Registration Dossier

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

Short description of key information on bioaccumulation potential result:

The physical-chemical properties indicate that absorption of 1,1-di(tert-butylperoxy)-3,3,5-trimethylcyclohexane is unlikely.  1,1-di(tert-butylperoxy)-3,3,5-trimethylcyclohexane is a clear liquid with a molecular weight of 302.5, vapour pressure of 8.99.10-6 kPa at 20°C, and Log Kow is 7.0. It has a low  water solubility of ~0.1 mg/l. In addition, acute toxicity in mamalian studies is low. Neither is this substance irritating to skin or a skin sensitizer.  Carcinogenicity has been assessed as negative via the oral route. Some target organ toxicity has been demonstrated at very high oral doses in repeat-dose studies. The normal use and handling of this material mitigates against oral exposure. Therefore, according to the Guidance on Information Requirements and Chemical Safety Assessment Chapter R 7.12, and based on available data, significant absorption via oral or dermal exposures during normal use and handling  is extremely unlikely, certainly below any reasonable risk assessment threshold, and a toxicokinetic study would not generate useful information.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
20
Absorption rate - inhalation (%):
100

Additional information

The physical-chemical properties indicate that absorption of 1,1-di(tert-butylperoxy)-3,3,5-trimethylcyclohexane is unlikely. 1,1-di(tert-butylperoxy)-3,3,5-trimethylcyclohexane is a clear liquid with a molecular weight of 302.5, vapour pressure of 8.99.10-6 kPa at 20°C, and Log Kow is 7.0. It has a low water solubility of ~0.1 mg/l. In addition, acute toxicity in mammalian studies is low. Neither is this substance irritating to skin or a skin sensitizer. Carcinogenicity has been assessed as negative via the oral route. Some target organ toxicity has been demonstrated at very high oral doses in repeat-dose studies. The normal use and handling of this material mitigates against oral exposure. Therefore, according to the Guidance on Information Requirements and Chemical Safety Assessment Chapter R 7.12, and based on available data, significant absorption via oral or dermal exposures during normal use and handling is extremely unlikely, certainly below any reasonable risk assessment threshold, and a toxicokinetic study would not generate useful information.