Registration Dossier
Registration Dossier
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EC number: 222-598-4 | CAS number: 3547-33-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Studies conducted specifically to evaluate reproductive toxicity were not available. However, two oral developmental studies and a 90-day oral repeated dose study are available. The 90-day dietary study indicated no adverse effects on male and female reproductive organs up to 2% in the diet (Powers, M.B., 1961). There were no effects on any of the cesarean parameters or maternal toxicity in rats up to 1000 mg/kg/day in a oral gavage developmental toxicity study (U.S. EPA, 1995).
Effects on developmental toxicity
Additional information
In a developmental toxicity study conducted with methods similar to OECD Guideline 414, Sprague- Dawley Crl:CD BR rats (24/group) were orally administered ethanol, 2 -(octylthio) at 0, 100, 300 or 1000 mg/kg bw/day during days 6 through 15 of gestation. There was no maternal toxicity that was considered treatment-related. Dosing had no effect on any of the cesarean parameters (e.g. mean numbers of corpora lutea, implantations, live fetuses, pre- and post-implantation losses). Therefore, for maternal toxicity, the NOEL was 1000 mg/kg bw/day. Minor treatment-related skeletal variations were limited to an increase, both in the number and percent of fetuses, as well as litters with 14th vestigial ribs at 1000 mg/kg bw/day when compared to controls. The NOEL for developmental toxicity was determined to be 300 mg/kg/day (US EPA, 1995).
In a second developmental toxicity study conducted with methods similar to OECD Guideline 414, female SPF rats (20/group) were treated with ethanol, 2 -(octylthio) via oral gavage during the 5th through 15th day of pregnancy at dose levels of 47, 187 amd 748 mg/kg bw/day. Results indicated food consumption was significantly reduced in all test groups, although no maternal or fetal parameters (e.g. index of dead and alive born fetuses, index of resorptions, average number of fetuses, sex relation, etc) were affected and no embryotoxic or teratogenic effects were observed. The NOELs for maternal and developmental toxicity was determined to be 748 mg/kg bw/day (International Bio-research Inc., 1977).
In conclusion, the weight of evidence indicates that 2 -(octylthio)ethanol is not a developmental toxicant. The lowest NOAEL for developmental toxicity is 300 mg/kg/day.
Justification for classification or non-classification
Based on the available developmental toxicity data on 2-(octylthiol)ethanol, no classification under DSD or GHS/CLP is warranted.
Additional information
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