Registration Dossier
Registration Dossier
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EC number: 274-572-7 | CAS number: 70331-94-1
Basic toxicokinetics
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:
- 2 018
- 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 substance name:
- (1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- EC Number:
- 274-572-7
- EC Name:
- (1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Cas Number:
- 70331-94-1
- Molecular formula:
- C40H60N2O8
- IUPAC Name:
- (1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- 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.
Constituent 1
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 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.
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