Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

According the REACH guidance on information requirements r7c, toxicokinetics is not a toxicological endpoint and is not specifically required by REACH. Furthermore, REACH announces in Annex VIII (Section 8.8.1) that one should perform “assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information”. Information on absorption, distribution, metabolism and excretion is derived from available information. Available information: The results of the physico-chemical properties of SVS indicate that the oral route is the most likely route of exposure. The vapour pressure of SVS is low (0.000391 Pa at 20°C) which indicate that the inhalation route will not be the major route of exposure. SVS has a log P < -1 which suggest that the substance is not likely to be sufficiently lipophilic to cross the stratum corneum, therefore dermal absorption is likely to be low. These are the results of the toxicity test, which can contribute to toxicokinetic information. The results of the acute dermal toxicity test report a LD50 of > 2000 mg/kg bw and the skin irritation/corrosion test states that SVS is not an irritating substance. The oral acute toxicity test report a LD50 >15000 mg/kg bw. The oral repeated dose toxicity test exposed Wistar rats for 28 days. No effects were allocated at any of the parameters observed: e.g. mortality, body weight, biochemistry, mating period, gestation length, hematology, organ weight changes, gross pathology, histopathology. The NOAEL of SVS is greater than 2000 mg/kg bw. The hydrolysis test demonstrates that SVS was hydrolytically stable at pH 4, 7 and 9. Conclusion: Based on the available information, we can conclude that the oral route is the major route of exposure. The toxicity studies do not show any effects on e.g. organs, which cannot contribute to any information on the distribution of the substance. The hydrolysis study shows no major breakdown of SVS what may indicate that there are no major metabolites present in the environment and toxicity studies.