization) was reported to have induced a sensitization response (in 35%) when challenged with a 5% solution when a 20% concentration in peanut oil was applied. A negative and positive compliance control was employed concurrently.
Study no 02: A generally well-conducted, well-reported, guinea-pig maximization test found that the hydrolysis products of 3-aminopropyl(triethoxy)silane (70% in saline) did not elicit a delayed contact hypersensitivity response in guinea pigs. Appropriate concurrent negative and positive compliance controls were included and the expected responses were observed.
Study no03: A generally well-conducted, well-reported, guinea-pig maximization test found that the hydrolysis products of 3-aminopropyltriethoxysilane (CAS 919-30-2)silane (50% aqueous) did not elicit a delayed contact hypersensitivity response in guinea pigs. Observed were appropriate negative and positive compliance controls concurrently in operation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data was taken from secondary sources

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

1987

Principles of method if other than guideline:

Skin Sensitisation guideline OECD 406
- Principle of test: Skin senistisation test were carrierd out to determind the erythma and edema score, ny buhlers test
- Short description of test conditions: Erythma and Edema score were noted
- Parameters analysed / observed:

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon.

Specific details on test material used for the study:

Not specified

Species:

guinea pig

Strain:

not specified

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified] No data available
- Microbiological status of animals, when known: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
- Indication of any skin lesions: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C):No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
- IN-LIFE DATES: From: To: No data available

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

Induction .5 % intracutaneous
Induction 50 % open epicutaneous
Challenge 50 % open epicutaneous

Day(s)/duration:

Not specified

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

INDUCTION
intradermal: 0.5%
dermal: 50%
CHALLENGE
dermal: 50%

Day(s)/duration:

not specified

Adequacy of challenge:

not specified

No. of animals per dose:

test: 20
negative controls: 10
positive controls: 20 test; 10 control

Details on study design:

1st: Induction .5 % intracutaneous
2nd: Induction 50 % open epicutaneous
3rd: Challenge 50 % open epicutaneous

Positive control substance(s):

not specified

Reading:

other: 24h 48 h

Group:

negative control

Dose level:

50% aqueous

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Not specified

Remarks on result:

no indication of skin sensitisation

Reading:

other: 24h 48 h

Group:

test chemical

Dose level:

50% aqueous

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Not specified

Remarks on result:

no indication of skin sensitisation

No adverse skin reactions were noted at the test material or vehicle control sites of the test or control animals at the 24 or 48 h observations. 

 

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

A generally well-conducted, well-reported, guinea-pig maximization test found that the hydrolysis products of 3-aminopropyltriethoxysilane (CAS 919-30-2)silane (50% aqueous) did not elicit a delayed contact hypersensitivity response in guinea pigs. Observed were appropriate negative and positive compliance controls concurrently in operation.

Executive summary:

In accordance with the test guideline 406 Acute skin sensitization test, the RA chemical  3 aminopropyltriethoxysilane  ( CAS number: 919-30-2)was studied using a guinea pig (Guinea pig maximization test).

In the induction group, the test sample was applied through intradermal and epicutaneous routes at a concentration range of Induction .5 % intracutaneous, Induction 50 % open epicutaneous, and Challenge 50 % open epicutaneous. using water as a vehicle.

After 24h and 48 hrs of observation in the test chemical group at 50% aqueous group skin sensations was not observed, similar for negative test group No adverse skin reactions were noted at the test material or vehicle control sites of the test or control animals at the 24 or 48 h observations. 

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data was taken from another source

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

1995

Principles of method if other than guideline:

Skin Sensitisation guideline OECD 406
- Principle of test: Skin senistisation test were carrierd out to determind the erythma and edema score, ny buhlers test
- Short description of test conditions: Erythma and Edema score were noted
- Parameters analysed / observed:
The full report gives various references for the method, including Magnusson & Kligman 1969. This is of course the reference also given in OECD 406.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon.

