Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

1,2,4 -Benzenetricarboxylic acid, decyl octyl ester was tested in rats to detect the effects on pregnant animals, when the material was administered during the period of organogenesis. The study design was based on OECD Guideline of Testing of Chemicals No. 414 "Prenatal" Developmental Toxicity Study", adopted 22nd January 2001.

Mated female Sprague Dawley rats were randomised into 3 test groups and a control group, each containing 24 animals. The animals were dosed by oral gavage over Days 6 -19 of gestation. Dose levels administered were 0, 100, 300 and 1000 mg/kg/day.

Animals were regularly monitored during gestation for clinical signs of toxicity and for effects on body weight and food consumption performance. They were killed on Day 20 of gestation. The status of each implantation was recorded and the foetuses were weighed and examined for visceral and skeletal abnormalities, including the state of skeletal ossification.

On the basis of the results obtained in this study, the dosage of 300 mg/kg/day could be considered the NOAEL for maternal toxicity and the dosage of 1000 mg/kg/day the NOAEL for embryo-foetal effects. No exposure related developmental toxic effects were observed in the study.

In the subchronic oral rat study there were not seen any indications for reproductive effects, investigated were spermatogenic staging, oestrus cycle, weights of ovaries and testes, including microscopic and macroscopic observations. The NOAEL for these kind of effects were therefore 1000 mg/kg bw/d.

Justification for classification or non-classification

The results of the developmental study and reprotoxicity investigations show that 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters does not does not warrant classification according to Regulation (EC) No 1272/2008.