Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
Written assessment
Type of information:
other: Written assessment
Adequacy of study:
other information
Study period:
April 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Written assessment
Justification for type of information:
At the current level of registration, a written assessment is suitable.

Data source

Reference
Reference Type:
other: Written assessment
Title:
Unnamed
Year:
2018

Materials and methods

Objective of study:
other: Written assessment of ADME
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Written assessment based on available study data.

Test material

Constituent 1
Chemical structure
Reference substance name:
6,6'-di-tert-butyl-2,2'-thiodi-p-cresol
EC Number:
202-009-7
EC Name:
6,6'-di-tert-butyl-2,2'-thiodi-p-cresol
Cas Number:
90-66-4
Molecular formula:
C22H30O2S
IUPAC Name:
6,6'-di-tert-butyl-2,2'-thiodi-p-cresol
Test material form:
solid: particulate/powder
Details on test material:
Name: 6,6’-di-tert-butyl-2,2’-thiodi-p-cresol
Other name: LOWINOX® TBP-6
CAS number: 90-66-4
Batch/Lot Number: C036K0111
Description: White powder
Purity*: 99.8%
Expiry date: 29 March 2018
Storage condition: Controlled room temperature (15-25 ºC, below 70 RH%)
Safety precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
See attached background material below.
Details on distribution in tissues:
See attached background material below.
Details on excretion:
See attached background material below.

Metabolite characterisation studies

Details on metabolites:
See attached background material below.

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:
See attached background material below.

Applicant's summary and conclusion

Conclusions:
In conclusion, there is no evidence to suggest that the substance is significantly absorbed via any of the routes due to its physicochemical properties, this is coupled with the lack of effects shown in the in vivo studies, a 100% absorption rate is proposed as a worst case for oral, dermal and inhalation routes.
It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.
Executive summary:

In conclusion, there is no evidence to suggest that the substance is significantly absorbed via any of the routes due to its physicochemical properties, this is coupled with the lack of effects shown in the in vivo studies, a 100% absorption rate is proposed as a worst case for oral, dermal and inhalation routes.

It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.

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