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Diss Factsheets
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EC number: 940-683-0 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012.10.10-2012.21.11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Repeated insult patch test (human) carried out according to ICH Guideline E6 for Good Clinical Practice. Testmaterial is stated to be Bioester XP 3511 form the registrant but no further ID of the test substance included in the testing report. Registrant state that Bioester XP 3511 is Fatty acids, C18 (saturated and unsaturated) ethyl ester).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Principles of method if other than guideline:
- Repeated insult patch test (human) carried out according to ICH Guideline E6 for Good Clinical Practice. The human skin sensitization test was carried out to evaluate the potential of the test subsnatce (Bioester XP 3511) to induce primary or cumulative irritation and/or allergic contact sensitization by repetative
dermal contact using an induction and challenge phase. - GLP compliance:
- yes
- Remarks:
- Study performed in accordance to GCP
- Type of study:
- other: Repeated insult patch test (human)
Test material
- Reference substance name:
- Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester
- IUPAC Name:
- Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester
- Test material form:
- not specified
- Details on test material:
- Bioester XP 3511
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: Not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Fifty-seven qualified human subjects (male and female) ranging in age from 19 to 78 years, were elected for the evaluation. Fifty subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application to the test material. Subjects not fitted for the study (subjects with skin diseases, medical history etc.) were not included in the study.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- no data
- Concentration / amount:
- The upper back between the scapulae served as the treatment area- 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 apllied to the appropriate treatment site to form a semi-occlusive patch.
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- The upper back between the scapulae served as the treatment area- 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 apllied to the appropriate treatment site to form a semi-occlusive patch.
- No. of animals per dose:
- NA
- Details on study design:
- NA
- Challenge controls:
- NA
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- NA
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 ml
- No. with + reactions:
- 0
- Total no. in group:
- 57
- Clinical observations:
- No effects observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 ml. No with. + reactions: 0.0. Total no. in groups: 57.0. Clinical observations: No effects observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 ml
- No. with + reactions:
- 0
- Total no. in group:
- 57
- Clinical observations:
- No effects observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml. No with. + reactions: 0.0. Total no. in groups: 57.0. Clinical observations: No effects observed.
Any other information on results incl. tables
No adverse effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of this study, test material, Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester), did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.
- Executive summary:
A human patch repeated insult patch test (HRIPT) was performed with Bioester XP 3511 (test substance) in accordance with ICH Guideline E6 for Good Clinical Practice. 57 subjects were included in the study using an inducting and challenge phase.
Patches with 0.2 ml were applied three times per week for a total of nine applications (induction phase) and reading were performed.
Approximately two weeks after the final induction patch application, a challenge pathc was applied to a virgin site adjecent to the originalinduction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two post-application.
Under the conditions of this study, test material, Bioester XP 3511 (Fatty acids, C18 (saturated and unsaturated) ethyl ester) , did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization. Thus, Bioester XP 3511 was concluded to be a non-sensitizer.
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