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EC number: 953-513-5
CAS number: -
An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for Dihydronepetalactone to produce toxicity from a single dose via the oral route.
An acute dermal toxicity test was conducted with rats to determine the potential for Dihydronepetalactone to produce toxicity from a single topical application. Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 5000 mg/kg of body weight in male and female rats.
Five thousand milligrams of the test substance per kilogram of body weight was applied to the skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed on all animals at terminal sacrifice.
All animals survived test substance administration, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation, adverse clinical effects, or abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Based on a limit dose of 5000 mg/kg, a Main Test was conducted using a default starting dose level of 175 mg/kg which was administered to one healthy female rat by oral gavage. Following the Up and Down procedure, seven additional animals were dosed at levels of 550, 1750 or 5000 mg/kg. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing or until death occurred. Body weights were recorded prior to administration (initial) and again on Days 7 and 14 (terminal) following dosing or after death. Necropsies were performed on all animals.
Under the conditions of this study, the acute oral LD50 of the test substance is estimated to be 3129 mg/kg of body weight (based on an assumed sigma of 0.5) in female rats with an approximate 95% confidence interval of 1750 mg/kg (lower) to 5000 mg/kg (upper).
Adverse effects are observed for the substance Dihydronepetalactone in both the Acute toxicity oral and dermal studies. However, the effects were classified as Category 5 under GHS and it does not meet the criteria for classification according to Regulation (EC) No 1272/2008
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