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EC number: 407-000-3 | CAS number: 127519-17-9 CGL 384; TINUVIN 384
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Experimental data is only available for esters of a similar structure. This is used in combination with interpretation of the repeated dose studies to assess the potential for bioaccumulation.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
In the section for repeated dose toxicity, a data matrix with physico-chemical and toxicological properties of EC 407 -000 -3 and related esters is provided. Although the calculated n-octanol/water partition coefficient is very high, the ester functionality indicates that the substance could be metabolized easily. Indeed, the liver enlargement observed upon 28 -day oral dosing was reversible in the recovery period. Further information is obtained from experimental data on the related esters. This information is summarized in the following section.
Toxicokinetic and metabolism data using phenolic ring-U-14C-labelled test material is available for the analogue methyl ester (
CAS 84268-33-7
RCC project no. 904098, reported 1992 and Ciba-Geigy project no CB 91/02, reported 1991). The methylester is of lower molecular weight and may therefore be more easily cleaved than the ester group in the test item. However, the data shows that in principle this ester bond is susceptible to enzymatic hydrolysis. For the methyl ester, most radioactivity was excreted with the feces within the first 24 hours, whereas 4- 5 % were eliminated in the urine. Elimination was efficient and almost complete after 168 hours. In vitro studies with the analogue methylester showed that both 1 % rat serum and 1.25 % rat liver homogenate readily hydrolyzed the ester bond at neutral pH with hydrolysis half-times of 14 and 37 minutes, respectively. Slower turnover was observed with small intestine homogenate.
Mechanistic regarding peroxisome proliferation and repeated dose toxicity data is available for the mixture of mono- and di- esters with polyethylene glycol (EC 400 -830 -7). Peroxisome proliferation was demonstrated both for adult and fetal liver. Effects on liver caused by EC 400-830-7 were reversible during the four-week recovery period of the subchronic toxicity study (CIT 1988).
Peroxisome proliferation was also reported for the methyl ester and for 3-[3-tert-butyl-5-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]propionic acid itself (Ciba-Geigy 1989).
Based on the reversibility of liver effects and ester hydrolysis, the substance is not expected to have a potential for bioaccumulation.
The original toxicokinetic statement that was part of the testing requirements for ELINCS is attached.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.
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