Registration Dossier
Registration Dossier
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EC number: 270-471-7 | CAS number: 68441-67-8
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Written assessment
- Type of information:
- other: Written assessment
- Adequacy of study:
- other information
- Study period:
- 21 May 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 company data
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Objective of study:
- other: Written assessment of ADME
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Written assessment based on available study data.
- GLP compliance:
- no
Test material
- Reference substance name:
- Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol
- EC Number:
- 270-471-7
- EC Name:
- Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol
- Cas Number:
- 68441-67-8
- Molecular formula:
- Not applicable - UVCB
- IUPAC Name:
- Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol
- Test material form:
- liquid
- Details on test material:
- Designation in Test Facility: 16102602G
Date of Receipt: 26. Oct. 2016
Condition at Receipt: Room temperature, in proper conditions
Specification
Name Hatcol 3178
Batch no. 2011280182
Appearance: Clear liquid
CAS No.: 68441-67-8
EINECS-No.: 270-471-7
Molecular formula: C33H60O8 to C41H76O8 (in CH2 unit increments)
Molecular weight: 692 daltons
Purity: 99.6 %
Homogeneity: homogeneous liquid
Stability: H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility: H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Production date: 18. Jul. 2011
Expiry date: 01. Nov. 2019
Storage: Room Temperature (20 ± 5°C)
Storage in Test Facility
The test item was stored in a closed flask at 15.8 – 22.0 °C, protected from humidity.
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:
- Oral, dermal and inhalation absorption of decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol appears to be low. This is based on the lack of significant toxicological relevance effects noted in the acute/repeated dose oral and dermal studies with the substance and the respective read across substances.
Following ingestion, it is likely that these substances undergo lipase-catalysed hydrolysis in the gastrointestinal tract, releasing fatty acids and pentaerythritol. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells.
Pentaerythritol is metabolised in the liver and plasma then excreted in the urine unchanged or in conjugated form.
Consequently, the substance is considered to have low bioaccumulation potential. - Executive summary:
Oral, dermal and inhalation absorption of decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol appears to be low. This is based on the lack of significant toxicological relevance effects noted in the acute/repeated dose oral and dermal studies with the substance and the respective read across substances.
Following ingestion, it is likely that these substances undergo lipase-catalysed hydrolysis in the gastrointestinal tract, releasing fatty acids and pentaerythritol. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells.
Pentaerythritol is metabolised in the liver and plasma then excreted in the urine unchanged or in conjugated form.
Consequently, the substance is considered to have low bioaccumulation potential.
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