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EC number: 254-588-0
CAS number: 39670-09-2
Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test including neurotoxicity assessment oral (gavage); rat (Hsd: Sprague Dawley SD, m/f (OECD guideline 422, GLP): NOAEL(neurotoxicity) = 1000 mg/kg bw/d
indication of neurotoxicity
was found in a Combined Repeated Dose Toxicity Study with the
Reproduction / Developmental Toxicity Screening Test according to OECD
Guideline 422 (22 March 1996) which included a Functional Observation
Battery, examination of grip strength and sensory reactivity to stimuli
as well as motor activity assessment:
was administered to 10 Hsd: Sprague Dawley SD rats/sex/dose orally by
gavage at dose levels of 0 (control), 100, 300 and 1000 mg/kg bw/d. The
treatment schedule included 2 weeks before pairing, during pairing, post
coitum and post partum periods up to day 3 post partum.
Animals were administered for approximately 5 and 8 weeks for males and
of animals at removal from the cage and in an open arena (neurotoxicity
assessment) did not reveal changes attributable to the test item. No
relevant differences were noted in motor activity and sensory reaction
to stimuli between control and treated groups.
the basis of the results obtained in the study, the NOAEL for
neurotoxicity was 1000 mg/kg bw/d (males/females).
human data are available for neurotoxicity. However, there is no reason
to believe that these results from rat would not be applicable to humans.
the available data ET3EGMA does not need to be classified for
neurotoxicity according to Directive 67/548/EEC as well as CLP, EU GHS
(Regulation 1272/2008/EC) and therefore labelling is not necessary.
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