Registration Dossier

Administrative data

Description of key information

Skin sensitisation (OECD 406, Buehler): not sensitizing

Read-across from structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6).

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:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Source, key, 68439-49-6, 1995a
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Source, key, 68439-49-6, 1995a
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, key, 68439-49-6, 1995a
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, key, 68439-49-6, 1995a
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Source, key, 68439-49-6, 1995a
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Source, key, 68439-49-6, 1995a
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Based on the results of a Buehler test conducted with a structurally analogue substance, the target substance is not expected to be a skin sensitiser.
Executive summary:

The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6). In the study following the Buehler test design, no skin sensitisation was observed following occlusive epicutaneous challenge after induction treatments (occlusive epicutaneous exposure). Therefore, based on read-across, for the target substance no hazard regarding skin sensitisation is expected.. As explained in the category justification, the differences in molecular structure between the target and the source substances 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 regarding skin sensitisation are available for C16AE (CAS 9004-95-9). Therefore, the skin sensitizing potential was addressed using reliable data as available from the structurally-related substance C16-18AE (CAS 68439-49-6) for read-across. The study (Sasol, 1995a) was conducted according to OECD Guideline 406 (Buehler Test). In this study 20 female guinea pigs were induced by an epicutaneous occlusive dressing with 100% test substance (in maize oil) for 6 h on Day 0, 7 and 14. Two weeks after the last induction animals were challenged by epicutaneous occlusive exposure for 6 h to 100% test substance (in maize oil). 24 and 48 h after patch removal the application site was assessed for signs of local irritation. No dermal reactions indicating skin sensitisation were observed in any test animal at any time point.

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

According to the classification criteria of Regulation (EC) No. 1272/2008 (CLP), the substance does not need to be classified for skin sensitisation. No data is available for respiratory sensitisation.