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EC number: 290-754-9
CAS number: 90218-76-1
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.
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)
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