[No public or meaningful name is available]

Skin sensitisation

Administrative data

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

Data source

Reference

Reference Type:

other: Secondary source

Title:

SIDS Initial Assessment Report For SIAM 17 OECD SIDS SIAM,2003 OECD SIDS

Author:

OECD SIDS

Year:

2003

Bibliographic source:

OECD SIDS SIAM,2003

Materials and methods

Test guideline

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.

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:

3-AMINOPROPYLTRIETHOXYSILANE

Test material form:

liquid

Specific details on test material used for the study:

Not specified

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

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

Challenge

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

Results and discussion

In vivo (non-LLNA)

Results

Results 1

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

Results 2

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

Any other information on results incl. tables

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. 

 

Applicant's summary and conclusion

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.