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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Neurotoxicity

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Administrative data

Description of key information

Functional observation battery: NOAEL>4000mg/kgbw/day

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
4 000 mg/kg bw/day

Additional information

In a guideline (OECD 408) and GLP study, exposure to TGME in the drinking water of rats at doses up to 4 g/kg/day for 90 days did not result in clinical signs of toxicity, alterations in the functional observational battery, or gross or microscopic lesions in the nervous system. Minor decreases in motor activity were observed in the 4 g/kg/day treatment group at the Day 60 (males only) and Day 90 (males and females) evaluation periods. These decreases in motor activity were not considered to be neurotoxicologically significant based on the small magnitude of the changes, the parallel changes observed in body weights at these evaluation periods, and the lack of corroborative behavioral effects from the FOB evaluations or histological changes in central or peripheral nervous system tissues. Based on these findings 4 g/kg/day is a subchronic NOAEL for TGME neurotoxicity.

Justification for classification or non-classification

The substance does not meet the criteria for classification due to neurotoxic effects.