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EC number: 286-344-4
CAS number: 85209-91-2
Subacute combined repeated dose and reproduction / developmental
screening study (OECD 421): NOAEL for parental animals = 100 mg/kg/day.
Subchronic toxicity study: 13-weeks oral (Gavage) toxicity study (from
1986) with NA-11 in rats, similar to OECD Guideline 408 EU Method B.26:
NOEL = 500 mg/kg/day for both sexes based on food intake suppression.
The concentrations analysed in the
formulations of Group 2, Group 3 and Group 4 were in agreement with
target concentrations (i.e. mean accuracies between 85% and 115%). No
test substance was detected in the Group 1 formulation.
The formulations of Group 2 and Group
4 were homogeneous (i.e. coefficient of variation≤ 10%).
Formulations at the entire range were
stable when stored at room temperature under normal laboratory light
conditions for at least 6 hours.
recently performed combined repeated dose and reproduction /
developmental screening study a NOAEL for parental animals was derived
at the dose of 100 mg/kg/day. This value will be used in the CSA.
effect observed in the 13 week repeated dose toxicity study (from 1986)
with NA-11 was suppression of food intake in the high dose groups (1500
mg/kg b.w./day), mainly in males. This effect is thought to be due to
the large dosing volume of 15 ml/kg body weight. Other
observed effects were considered as secondary effects of the reduced
food intake. The NOEL was derived at the dose of 500 mg/kg/day.
Justification for selection of repeated dose toxicity via oral route
- systemic effects endpoint:
In the recently performed combined repeated dose and reproduction /
developmental screening study significant signs of toxicity were
observed leading to a parental NOAEL of 100 mg/kg/day. This NOAEL is
used in the CSA. In the subchronic study performed in 1986 only mild
effects of NA-11 were observed leading to a NOEL of 500 mg/kg/day.
Based on the NOAEL of 100
mg/kg bw/day derived from the recently performed combined repeated dose
and reproduction / developmental screening study , NA-11 does not need
to be classified regarding repeated dose toxicity according to
REGULATION (EC) 1272/2008.
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