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Diss Factsheets
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EC number: 940-730-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- skin hydration and barrier integrity volunteer study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 June 2020 to 9 October 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
- Type of study / information:
- Double blind, randomised investigation of the hydrating efficacy and the skin barrier integrity efficacy of hydrocarbon substances in human volunteers.
- Endpoint addressed:
- skin irritation / corrosion
- other: skin hydration and skin barrier efficacy
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A double-blind, randomised trial in volunteers.
Skin hydration was assessed by measurement of skin capacitance compared with a placebo, a negative control and a positive (hydrating) control. Measurement of skin capacitance is a standard method for the assessment of skin hydration (Qassem, 2019).
Skin barrier integrity efficacy was assessed by measurement of the skin transepidermal water loss (TEWL) compared with a placebo and a negative control. Measurement of TEWL is a standard method for the assessment of skin barrier function, increase in TEWL indicates skin irritation (Kovács et al., 2020). A decrease in TEWL indicates enhancement of the barrier function of the skin (Kottner et al., 2015). - GLP compliance:
- no
Test material
- Reference substance name:
- Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics
- EC Number:
- 940-730-5
- Cas Number:
- 1437281-01-0
- Molecular formula:
- None available - not a single isomer - see remarks
- IUPAC Name:
- Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics
Constituent 1
Method
- Ethical approval:
- confirmed, but no further information available
- Remarks:
- The Clinical Investigation Plan was approved by the Ethics Committee for Health of Inovapotek. Subsequent revisions to the procedure included making alterations recommended by the Ethics Committee.
- Details on study design:
- Healthy adult volunteers not suffering from skin disease were split into four groups. Test areas, eight per subject, four per forearm, were outlined using plastic marker. Each group had a different set of test substances. Ten test substances were tested at two different concentrations, 5% and 100%. Each subject received a single application of five test substances, with a placebo, a negative control (water), and a positive control (for skin capacitance measurement)
Volume applied: 2 µl/cm²
Placebo: Span 80 (0.65%) and Tween 80 (0.20%) in water
Negative control: water
Positive control for the skin capacitance measurements: aqueous solution of glycerine at 85%, Justification for choice of positive control: not given in report, however, glycerine is a known moisturiser and not classified for skin defatting from repeated skin contact (Lodén, 2002; Milani, 2017).
Measurement of skin capacitance
- Frequency of measurement of skin capacitance: before application, then at 2, 4, 8 and 24 hours
- Replication: measurements made in triplicate
- Equipment for measurement of skin capacitance: Corneometer®
Measurement of skin transepidermal water loss (TEWL)
- Frequency of measurement of TEWL: before application, then at 2, 4, 8 and 24 hours
- Replication: measurements made in triplicate
- Equipment for measurement of TEWL: Tewameter®
Statistical analysis: Wilcoxon test; Student’s T-test. Extreme outliers were identified by statistical analysis and removed from the analysis of differences and mean values. - Details on exposure:
- single application Volume applied: 2 µl/cm²
Measurements: 0, 2, 4, 8 and 24 hours
Results and discussion
- Results:
- In a study involving human volunteers, a single cutaneous application of Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics (Shell GTL Solvent GS270) resulted in a statistically significant increase in skin hydration relative to the placebo up to 2 hours after application at a concentration of 100%, at 5% skin hydration was unaffected. The TEWL was unchanged relative to the placebo after application at concentrations of 5% and 100%.
These results indicate that, after a single application Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics is effective as a skin moisturiser. Based on these results, it is concluded that the test substance does not require classification for skin defatting from repeated skin contact.
Any other information on results incl. tables
See Tables of results attached to this summary.
Applicant's summary and conclusion
- Conclusions:
- In a study involving human volunteers, a single cutaneous application of Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics (Shell GTL Solvent GS270) resulted in a statistically significant increase in skin hydration relative to the placebo up to 2 hours after application at a concentration of 100%, at 5% skin hydration was unaffected. The TEWL was unchanged after application at concentrations of 5% and 100%.
These results indicate that, after a single application Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics is effective as a skin moisturiser and does not affect the skin barrier as measured by the transepidermal water loss. Based on these results, it is concluded that the test substance does not require classification for skin defatting from repeated skin contact. - Executive summary:
Repeated dermal contact with petroleum-derived hydrocarbons causes skin dryness and cracking, and Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics was formerly classified for skin defatting from repeated skin contact: EUH066, based on precaution. To establish whether this classification was justified, a study has been conducted with volunteers to investigate the hydrating efficacy and the skin barrier integrity efficacy of a number of substances in a double-blind, randomised study. The test substances included Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics.
Skin hydration was assessed by measurement of skin capacitance compared with a placebo (Span 80 (0.65%) and Tween 80 (0.20%) in water), a negative control (water), and a positive control. The positive control was an aqueous solution of glycerine at 85%, glycerine is a known moisturiser and not classified for skin defatting from repeated skin contact.
Skin barrier integrity efficacy was assessed by measurement of the skin transepidermal water loss (TEWL) compared with a placebo (Span 80 (0.65%) and Tween 80 (0.20%) in water) and a negative control (water).
Healthy adult volunteers were split into four groups. Each subject received a single application of 2 µl/cm² of five test substances, a placebo, a negative control and, for the skin capacitance measurement, a positive control. Test and control substances were applied to eight separate sites, four on each forearm, of each volunteer in the group. Each group had a different set of test substances.
Ten test substances were tested at two different concentrations, 5% and 100%. The test substances, referred to in the report by product name only, were:
- Hydrocarbons, C9-C11, n-alkanes isoalkanes, <2% aromatics (Shell GTL Solvent GS190)
- Hydrocarbons, C11-C16, n-alkanes isoalkanes, <2% aromatics (Shell GTL Solvent GS1927)
- Hydrocarbons, C10-C13, n-alkanes isoalkanes, <2% aromatics (Shell GTL Solvent GS215)
- Hydrocarbons, C14-C16, n-alkanes isoalkanes, <2% aromatics (Shell GTL Solvent GS250)
- Hydrocarbons, C15-C19, n-alkanes isoalkanes, <2% aromatics (Shell GTL Solvent GS270)
- Hydrocarbons, C18-C24, isoalkanes, <2% aromatics (Shell GTL Solvent GS310)
- Shell GTL Normal Paraffin 10-13
- Shell Risella X 415 (GTL Base Oil Distillates)
- Saraline 185V (GTL Gasoil)
- Distillates (petroleum), hydrotreated light (C13-C15 alkanes and naphthenics) (EC No. 265-149-8; ShellSol D100)
The skin hydration measurements were performed at each test site, in triplicate, before application of the test and control substances, and at 2 hours, 4 hours, 8 hours and 24 hours after application.
The skin transepidermal water loss (TEWL) measurements were performed at the same test sites and time intervals as the skin hydration measurements.
Application of Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics (Shell GTL Solvent GS270) resulted in a statistically significant increase in the skin hydration relative to the placebo up to 2 hours after application at a concentration of 100% , at 5% skin hydration was unaffected.
Application of Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics (Shell GTL Solvent GS270) did not affect the TEWL relative to the placebo at concentrations of 5% and 100%, indicating no effect on the skin barrier condition.
These results indicate that, after a single application, Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics is effective as a skin moisturiser and does not affect the skin barrier. Based on these results, it is concluded that the test substance does not require classification for skin defatting from repeated skin contact.
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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