Specific details on test material used for the study:

Not specified

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source:Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified]
- Microbiological status of animals, when known:
- Age at study initiation: four to six weeks
- Weight at study initiation:300 - 372 grams
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
- Indication of any skin lesions: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light):No data available
- IN-LIFE DATES: From: To:No data available

Route:

intradermal and epicutaneous

Vehicle:

physiological saline

Concentration / amount:

INDUCTION
Intradermal: 0.25%
dermal: 70%
CHALLENGE
dermal: 70%

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

physiological saline

Concentration / amount:

INDUCTION
Intradermal: 0.25%
dermal: 70%
CHALLENGE
dermal: 70%

Day(s)/duration:

24hrd

Adequacy of challenge:

not specified

No. of animals per dose:

test and vehicle control: 10/sex
positive control: 3/sex

Details on study design:

1st application: Induction 0.25 % intracutaneous
2nd application: Induction 70 % occlusive epicutaneous
3rd application: Challenge 70 % occlusive epicutaneous

Challenge controls:

Not specified

Positive control substance(s):

not specified

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

70% saline solution

No. with + reactions:

1

Total no. in group:

20

Clinical observations:

reactions: grade 1

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

70% saline

No. with + reactions:

5

Total no. in group:

20

Clinical observations:

reactions: grade 1

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

70% saline

No. with + reactions:

1

Total no. in group:

20

Clinical observations:

reactions: grade 1

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

70% in saline

No. with + reactions:

4

Total no. in group:

20

Clinical observations:

reactions: grade 1

Remarks on result:

no indication of skin sensitisation

All animals gained weight and survived to study termination. No positive responses were observed at 24 hours or 48 hours in the test group receiving test article at a 70% concentration in saline, that were greater than those in the vehicle control group. No responses were observed at any vehicle treated site. The positive control animals induced and challenged with DNCB exhibited the anticipated responses at challenge, indicating a reliable and valid test.

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

A generally well conducted, well reported, guinea-pig maximization test found that the hydrolysis products of 3-aminopropyl(triethoxy)silane (70% in saline) did not elicit a delayed contact hypersensitivity response in guinea pigs. Appropriate concurrent negative and positive compliance controls were included and the expected responses observed.

Executive summary:

In accordance with the test guideline 406 Acute skin sensitization test, the RA chemical  3 aminopropyltriethoxysilane ( CAS number: 919-30-2)was studied using a guinea pig (Guinea pig maximization test).

All animals gained weight and survived to study termination. No positive responses were observed at 24 hours or 48 hours in the test group receiving the test article at a 70% concentration in saline, that were greater than those in the vehicle control group. No responses were observed at any vehicle-treated site. The positive control animals induced and challenged with DNCB exhibited the anticipated responses at a challenge, indicating a reliable and valid test.

A generally well-conducted, well-reported, guinea-pig maximization test found that the hydrolysis products of 3-aminopropyl(triethoxy)silane (70% in saline) did not elicit a delayed contact hypersensitivity response in guinea pigs. Appropriate concurrent negative and positive compliance controls were included and the expected responses observed.

Since the test article readily hydrolyzes in saline, the test was actually conducted on the hydrolysis products of the test material.
Appropriate concurrent negative and positive compliance controls were included and the expected responses were observed. Under the conditions of this study, the hydrolysis products of gamma-aminopropyltriethoxysilane did not elicit a delayed contact hypersensitivity response in
guinea pigs

Reference 3

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Remarks:

Guinea pig maximization test

Adequacy of study:

weight of evidence

Study period:

Not specified

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data was taken from secondary sources

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

According to SIAR, 2003

Principles of method if other than guideline:

Skin Sensitisation guideline OECD 406
- Principle of test: Skin senistisation test were carrierd out to determind the erythma and edema score, ny buhlers test
- Short description of test conditions: Erythma and Edema score were noted
- Parameters analysed / observed:

GLP compliance:

not specified

Type of study:

Buehler test

Justification for non-LLNA method:

An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon.

Specific details on test material used for the study:

Not specified

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified] No data available
- Microbiological status of animals, when known:
- Age at study initiation: four weeks
- Weight at study initiation: 308 - 400 grams.
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
- Indication of any skin lesions: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light):No data available
- IN-LIFE DATES: From: To: No data available

Route:

epicutaneous, occlusive

Vehicle:

peanut oil

Concentration / amount:

Induction 20 % occlusive epicutaneous
Challenge 5 % occlusive epicutaneous

Day(s)/duration:

7 days

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

peanut oil

Concentration / amount:

induction: 20%
challenge: 5%

Day(s)/duration:

