Registration Dossier

Administrative data

Description of key information

skin sensitisation, rabbit (OECD 406, Buehler): not sensitising

Read-across from structural analogue source substance propane-1,2,3-triyl triheptanoate (CAS 620-67-7).

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 analogue justification provided in IUCLID section 13
Reason / purpose:
read-across source
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: CAS 620-67-7
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: CAS 620-67-7
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: CAS 620-67-7
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: CAS 620-67-7
Group:
positive control
Remarks on result:
other: data on positive control not available
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Executive summary:

The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study of a structural analogue source substance. In a Buehler test, guinea pigs were first epicutaneously induced and afterwards epicutaneously challenged with the source substance with an occlusive dressing. No skin sensitisation was observed at any time during the study. Therefore, also for the target substance no skin sensitisation potential is identified. As explained in the analogue 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:

Skin sensitisation

There are no data available on the skin sensitising potential of propane-1,2,3-triyl 2-ethylhexanoate. In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006 read-across from the structurally related analogue substances propane-1,2,3-triyl trisheptanoate (CAS 620-67-7) is conducted.

Propane-1,2,3-triyl trisheptanoate was tested for its skin sensitising potential in a study performed according to GLP and OECD guideline 406 following the Buehler test procedure (Hüls, 1993c). 20 Dunkin Hartley/Pirbright White guinea pigs were epicutaneously induced with the undiluted substance three times for 6 h under occlusion, each seven days apart. Two weeks after the last induction, the challenge was conducted with 100% substance applied to the skin for 6 h under occlusive conditions. No test substance-related systemic effects and change in body weight development were observed in the test or control animals and no skin reactions were noted 24 and 48 h after the challenge, indicating that propane-1,2,3-triyl trisheptanoate is not sensitising to skin.

Conclusion

In conclusion, the available data on the skin sensitising potential of the structural analogue propane-1,2,3-triyl trisheptanoate indicate that propane-1,2,3-triyl 2-ethylhexanoate is not sensitising to the skin.

 

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within the CSR.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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