Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
165 mg/kg bw/day
Additional information

This UVCB substance isclassified as a reproductive hazard (GHS category 1B; DSD R60, category 2) based on the presence of the impurity, tetrapropenyl phenol (a.k.a. Dodecylphenol, EC Number 310-154-3). Tetrapropenyl phenol effected fertility in 1 and 2-generation reproductive toxicity studies but did not adversely impact development.

A specific concentration limit (SCL) for materials containing TPP as an impurity has been established(2). The SCL is based on a NOAEL of 15 mg/kg/day TPP in an OECD 416 two generation reproductive toxicity study in rats. Levels of TPP below this NOAEL are not expected to cause reproductive toxicity in an animal model. Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc contains 9.1% TPP as an impurity. As such, a dose of 165 mg/kg/day (15 mg/kg/day divided by 0.091) of this UVCB substance is not expected to cause any reproductive effects in a multi-generation animal study.  

The 165 mg/kg/day NOAEL is also used to calculate the DNEL of this substance for reproductive toxicity. The calculation of the DNEL uses assessment factors specific for TPP as the goal is to determine a level of TPP that will not cause adverse effects.

The zinc dialkyldithiophosphate present inphenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc is not expected to cause reproductive or developmental toxicity based on read across to zinc bis[O, O-bis(2-ethylhexyl) ] bis(dithiophosphate) (CAS RN 4259-15-8, EINECS: 224-235-5).

Justification for classification or non-classification

This substance is classified under GHS as a category 1B reproductive hazard and under the DSD as an R60, category 2 based on the presence of the impurity tetrapropenyl phenol (EC No. 310-154-3)