Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
Written assessment
Type of information:
other: Written assessment
Adequacy of study:
other information
Study period:
January 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
Report Date:
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Test Item Name: NAUGARD® XL-1
Laboratory Master Schedule No. at FumoPrep Ltd.: 4174
Manufacturer: Addivant USA LLC
Chemical Name: (1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tertbutyl-4-hydroxyphenyl)propionate]
Batch/Lot Number: 11608030
CAS Number: 70331-94-1
Appearance: White powder
Manufacture Date: 30 August 2016
Expiry Date: 29 August 2020
Purity: 99.4%
Storage: Condition Controlled room temperature (15-25 °C) protected from light
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

Bioaccessibility testing results:
See attached background material below.

Applicant's summary and conclusion

Conclusions:
In conclusion, there is evidence that the substance, could be readily absorbed on ingestion and metabolised quickly to amino acids, amines and ultimately oxidised to carbon dioxide and nitrogen compounds, with no ill effects noted.
Consequently, the substance is considered to have low bioaccumulation potential.
Executive summary:

In conclusion, there is evidence that the substance, could be readily absorbed on ingestion and metabolised quickly to amino acids, amines and ultimately oxidised to carbon dioxide and nitrogen compounds, with no ill effects noted.

Consequently, the substance is considered to have low bioaccumulation potential.