Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Dermal absorption
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- dermal absorption
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The QSAR software used (i.e., DermWin) is a model considered validated by the U.S. EPA for safety and risk assessment purposes.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): Methyl Polyhydroxymethyl Stearate
- Molecular formula (if other than submission substance): not specified in the report
- Molecular weight (if other than submission substance): not specified in the report
- Smiles notation (if other than submission substance): not specified in the report
- InChl (if other than submission substance): not specified in the report
- Structural formula attached as image file (if other than submission substance): not specified in the report
- Substance type: Mixture of functionalized fatty acid methyl esters (FAMEs), which may be derived from a variety of natural seed oils.
- Physical state: Waxy solid at room temperature
- Analytical purity: > 95.2 %
- Impurities (identity and concentrations): not specified in the report
- Composition of test material, percentage of components:
Methyl Palmitate: 9.68 %
Methyl Stearate: 17.8 %
Methyl Hydroxymethyl Stearate: 38.6 %
Methyl Dihydroxymethyl Stearate: 26.7 %
Methyl Trihydroxymethyl Stearate: 2.37 %
- Isomers composition: not specified in the report
- Purity test date: not specified in the report
- Lot/batch No.: (lot # 200500200-25-4)
- Expiration date of the lot/batch: not specified in the report
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified in the report
- Storage condition of test material: not specified in the report
Constituent 1
Results and discussion
Any other information on results incl. tables
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Applicant's summary and conclusion
- Conclusions:
- Dermal uptake for NOM is possible.
- Executive summary:
Dermal uptake for NOM is possible. Conversely, fatty acids and fatty acid methyl esters are used as penetration enhancers for drug delivery (Chukwumerije et al., 1989; Kogan and Garti, 2006) and thus, it is expected that the fatty acid properties of MPS would allow for dermal penetration. Consistent with the uses for drug delivery, dermal absorption of fatty acids are generally regarded as safe, and the toxicity profile of MPS following dermal testing is consistent with this as well. The dermal absorption of MPS has not been studied to date. However, the permeability of this compound through skin can be estimated with QSAR programs, such as the DermWin model from the US EPA. Using this application, the steady-state flux of a 1% solution of MPS through skin is estimated to be 0.65-240 mg/cm2 surface area of skin, for the various components. The calculated Kp, or rate of penetration via the DermWin model, is calculated to be 1.28-24.4 cm/hr.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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