Not specified

Adequacy of challenge:

not specified

No. of animals per dose:

test group: 10/sex
negative control: 5/sex
positive control: 3/sex

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6hrs
- Test groups: 10 males, 10 females
- Control group : vehicle: 5 males, 5 females; positive: 3 males, 3 females
- Frequency of applications: 7-days between applications
- Duration:
- Concentrations: test groups 20% TS in peanut oil; positive control 0.3% DNCB in 80% ethanol

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: challenge exposure 14 days following last induction
- Exposure period: 6hrs
- Test groups: 10 males, 10 females
- Control group: vehicle: 5 males, 5 females; positive: 3 males, 3 females
- Site: test group TS 5% left flank; vehicle control group TS 5% left flank, vehicle right flank; positive control group DNCB 0.02% left flank, 0.2% right flank
- Concentrations:test group 5% TS in peanut oil; vehicle control 5% TS in peanut oil; positive control 0.02 and 0.2% DNCB in acetone
- Evaluation (hr after challenge): 24 and 48h

OTHER:

Challenge controls:

vehicle control group: 5/sex

Positive control substance(s):

yes

Remarks:

1-chloro-2,4-dinitrobenzene (DNCB)

Positive control results:

The sensitization incidence index of 100% from tests with the know n sensitizer DNCB at 0.2% confirms the validity of the test method.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

Peanut oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Not specified

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

0.02%DNCB

No. with + reactions:

1

Total no. in group:

6

Clinical observations:

Not specified

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

48

Group:

positive control

Dose level:

0.02% DNCB

No. with + reactions:

0

Total no. in group:

6

Clinical observations:

Not specified

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

0.2% DNCB

No. with + reactions:

6

Total no. in group:

6

Clinical observations:

Not specified

Remarks on result:

positive indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5%

No. with + reactions:

7

Total no. in group:

20

Clinical observations:

slight or moderate erythema

Remarks on result:

positive indication of skin sensitisation

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5%

No. with + reactions:

3

Total no. in group:

20

Clinical observations:

Slight erythema

Remarks on result:

positive indication of skin sensitisation

GROUP	MATERIAL	INTERVAL	DERMAL SCORES*					SENSITIZATION INCIDENCE INDEX**	SEVERITY INDEX***
			0	±	1	2	3
Test	TS 5%	24h	14/20	3/20	3/20	0/20	0/20	3/20	0.2
		48h	4/20	9/20	3/20	4/20	0/20	7/20	0.8
Positive control	DNCB 0.2%	24h	0/6	0/6	1/6	3/6	2/6	6/6	2.2
		48h	0/6	0/6	1/6	3/6	2/6	6/6	2.2
	DNCB 0.02%	24h	2/6	4/6	0/6	0/0	0/0	0/6	0.3
		48h	0/6	5/6	1/6	0/0	0/0	1/6	0.6
Vehicle control	TS 5%	24h	9/10	1/10	0/10	0/10	0/10	0/10	0.1
		48h	7/10	2/10	1/10	0/10	0/10	1/10	0.2
	Peanut oil	24h	10/10	0/10	0/10	0/10	0/10	0/10	0
		48h	10/10	0/10	0/10	0/10	0/10	0/10	0

 

Table 1: Incidence of dermal response to challenge dosing

*Skin reactions were graded:

0 no reaction or very slight dispersed redness. No swelling.

± slight patchy erythema (equates to a score of 0.5)

1 slight confluent or moderately patchy erythema

2 moderate erythema

3 severe erythema with or without edema

** Sensitization incidence index: number of animals with dermal scores greater than those of the negative control group at 24h or 48h, divided by the number of animals tested. Grades of 1 or greater are considered indicative of sensitization in the positive control group.

There were no signs of systemic toxicity during the study. All animals gained weight during the study and there was no significant test -article-related differences in vehicle and test group mean body weight.

No positive responses were observed in the peanut oil control animals at either the vehicle or test article sites at the 24-hour grading. In the peanut oil control animals at the 48-hour grading one animal exhibited a positive response at the test article site, a grade of one (1). Of the twenty animals induced with the test article at 20% and challenged at 5%, three animals were observed with a positive response of one (1) at the 24-hour grading, and three exhibited a positive response of one (1) and four exhibited a positive response of two (2) at the 48-hour grading. The positive control animals induced and challenged with DNCB exhibited the anticipated responses at the challenge, indicating a reliable and valid test.

