Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Eight studies with repeated oral administration of sodium barbital exist: seven studies with sufficient reliability and one not reliable study. No study with inhalative or dermal exposure is available.

Effects of sodium barbital on male rats and mice were examined in 12 -day to 64-week studies. Increases in liver-to-body weight ratios and increased levels of cell proliferation/ elevated levels of DNA synthesis in renal tubular cells were observed . Sodium barbital had no effect on hepatic metallothionein concentrations in male mice. Livers of male mice fed sodium barbital showed centrilobular hepatocytomegaly. Due to missing information on histologic or clinical pathology alterations indicative of liver toxicity, it cannot be finally clarified whether hepatocytomegaly in this case was an adaptive/non-adverse reaction or an adverse reaction. Impairment of functional capacity or impairment of capacity to compensate for additional stress or increase in susceptibility to other environmental influences was not described. Females were either not examined or did not show such effects.

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification