Registration Dossier

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Administrative data

Description of key information

Skin sensitisation (OECD 406), Buehler: sensitizer Cat. 1B (RA from CAS 919-30-2)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
No experimental skin sensitization data is available for the registered substance 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine (CAS 13497-18-2). A worst-case read-across approach is adopted using 3-Aminopropyl(triethoxy)silane (CAS 919-30-2) as the source substance. 3-Aminopropyl(triethoxy)silane is classified as a Cat. 1B skin sensitizer and is present as an impurity in 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine at >1%, therefore, as a worst-case assumption, 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine is also classified as a Cat. 1B skin sensitizer.

This is an interim approach and experimental testing on 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine is planned. The dossier will be updated accordingly when this data becomes available.
Reason / purpose for cross-reference:
read-across source
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
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 to moderate erythema
Remarks on result:
positive 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
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.2% DNCB
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.02% DNCB
No. with + reactions:
0
Total no. in group:
6
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
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Peanut oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Peanut oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
A well conducted, well reported guinea-pig skin sensitization test (Buehler method) on the source substance reported that a 20% concentration of the test material in peanut oil induced a sensitization response (in 35%) when challenged with a 5% solution. Appropriate concurrent negative and positive compliance controls were included.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No experimental skin sensitization data is available for the registered substance 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine (CAS 13497-18-2). A worst-case read-across approach is adopted using 3-Aminopropyl(triethoxy)silane (CAS 919-30-2) as the source substance. 3-Aminopropyl(triethoxy)silane is classified as a Cat. 1B skin sensitizer and is present as an impurity in 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine at >1%, therefore, as a worst-case assumption, 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine is also classified as a Cat. 1B skin sensitizer.


The key study for skin sensitisation (3-Aminopropyl(triethoxy)silane, Pharmakon, 1997), conducted according to OECD Test Guideline 406 and in compliance with GLP, reports that 20% concentration of the test material in peanut oil induces a sensitisation response in 35% of the test animals, in response to a 5% challenge dose. Appropriate concurrent negative and positive compliance controls were included in the study.


 


In conclusion, based on the available data from the source substance it was concluded that 3-(triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine is classified as a skin sensitizer, Cat. 1B.


 


This is an interim approach and experimental testing on 3-(Triethoxysilyl)-N-[3-(triethoxysilyl)propyl]-1-propanamine is planned. The dossier will be updated accordingly when this data becomes available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Study not required according to Annex VII-X of Regulation (EC) No. 1907/2006.

Justification for classification or non-classification

Based on the information from the read-across substance, it is concluded the test substance meets the criteria for classification as “Skin sensitizer, category 1B” with the hazard statement “May cause an allergic skin reaction (H317)” according to Regulation (EC) No. 1272/2008.