Registration Dossier

Administrative data

Description of key information

No repeat dose study is available for EC 259-048-8. However, sufficient data and information are available to conclude on the potential hazard as well as establish a protective point-of-departure for the risk assessment to ensure safe use. A weight of evidence is provided that demonstrates:

 

1.      No repeat dose/target organ toxicity is expected based on:

a.      Data for analog substances

b.      Low bioavailability based on TK information

c.      Low biological reactivity predicted by OECD QSAR toolbox

 

2.      EC 259-048-8 contains an impurity, phenol, dodecyl-, branched (AKA TPP; CAS 121158-58-5), which is a reproductive hazard category 1B. The risk assessment is conducted based on the residual amount of TPP in EC 259-048-8. As a result: 

a.      The DNEL is based on the extensive toxicity data available for TPP. This is sufficiently protective as demonstrated by comparing the DNELs to an analog zinc dialkyldithiophosphate ester (ZDDP) that has greater bioavailability based on smaller molecular size

b.      Appropriate Risk Management Measures are already in place consistent with a reproductive hazard

 

Therefore, additional animal studies are not necessary.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

No target ogran toxicity is expected based on a combination of no target organ toxicity with analogs containing the same functional group; low bioavailabiltiy based on physiochemical properties; and low reactivity predicted based on QSAR predictions. Therefore, no classification is warranted.