Registration Dossier

Administrative data

Description of key information

Skin sensitisation (OECD 406), Buehler test: not sensitising (RA from CAS 116912-64-2)

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:
Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%, challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Induction: 100%, challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%, challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Induction: 100%, challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects observed
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In a Buehler Test conducted to GLP and OECD 406 the source substance was not sensitising to the skin. As explained in the analogue justification, the differences in molecular structure between the target and the source are unlikely to lead to differences in the skin sensitisation potential.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data on skin sensitisation of [3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3) are available. Therefore, the risk assessment was performed based on the available data from the source substance ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2). The source substance is the reaction mass of [3-(trimethoxysilyl)propyl]urea, [3-(dimethoxyethoxysilyl)propyl]urea, [3-(methoxydiethoxysilyl)propyl]urea and [3-(triethoxysilyl)propyl]urea and therefore contains the target substance as one of its components. In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and in accordance with the Read across assessment framework (RAAF, ECHA 2017) read across from the analogue substance has been applied to support the human health hazard assessment of [3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.

Skin sensitisation

The skin sensitising properties of CAS 116912-64-2 were tested in a study according to OECD TG 406 under GLP conditions using the test for delayed contact hypersensitivity in guinea pigs (Buehler test, NOTOX, 2000a). The test for delayed contact hypersensitivity was performed on 30 female Himalayan guinea pigs. For the dermal inductions the initially test item concentration was 100% (v/v). A 50% (v/v) preparation of the test substance was selected for the challenge application. Topical application of the appropriate test substance concentration (20 test animals) or vehicle (10 control animals) was performed once a week for 6 hours at the flanks of each animal for three consecutive weeks. Seven days following the last induction treatment all animals were challenged with the test substance at a concentration of 50% (v/v) for 6 hours. Skin reactions of all animals were evaluated 24 and 48 hours after challenge administration. No skin reactions were noted after challenge administration. Periodic reliability checks with the positive control gave the expected results. Thus, ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) was not skin sensitising under the conditions of this Buehler test.


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

The available data on skin sensitisation of the registered substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008 and are therefore conclusive but not sufficient for classification.