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EC number: 914-459-8
CAS number: -
The results of the reproductive/developmental screening test are
presented in chapter 7.8.1
The effects after repeated dosing with Licowax S FL, as well as any
effects of the test item on male and female reproductive performance,
such as gonadal function, conception, parturition and early lactation of
the offspring were investigated in a study according to guideline OECD
422, with extended treatment prior to mating. Groups of 10 male and 10
female Sprague-Dawley rats received Licowax S FL by gavage at dosages of
10, 100 and 1000 mg/kg/day. A similarly constituted group of animals
received the vehicle (sesame oil) and acted as a control. All doses were
administered at a constant volume of 10 ml/kg body weight. Males were
treated for 10 weeks prior to pairing and during pairing until the day
before necropsy, for a total of approximately 15 weeks. Females were
treated for 10 weeks prior to pairing, during pairing and throughout the
gestation and lactation periods until Day 3 post partum.
Body weight, body weight gain, clinical signs (including neurotoxicity
assessment, motor activity and sensory reaction to stimuli), food
consumption, mating performance, ophthalmoscopy and bleeding time
measurements were evaluated.Clinical pathology investigations
(haematology and clinical chemistry) were also evaluated. At necropsy a
detailed external and internal examination was performed. The
histopathological examination, including identification of the stages of
the spermatogenic cycle was carried out in five males of control and
high dose groups, selected randomly. No relevant signs of toxicological
significance were observed in any of the above parameters investigated
during the in-life phase or at post mortem examination. There were no
significant differences between treated and control groups. In an
additional investigation, no differences in bleeding time were noted
between control and high dose groups during
week 4 of the study.
On the basis of these results the NOAEL (No Observed Adverse Effect
Level) for males and females could be considered 1000 mg/kg/day.
Therefore, the test substance has not to be classified for repeated oral
toxicity according to Regulation (EC) 1272/2008 and Council Directive
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