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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Description of key information

Denatonium benzoate is an animal repellent that is primarily used to control wild and domestic animals from feeding on trees, shrubs and other non-food woody plants. Denatonium benzoate was of moderate acute toxicity to laboratory animals exposed via the oral route, but is extremely bitter and unlikely to be ingested in any appreciable amount by humans. It was of low acute toxicity to animals exposed by either the inhalation or dermal route. Denatonium benzoate was not irritating to the eyes or skin and is not considered to be a skin sensitizer.

Post application Non-Occupational Exposure and Risk Assessment

Non-occupational post-application exposure may occur from the use of denatonium benzoate in residential settings; however, exposure is expected to be minimal given the use scenario, timing of application and low likelihood of contact with sprayed areas. Current label instructions restrict entry into treated sites until spray has dried.

Incidental oral exposure (for example, hand-to-mouth exposure) from treated plants and outdoor household items is expected to be very minimal as denatonium benzoate is a bittering agent used to make harmful household chemicals less palatable for children.

The available database was sufficient to conclude that there is a very low level of concern for the hazard following exposure to denatonium benzoate and hence toxicokinetic study was considered for waiver in the absence of any data related to toxicokinetics of Denatonium Benzoate.

Since Denatonium benzoate is extremely bitter and unlikely to be ingested in any appreciable amount by humans. It was of low acute toxicity to animals exposed by either the inhalation or dermal route. Thus, the chemical is expected to have low bioaccumulation potential, if ingested.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

Denatonium benzoate is extremely bitter and unlikely to be ingested in any appreciable amount by humans. It was of low acute toxicity to animals exposed by either the inhalation or dermal route. Thus, the chemical is expected to have low bioaccumulation potential, if ingested.