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EC number: 281-092-1
CAS number: 83863-30-3
Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cananga odorata, Annonaceae.
Test article intake
* Mean of means of all periods, weighed for number of measurement
intervals per period:
Males: ((4 x mean premating) + (4x mean mating)) / 8
Females: ((15 x mean premating) + (20 x mean post-coitum) + (14 x mean
lactation)) / 49
The repeated dose toxicity 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 10
rats per dose per sex. 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 toxicology: mortality and moribundity, clinical signs,
functional observations and locomotor activity, body weight and food
consumption, estrous cycle determination, clinical pathology,
measurement of thyroid hormone T4 (F0-males), gross necropsy findings,
organ weights and histopathologic examinations.
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. The treatment related decrease of body
weight gain at 15000 ppm for both males (-6%) and females (-10%) were
considered non adverse. For females the reduced food consumption at
15000 ppm was considered non adverse. Non-adverse test item related
morphological alterations were present in the thymus of females treated
at 15000 ppm and consisted of minimal lymphoid depletion. 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 is a rat specific protein and is not
considered relevant to humans risk assessment.
Under the conditions of this study, the NOAEL for repeated dose toxicity
was established to be 7500 ppm in males and females, corresponding to
718 mg/kg bw/day and 953 mg/kg bw/day respectively. Based on this
result, Ylang Ylang I does not need to be classified for specific target
organ toxicity following repeated exposure in accordance with the
criteria and guidance values outlined in Annex I of the CLP Regulation
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