Registration Dossier

Administrative data

Description of key information

In the key skin sensitisation study, conducted according to OECD Test Guideline 406 (Buehler method) and in compliance with GLP, (3-chloropropyl)trimethoxysilane was not sensitising to skin (Hüls, 1993e).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
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. Please refer to the attached document for further details.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Hartley, Pinbright White Bor:DHPW [SPF]
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
No. of animals per dose:
20 test animals and 10 control
Details on study design:
1st application: Induction 100 % occlusive epicutaneous
2nd application: Challenge 100 % occlusive epicutaneous

In the definitive test, a test group of 20 animals was induced with 100% test substance on days 0, 7 and 14 and subsequently challenged with 100% test substance on day 28. A control group of 10 animals was induced and challenged with MEH 56 corn oil.
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-dinitrobenzene
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1-Chloro-2,4-dinitrobenzene
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1-Chloro-2,4-dinitrobenzene
Remarks on result:
positive indication of skin sensitisation

There were no substance related effects or influence on body weight in either test or control animals. There was no erythema or edema observed during Induction Phases I, II or III; no skin irritation was observed in the control animals.
There was no skin irritation observed in either test or control animals in the Challenge Phase.

Interpretation of results:
GHS criteria not met
Conclusions:
In a guideline study (Buehler method), conducted in compliance with GLP, (3-chloropropyl)trimethoxysilane was not sensitising.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the key skin sensitisation study, conducted in according to OECD Test Guideline 406 (Buehler method) and in compliance with GLP, (3-chloropropyl)trimethoxysilane was concluded to be not sensitising to skin (Hüls, 1993e).

At the induction phase, a group of 20 guinea pigs was induced by epicutaneous occlusive application of 100% (3-chloropropyl)trimethoxysilane on study days 0, 7 and 14. A control group of 10 animals was induced in the same way as the test group but with the vehicle, corn oil.

Challenge was performed two weeks following the last induction application, on study day 28. During challenge 100% (3-chloropropyl)trimethoxysilane in corn oil was applied epicutaneously under occlusive dressing. A control group of 10 animals was challenged in the same way as the test group but with the vehicle, corn oil.

No erythema or oedema was observed during Induction Phases I, II or III. No skin irritation was observed in any of the control animals. There was no skin irritation observed in either the test or control animals during the challenge phase. There were no other substance-related effects or body weight effects in either the test or control animals. The positive control substance, 1-chloro-2,4-dinitrobenzene, gave the expected results.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data are available regarding respiratory sensitisation.

Justification for classification or non-classification

Based on the available information, (3-chloropropyl)trimethoxysilane is not classified for skin sensitisation according to Regulation (EC) No 1272/2008.