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EC number: 203-652-6
CAS number: 109-16-0
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:
(95.8% a.i.) 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 females, respectively.
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.
Justification for selection of effect on neurotoxicity via oral
OECD guideline 422 study including neurotoxicity assessment, no
the available data TREGDMA 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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