reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Endpoint summary

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information

It is not thought that the increase in post implantation loss is due to the slight maternal toxicity recorded. However, due to a deficiency in the food consumption data it is not possible to draw a firm conclusion based on an incomplete maternal data set.
Therefore Evernox 1135 will not be classified at this stage but an embryo-fetal study, on a second species, namely the rat, will be triggered at the next tonnage band so that a firm and definitive conclusion can be drawn regarding Evernox 1135 and whether it does, or does not, warrant classification as a Reproductive Toxicant. 

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

40 mg/kg bw/day

Additional information

At the highest dose of 80 mg/kg/day, treatment was associated with slight reductions in maternal food consumption and bodyweight gain. Necropsy revealed several cases of raised areas in the stomach containing hair, pale kidneys and enlarged gall bladder and these findings were considered likely to be related to treatment. Embryo-fetal development was adversely affected by treatment. The principal findings were significant increases in both embryonic and fetal resorptions (post implantation losses) resulting in a reduced number of live fetuses for evaluation. In addition, mean fetal weight was marginally lower than in Controls. Fetal pathology investigations revealed a slightly higher incidence of visceral abnormalities compared with Controls, but there was no clear pattern in the nature of the findings.

It is not thought that the increase in post implantation loss is due to the slight maternal toxicity recorded. However, due to a deficiency in the food consumption data it is not possible to draw a firm conclusion based on an incomplete maternal data set.

Therefore Evernox 1135 will not be classified at this stage but an embryo-fetal study, on a second species, namely the rat, will be triggered at the next tonnage band so that a firm and definitive conclusion can be drawn regarding Evernox 1135 and whether it does, or does not, warrant classification as a Reproductive Toxicant.

Justification for classification or non-classification

It is not thought that the increase in post implantation loss is due to the slight maternal toxicity recorded. However, due to a deficiency in the food consumption data it is not possible to draw a firm conclusion based on an incomplete maternal data set.

Therefore Evernox 1135 will not be classified at this stage but an embryo-fetal study, on a second species, namely the rat, will be triggered at the next tonnage band so that a firm and definitive conclusion can be drawn regarding Evernox 1135 and whether it does, or does not, warrant classification as a Reproductive Toxicant.