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EC number: 947-049-2 | CAS number: -
Parental test article intake
*Mean of means of all periods, weighed for number of measurement intervals per period:
Males: ((4x mean premating) + (4x mean mating)) / 8
Females: ((15 x mean premating) + (20 x mean post-coitum) + (14 x mean lactation)) / 49
The reproductive and developmental toxicity potential of Ylang Ylang I was tested under GLP in a combined repeated dose toxicity study with reproduction/developmental toxicity screening test according to OECD TG 422. The experiment was performed by oral administration of the test substance via diet with 5 rats per sex per dose. The tested dietary doses corresponded to 0, 2500, 7500 and 15000 ppm. Males were treated for 28 days (a minimum of two weeks prior to mating and during the mating period). Females that delivered offspring were treated 49-63 days, a minimum of two weeks prior to mating. Females that delivered no healthy offspring were treated for 41 -51 days. The following parameters and endpoints were evaluated in this study for repeated dose toxicity: mortality/ moribundity, clinical signs, functional observations and locomotor activity, body weight and food consumption, estrous cycle determination, clinical pathology, measurement of thyroid hormone T4, gross necropsy findings, organ weights and histopathologic examinations. The following parameters were evaluated in this study for reproduction and development: Mating index, preciodal time, number of implantation sites, fertility index, gestation index and duration, post implantation survival index, litter size, live birth index, viability index, lactation index. The pups were evaluated for clinical signs, body weights, sex ratio, anogenital distance, areola/nipple retention, clinical biochemistry (T4) and macroscopic changes.
In the parental animals, test item related changes included a dose dependent increase in liver weights (relative to body weight was significant), at all dose levels in males and in females at 15000 ppm, in the absence of morphological alterations. For females, but not males, an increase in ALP was noted which was statistically significant at 15000 ppm (3.8–fold increase) which in the presence of the increased liver weight was considered adverse. This increase in liver weights (>20% compared to control) were considered adverse in males and females at 15000 ppm. Test item related increase in kidney weights (only relative to body weight was significant) were observed in males and females treated at 15000 ppm. For females the increased kidney weight in the absence of morphological changes was considered non adverse. In males morphological alterations consisted of a combination of increased hyaline droplet accumulation, increased basophilia and granular casts in males treated at 7500 ppm and 15000 ppm. In addition, creatinine levels were statistically significantly increased for males treated with 15000 ppm. The hyaline droplet accumulation was considered to represent alpha2uglobulin, a normal protein in male rats which undergoes reabsorption in the proximal cortical tubules. This male rat specific protein and is not considered relevant to humans risk assessment. No mortality occurred throughout the study. One female was euthanized on PND 4 due to total litter loss. No relevant clinical signs or neurotoxicity were observed. In addition, no treatment related effects on reproductive toxicity were observed up to the highest dose. In the offspring, no developmental toxicity was observed up to 7500 ppm. Body weights of pups of the 15000 ppm dose group were statistically significantly reduced on PND 7 and 13 (approximately 17% lower compared to control on PND 13), which was considered adverse.
Under the conditions of this study, the NOAEL for reproduction was considered to be 15000 ppm corresponding to 1301 mg/kg bw/day in males and 1590 mg/kg bw/day in females. The developmental NOAEL was considered to be 7500 ppm, corresponding to 718 mg/kg bw/day in males and 953 mg/kg bw/day in females. Based on this result, Ylang Ylang I does not have to be classified for reproductive toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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