Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-490-8 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 9 April 2007 to 14 May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
- Principles of method if other than guideline:
- - Principle of test: An intensified version of the Repeat Insult Patch Test regimen conducted under double blind conditions on a panel of more than 100 human subjects.
- Short description of test conditions: Four 24-h applications of the test substance conducted seriatim during each of weeks 1, 2, and 3, and four 24-hour applications of the test substance conducted seriatim on a native site during the challenge week. The contacted skin was examined after each application to assess and grade the elicited effect. During the initial phase the responses that were in evidence after removal of the sample were used to determine whether applications were to be continued on the same site, switched to a new site or terminated.
- Parameters analysed / observed: skin irritation/ inflammation or sensitization - GLP compliance:
- yes
- Type of study:
- skin painting test
Test material
- Reference substance name:
- Fatty acids, C16-18-UNSATD., trimers, tris(16-Methylheptadecyl) esters
- EC Number:
- 600-407-9
- Cas Number:
- 103213-22-5
- IUPAC Name:
- Fatty acids, C16-18-UNSATD., trimers, tris(16-Methylheptadecyl) esters
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS:
In vivo test system
Test animals
- Species:
- other: Human volunteers
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: human volunteers
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation:87 female volunteers between 18-81 years old, 33 male volunteers between 18-81 year old
- Housing: Volunteers returned to the laboratory each day/week
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 150 µL
- Day(s)/duration:
- day 1 of weeks 1, 2, and 3
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 150 µL
- Day(s)/duration:
- day 1 of weeks 5 and 6
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 119 volunteers in the induction phase and 114 volunteers in the challenge phase all exposed to the same dose concentration.
- Details on study design:
- RANGE FINDING TESTS: none
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Dose applied on Monday(s) during weeks 1, 2, and 3 and checked for irritation or other clinical signs on Tuesday, Wednesday, Thursday, and Friday of each week.
- Test groups: 1
- Control group: none
- Site: right upper arm
- Frequency of applications: 1 application per week
- Duration: 24 hours
- Concentrations: 150 µL
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Dose applied on Monday(s) during week 5 and checked for irritation or other clinical signs on Tuesday, Wednesday, Thursday, and Friday of each week.
- Exposure period: a single 24 hour exposure during week 5.
- Test groups: 1
- Control group: none
- Site: right upper arm
- Concentrations: 150 µL
- Evaluation (hr after challenge): 24 hours - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Results
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 150 µL
- No. with + reactions:
- 0
- Total no. in group:
- 114
- Clinical observations:
- No redness or other signs of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The data do not contraindicate exposure of the skin to the product represented by the sample identified as EX-1029 for usages entailing repeated applications under conditions commensurate with or less stringent than those that prevailed during the course of the this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)