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EC number: 246-562-2
CAS number: 25013-15-4
Toxicity to Reproduction (Screening): In accordance with Column 2 of ANNEX VIII of the REACH regulation, screening for reproductive/developmental toxicity study does not need to be conducted as a pre-natal developmental toxicity study is available.
Extended one-generation reproductive toxicity: In accordance with Column 2 of ANNEX IX of the REACH regulation, a extended one-generation reproductive toxicity study does not need not to be conducted as the existing repeated dose toxicity study does not indicate adverse effects on reproductive organs or tissues.
Pre-natal developmental toxicity study (rat, oral):NOAEL for maternal/foetotoxicity toxicity: 600 mg/kg bw/day.NOAEL for embryotoxicity/teratogenicity: 600 mg/kg bw/day.
A study was conducted to determine the teratogenic potential of the read across substance, 4-methylstyrene. Groups of 25 pregnant Charles River COBS CD rats were given the test substance by oral gavage (volume, 5.0 ml/kg), from Gestation Day (GD) 6 to 19 at a single daily dose of 50, 300, and 600 mg/kg/day. A control group received the vehicle only, olive oil, at a dose volume of 5 mL/kg bw.
There were no mortalities or clinical signs in the maternal groups. Compared to controls, there was a reduction in maternal weight gain in all treated groups and this was considered not statistically significant. Fetal weights in all treated groups were also significantly lower than the controls. However, this may have been the results of an unusually high control value for fetal weight, above the normal background range of the laboratory. There were no biologically meaningful differences in the mean number of corpora lutea, total implantations, early or late resorptions, post implantation loss, viable fetuses, fetal sex distribution, mean fetal body weight or number of fetuses (and litters) with malformations.
Under the study conditions, the NOAEL for teratogenicity was established at 600 mg/kg bw/day.
In the pre-natal developmental toxicity study( Hardin BD,1981),female Sprague-Dawley rats was daily intraperitoneally administrated with the test chemical dissolved or suspended in corn oil at 250 mg/kg for 15 days.
The incidence of resorptions was significantly increased (p<0.05), and the fetal sex ratio was significantly altered (p<0.05) with a deficit of female fetuses. No teratogenic effects were observed. In addition, no treatment-related histopathological changes were observed in maternal tissues.
The substance is non-teratogenic.
Based on the available information in the dossier, the substance Vinyltoluene does not need to be classified for reproductive toxicity when the criteria outlined in Annex I of 1272/2008/ EC are applied.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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