Interpretation of results:

other: Not classified

Conclusions:

The Buehler method in guinea pig (guinea pig skin sensitization) was reported to have induced a sensitization response (in 35%) when challenged with a 5% solution when a 20% concentration in peanut oil was applied. A negative and positive compliance control was employed concurrently.

Executive summary:

In accordance with the test guideline 406 Acute skin sensitization test, the RA  chemical  3 aminopropyltriethoxysilane (CAS number: 919-30-2)was studied using a guinea pig (Guinea pig maximization test).

There were no signs of systemic toxicity during the study. All animals gained weight during the study and there was no significant test -article-related differences in vehicle and test group mean body weight.

No positive responses were observed in the peanut oil control animals at either the vehicle or test article sites at the 24-hour grading. In the peanut oil control animals at the 48-hour grading, one animal exhibited a positive response at the test article site, a grade of one (1). Of the twenty animals induced with the test article at 20% and challenged at 5%, three animals were observed with a positive response of one (1) at the 24-hour grading, and three exhibited a positive response of one (1) and four exhibited a positive response of two (2) at the 48-hour grading. The positive control animals induced and challenged with DNCB exhibited the anticipated responses at the challenge, indicating a reliable and valid test. Hence the chemical can fall under the unclassified category as per the GHS classification 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Study no 01:

In accordance with the test guideline 406 Acute skin sensitization test, the RA  chemical  3 aminopropyltriethoxysilane (CAS number: 919-30-2)was studied using a guinea pig (Guinea pig maximization test). There were no signs of systemic toxicity during the study. All animals gained weight during the study and there was no significant test -article-related differences in vehicle and test group mean body weight.No positive responses were observed in the peanut oil control animals at either the vehicle or test article sites at the 24-hour grading. In the peanut oil control animals at the 48-hour grading, one animal exhibited a positive response at the test article site, a grade of one (1). Of the twenty animals induced with the test article at 20% and challenged at 5%, three animals were observed with a positive response of one (1) at the 24-hour grading, and three exhibited a positive response of one (1) and four exhibited a positive response of two (2) at the 48-hour grading. The positive control animals induced and challenged with DNCB exhibited the anticipated responses at the challenge, indicating a reliable and valid test. Hence the chemical can fall under the unclassified category as per the GHS classification.

Study no 02:

In accordance with the test guideline 406 Acute skin sensitization test, the RA chemical  3 aminopropyltriethoxysilane ( CAS number: 919-30-2)was studied using a guinea pig (Guinea pig maximization test). All animals gained weight and survived to study termination. No positive responses were observed at 24 hours or 48 hours in the test group receiving the test article at a 70% concentration in saline, that were greater than those in the vehicle control group. No responses were observed at any vehicle-treated site. The positive control animals induced and challenged with DNCB exhibited the anticipated responses at a challenge, indicating a reliable and valid test. A generally well-conducted, well-reported, guinea-pig maximization test found that the hydrolysis products of 3-aminopropyl(triethoxy)silane (70% in saline) did not elicit a delayed contact hypersensitivity response in guinea pigs. Appropriate concurrent negative and positive compliance controls were included and the expected responses were observed. Since the test article readily hydrolyzes in saline, the test was actually conducted on the hydrolysis products of the test material.
Appropriate concurrent negative and positive compliance controls were included and the expected responses were observed. Under the conditions of this study, the hydrolysis products of gamma-aminopropyltriethoxysilane did not elicit a delayed contact hypersensitivity response in guinea pigs.

Study no 03:

In accordance with the test guideline 406 Acute skin sensitization test, the RA chemical  3 aminopropyltriethoxysilane  ( CAS number: 919-30-2)was studied using a guinea pig (Guinea pig maximization test).In the induction group, the test sample was applied through intradermal and epicutaneous routes at a concentration range of Induction .5 % intracutaneous, Induction 50 % open epicutaneous, and Challenge 50 % open epicutaneous. using water as a vehicle. After 24h and 48 hrs of observation in the test chemical group at 50% aqueous group skin sensations were not observed, similar to the negative test group No adverse skin reactions were noted at the test material or vehicle control sites of the test or control animals at the 24 or 48 h observations. 

Justification for classification or non-classification

Based on the all the above studies of the RA chemical, it may conclude that the given test chemical which has the same structure as that of RA can belong to the unclassified category as per CLP criteria of GHS classification