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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 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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