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EC number: 204-411-8
CAS number: 120-61-6
The reproductive toxicity of DMT has been investigated in an older
one-generation study in the rat (Krasavage et al, 1972;1973).
Dimethyl terephthalate was administered to groups of 20 male rats in the
diet for 115 days, at doses of 0, 0.25, 0.5 and 1.0%.
The male rats were then mated with twenty virgin females which had also
been fed the dimethterephthalate diet for 6 days prior to mating. Male
rats treated with dimethyl terephthalate showed normal mating behaviour.
All treatment groups had a higher percentage of inseminations than the
control group. Ninety-five to 100% of these inseminations resulted in a
pregnancy with a normal gestation period and litter size. The only
effect seen in pups was a statistically significant reduction in body
weight at weaning compared to the control in the 0.5 and 1.0% dose
groups. The NOAEL for reproductive toxicity can be considered to be 1%
dimethyl terephthalate in the diet, the NOAEL for parental toxicity was
0.5% and the NOAEL for offspring toxicity was 0.25%.
Using the default conversion factors, dose levels are calculated to be
approximately equivalent to 250, 500 and 1000 mg/kg bw/d.
A waiver is proposed for further testing for reproductive toxicity.
Existing data for the substance, including developmental toxicity
studies in rodent and non-rodent species, a one-generation reproduction
toxicity study and 90-day studies using oral and inhalation exposure do
not indicate any effects on the reproductive organs or on fertility or
reproductive performance. Additional tetsing in a two-generation study
is not justified for scientific reasons or on animal welfare grounds.
Short description of key information:
No evidence of an effect on fertility or reproductive capacity was
seen in a one-generation study in the rat at dose levels up to and
including approximately 1000 mg/kg bw/d. Findings in offspring were
limited to bodyweight effects at weaning, likely to be attibutable to
reduced dietary palatability.
No evidence of developmental toxicity was seen in a guideline-compliant rat study at the limit dose of 1000 mg/kg bw/d.
Dimethyl terephthalate was administered to female Wistar rats via
gavage, at a dose of 1000 mg/kg bw/d, on days 7 through 16
post-copulation (Hoechst, 1986). Controls received the vehicle alone.
Dams were sacrificed on gestation day 21 for examination of uterine
contents. There was no evidence of maternal toxicity. No embryotoxic or
teratogenic effects were observed. The NOAEL for maternal and
developmental toxicity in rats is therefore the limit dose of 1000 mg/kg
An OECD 414 prenatal developmental toxicology study also was performed
using DMT in rabbits.
There were no adverse effects on maternal survival, clinical or
macroscopic findings, body weights, food consumption, clinical pathology
parameters, and organ weights at 200, 400, and 600 mg/kg/day when
dimethyl terephthalate (DMT) was offered in the diet (pellets) to New
Zealand White rabbits. In addition, there were no test substance-related
effects on intrauterine growth and survival and fetal morphology at any
dosage level. Based on these results, a dosage level of 600 mg/kg/day
(test substance concentration of 479 mg/kg/day), the highest dosage
level evaluated, was considered to be the no-observed-adverse-effect
level (NOAEL) for maternal and embryo/fetal developmental toxicity when
DMT was offered in the diet (pellets) to New Zealand White rabbits.
Dimethyl terephthalate had no effects on rat reproduction, and did not
result in embryotoxic or teratogenic effects, and therefore does not
warrant classification according to Regulation (EC) No. 1272/2008 (CLP).
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