Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the available information the following absorption values were derived (used for calculation of DNEL):

Absorption oral (rat) = Absorption oral (human) = 50%

Absorption dermal (human) = 20%

Absorption inhalation (human) = 50%

Key value for chemical safety assessment

Absorption rate - oral (%):
50
Absorption rate - dermal (%):
20
Absorption rate - inhalation (%):
50

Additional information

The dermal absorption of 14C-labelled 4,4'-thiobis(6-tert-butyl-m-cresol) (TBBC) was studied in female Sencar mice and male Fischer rats.

Dermal application resulted in about 20% absorption in mice with more than 70% of the initial body burden (IBB) remaining on the treated skin site 3 days after treatment. In rats, less than 20% of a dermal dose was absorbed. Absorption did not increase linearly as the dose increased. Oral and i.v. exposures were conducted in the Sencar mice. The disposition was similar between rats and mice after these routes of exposures, and the major route of elimination of absorbed TBBC was the feces in both species.

In another study the excretion and metabolism of *4,4'-thiobis(6 -tert-butyl-3 -cresol) upon i.v. administration to rats of 2.5, 16, and 26 months old was studied. Radioactivity was mainly excreted via the faeces (60 - 80% of the applied dose) during the first 72 hours. Along with a decrease in the older animal's ability to excrete TBBC-derived radioactivity in bile, feces, and urine, there was a decrease in the percentage of the dose eliminated in bile as glucuronide.

In addition, the reader is referred to page 5 of the attached document (Overview of De Gezondheidsraad 2005) for more details concerning the pharmacokinetics of 4,4'-thiobis(6 -tert-butyl-3 -cresol).

Based on the available information the following absorption values were derived (used for calculation of DNEL):

Absorption oral (rat) = Absorption oral (human) = 50%

Absorption dermal (human) = 20%

Absorption inhalation (human) = 50%