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EC number: 275-073-7 | CAS number: 70969-70-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Conducted on Humans
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2005-06-06 to 2005-07-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated insult patch test on humans, protocol No. 1.01
- Principles of method if other than guideline:
- This study has been performed with adherence to the applicable ICH guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR part 50 and 56 and in accordance with standard operating procedures and applicable protocols.
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- The study was conducted on human subjects, as per annex VII 8.3.1 Column 2: an LLNA test does not need to be conducted because In vivo skin sensitisation studies were carried out or initiated before 11 October 2016, and they meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4).
Test material
- Reference substance name:
- 2-ethylhexyl 3,5,5-trimethylhexanoate
- EC Number:
- 275-073-7
- EC Name:
- 2-ethylhexyl 3,5,5-trimethylhexanoate
- Cas Number:
- 70969-70-9
- Molecular formula:
- C17H34O2
- IUPAC Name:
- 2-ethylhexyl 3,5,5-trimethylhexanoate
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Fifty-nine qualifed subjects (15 male and 44 female) ranging in age from 16 to 79 years, were selected for this evaluation. Fifty-two subjects completed this study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material. No controls (postive or challenge) were used.
Only one dose (undiluted) was applied.
The treatment area was defined as the epicutaneous area of the upperback between the scapulae. Approximately 0.2 mL of the test material, or an amount sufficient to cover the contact surface was applied to the 1" x 1" absorbent pad portion of a clear adhesive dressing. This was then applied to the appropropriate treatment site to form a semi-occlusive patch.
Results and discussion
- Positive control results:
- No controls used
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 52
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 52.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 52
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 52.0. Clinical observations: none.
Any other information on results incl. tables
The following Evaluation Key was used during induction and challenge phase:
0 = No visible skin reaction
+ = Barely perceptible or spotty erythema
1 = Mild erythema covering most of the test site
2 = Moderate erythema, possible presence of mild edema
3 = Marked erythema, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration
During induction phase only one subject showed a moderate erythema, which fully reversed till the second induction. one other subject showed a mild erythema at the first induction reading which revered till the next reading. Thus the substance also did not show any significant skin irritation.
During first and second challenge, no positive reactions were obversed in any of the volunteers (all scores 0).
The study authors concluded that under the conditions of this study, test material Body Oil RP113 -44, did not indicate a potential for dermal iriitation or allergic contact sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 2-ethylhexyl 3,5,5-trimethylhexanoate is not sensitising to skin as shown on 52 human volunteers.
- Executive summary:
59 volunteers (of which 52 concluded the test) were exposed semi-occlusive to undiluted test material in total 10 times in the induction phase. No significant skin irritation was obeserved throughout this induction phase. Two weeks following the induction phase, volunteers were exposed semi-occlusively again to the undiluted test material (challenge phase) and none of them did show any positive reaction. The study authors concluded that under the conditions of this study, test material Body Oil RP113 -44, did not indicate a potential for dermal iriitation or allergic contact sensitization.
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