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EC number: 201-224-3
CAS number: 79-77-6
To assess reproductive toxicity results of a subchronic oral toxicity
study could be used as the scope of its examinations was extended to
cover also effects on reproductive organs (BASF, 2004). The compound was
administered to groups of 10 male and 10 female Wistar rats at dietary
concentrations of 0, 100, 1,000 and 10,000 ppm for 3 months. These
concentrations corresponded to dosages of about 7 and 8 mg/kg bw/day, 72
and 83 mg/kg bw/day or 720 and 801 mg/kg bw/day for males and females,
respectively. At necropsy, the reproductive organs of the males (testes,
epididymides, prostate gland) and females (ovaries, uterus) were excised
and analyzed histopathologically. Also, sperm motility, sperm morphology
and sperm head count (cauda epididymis and testis) were examined, which
showed no treatment related changes. The weights of the reproductive
organs were not influenced by the exposure, except for a significantly
increased absolute and relative weight of the testes (+ 12 % and + 18 %)
and relative weight of epididymides (+ 11 %) in the high dose males.
This could most likely be regarded as a result of the decreased mean
terminal body weight in these animals because no histological
abnormalities in the sex organs were detected and no histological
correlates were obtained for the changes in weights of the testes and
epididymides. Considering the normal biological variation of these organ
weight parameters together with the reduced terminal body weight of the
high dose animals these observations were not regarded as adverse
In addition to the described subchronic study, results of a
two-generation study could also be taken for assessment. No adverse
effects on reproduction were found, when 8-10 mg/kg bw/day of the
structural analogue mixed ionone isomers (CAS 8013-90-9) were
administered to the parental rats for 8 months (Sporn, 1963). Thereby,
the female rats were studied through 3 reproduction cycles for number of
pregnancies, weight and number of offspring, live pups, weight of pups
at birth and after 7 and 21 days, and the viability of the pups after
birth. The F1 generation (offspring) were allowed to reach maturity and
were then treated with 15 mg/kg of ionone prior to being subject to
reproductive toxicity testing. As a result, no effects on reproductive
parameters and organs were observed in this study. Because of the
structural similarities it can be assumed, that also for beta-ionone no
effects on the fertility have to be expected.
Teratogenicity:- NOAEL maternal: 100 mg/kg bw/day (OECD 414, rat)- NOAEL teratogenic: 400 mg/kg bw/day (OECD 414, rat)- NOAEL maternal: 50 mg/kg bw/day (OECD 414, rabbit)- NOAEL teratogenic: 50 mg/kg bw/day (OECD 414, rabbit)
toxicity was evaluated in a study performed according to OECD Guideline
414 (BASF AG, 2004). The test substance Beta Ionon R was administered as
a solution in olive oil to 25 "time-mated" (mated by breeder) female
Wistar rats/group by stomach tube at doses of 25, 100 and 400 mg/kg bw
on day 6 through day 19 post coitum (p.c.). On day 20 p.c., all females
were sacrificed and assessed by gross pathology including the uterus and
the placentae where corpora lutea were counted and number and
distribution of implantation sites (differentiated as resorptions, live
and dead fetuses) were determined. The fetuses were removed from the
uterus, sexed, weighed, and further investigated for any external
findings. Thereafter, nearly one half of the fetuses of each litter were
examined for soft tissue findings and the remaining fetuses for skeletal
a result, administration of 400 mg/kg bw elicitedsubstance-induced
effects on the dams including signs of maternal toxicity like reduced
body weight gain (-29%). The dosage of 100 mg/kg bw/day resulted in some
substance-related findings (i.e. temporary salivation, marginally
increased liver weights), which are not considered to be adverse, but
mirror some adaptive responses of the animals. At the low dose (25 mg/kg
bw/day) no substance-induced effects on the dams occurred. The test
substance had no influence on gestational parameters and did not induce
adverse signs of developmental toxicity or teratogenic effects at all
on these results,the no observed adverse effect level
(NOAEL) for maternal toxicity is 100 mg/kg bw/day. The
NOAEL for prenatal developmentaltoxicity
could be fixedat 400 mg/kg bw/day.
data resulting from two other studies could not be taken into account
for assessment, as they show clear deficits in the protocol or given
data (Tsutsumi, 1968; Gomes-Carneiro, 2003).
for prenatal developmental toxicity of Beta Ionon R is available on a
second species, i.e. the rabbit. In a study performed according to OECD
Guideline 414 and GLP (BASF SE, 2014) 22 female New Zealand White
rabbits/group received Beta Ionon R by
inclusion in the diet on
day 6 through day 29 post coitum (p.c.) at
target dose levels of 17, 50 and 200 mg/kg bw/day. On day 29 p.c., all
animals were sacrificed and subjected to an external, thoracic and
abdominal examination as well as a laparo hysterectomy. The uteri,
placentae and ovaries were examined, and the numbers of fetuses, early
and late resorptions, total implantations and corpora lutea were
recorded. Gravid uterine weights were recorded, and corrected body
weights (changes) were calculated. The fetuses were weighed, examined
for external and visceral malformations and developmental variations,
and sexed (by internal examination). Soft cephalic tissue examinations
were done for approximately half of the fetuses of all groups and
skeletal examinations were performed for all fetuses.
dietary treatment at 200 mg/kg bw/day, reduced food consumption
(absolute and relative to body weight) were noted during the entire
treatment period (days 6-29 p.c.), except for the period from days 10-14
p.c. during which temporally recovery towards normal values was noted.
In addition, reduced body weights, lower body weight gain and/or body
weight loss were recorded. Body weight gain between days 6 and 19 p.c.
was only 42 g at 200 mg/kg bw/day, compared to 335 g in controls.
Furthermore, several animals had reduced faeces production. Although the
latter finding was observed in all groups, including control animals,
there was a trend towards a longer period of reduced faeces production
following dietary treatment at 200 mg/kg bw/day as compared to the lower
dose levels. The treatment did not result in mortality or gross findings
at necropsy. No
maternal toxicity was observed in
the 17 and 50 mg/kg bw/day groups.
body weights were slightly lower in males and females at 200 mg/kg
bw/day, reaching statistical significance for males only. This change
was considered to be secondary to the reduced food intake and markedly
decreased body weight gain of the dams. No toxicologically relevant
effects on viability, litter size or sex ratio were noted up to 200
mg/kg bw/day. There were no fetal morphology findings (external,
visceral and skeletal) up to 200 mg/kg bw/day that were considered to be
toxicologically relevant. The incidence of unossified metacarpals and/or
metatarsals was slightly higher in the fetuses at 200 mg/kg bw/day,
reflecting the slightly lower fetal weights observed in this dose group.
on the results in this prenatal developmental toxicity study the
maternal and developmental No Observed Adverse Effect Level (NOAEL) for
Beta Ionon R was established as being 50 mg/kg bw/day.
Due to the negative data obtained for evaluating toxicity on fertility
and development, no classification is required.
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