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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.
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 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 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.
Test item related changes included a dose dependent increase in liver
weights (relative to body weight was significant) in females at 15000
ppm, in the absence of morphological alterations. 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) was considered adverse at 15000 ppm. Test item related increase
in kidney weights (only relative to body weight was significant) was
observed females treated at 15000 ppm. The increased kidney weight in
the absence of morphological changes was considered non adverse. 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. No reproductive toxicity was observed up to
15000ppm. In the offspring, no developmental toxicity was observed up to
7500 ppm. Treatment related decreased 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
Under the conditions of this study, the NOAEL for reproduction was
considered to be 15000 ppm corresponding 1590 mg/kg bw/day in females.
The developmental NOAEL was considered to be 7500 ppm, corresponding to
718 mg/kg bw/day (worst-case value from F0 males). Based on these
results, Ylang Ylang I does not have to be classified for reproductive
toxicity in accordance with the criteria outlined in Annex I of the CLP
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