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EC number: 700-263-8 | CAS number: 89686-69-1
A reproduction/developmental toxicity screening test with Ditetrahydrofurylpropane in rats by oral gavagewas performed according toOECD guideline 421 and GLP principles. In a 28-day oral toxicity study with Ditetrahydrofurylpropane (NOTOX project 484766), a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg was established, based on effects in liver and kidneys at 150 and 500 mg/kg. Based on these results, the dose levels for this reproduction/developmental toxicity screening test were selected to be 15, 50 and 150 mg/kg. After acclimatization, four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test substance at 0, 15, 50 and 150 mg/kg/day. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 41 -55 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation. The following parameters were evaluated: mortality / viability, clinical signs, body weights, food consumption, reproduction/developmental parameters, observations pups, macroscopy, organ weights, and histopathology. Chemical analyses of formulations were conducted once during the study to assess accuracy and homogeneity.Accuracy, homogeneity and stability of formulations were demonstrated by analyses. No parental, reproduction or developmental toxicity was observedup to the highest dose level tested (150 mg/kg bw/day). Based on the parameters assessed in this study, a parental, reproduction and developmental No Observed Adverse Effect Level (NOAEL) of at least 150 mg/kg bw/day was derived.
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