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EC number: 285-480-1
CAS number: 85099-25-8
Calculation of the NOAEL for the read-across target substance,
i.e. the phosphate salt of cyclohexyldimethylamine, from the result
obtained in the OECD 422 study performed with the read-across source
In the OECD 422 study the NOAEL was derived at the level of 1500
ppm cyclohexyldimethylamine in the diet; this was the highest dose
tested due to palatability issues. This dietary concentration
corresponded to dose levels of 91 – 104 mg/kg body weight/day for males
and to 85 – 147 mg/kg body weight/day for females. This is summarised to
a NOAEL of cyclohexyldimethylamine of > 90 mg/kg body weight/day for
males and females.
This NOAEL is converted to the NOAEL of the read-across target
substance, i.e. the phosphate salt of cyclohexyldimethylamine, by
multiplication with the factor 1.786 resulting in 2680 ppm in diet and
160 mg/kg body weight/day.
In the repeated dose oral toxicity study performed with the read-across
source substance no effects were observed up to and including the
highest dose of 1500 ppm in the diet. This dose level of the r-a source
substance corresponds to a dose level of the target substance to be
registered of > 160 mg/kg body weight/day for males and females. In the
absence of any adverse effects non-classification is justified.
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