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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 954-736-0 | 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: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- The substance is intended for use only in cosmetics and has been tested on humans in a patch test.
This class of polyolefin substance is well documented and in line with other non-aromatic white oils, their use in medicinal and cosmetic use is well documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Human patch test
- Principles of method if other than guideline:
- To prove the absence of the skin primary and cumulative irritation potential and skin sensitization of a product under maximized conditions, with
controlled product amount and application site, - GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- hume study - animal testign is not considered appropriate
Test material
- Reference substance name:
- Isoalkanes, C17 -C22 linear and branched
- EC Number:
- 954-736-0
- Molecular formula:
- C17H36 x C22H46
- IUPAC Name:
- Isoalkanes, C17 -C22 linear and branched
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- BioShineBA22-SFD TM
In vivo test system
Test animals
- Species:
- other: Human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Female and male subjects, aged from 18 to 68 years old (mean age: 41
years old), phototypes II to IV
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted - applied to 10 cm2 patch and applied to the skin
- Day(s)/duration:
- 9 applications of 3 weeks
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted material applied to patches and held in place 48 hours
- Day(s)/duration:
- 2
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 59 completed the study
- Details on study design:
- Induction Period: The applications were performed on Mondays, Wednesdays and Fridays, during 3 consecutive weeks. Forty-eight hours
(48h), or 72h (on weekends), after the product application, it was removed by trained technicians and the application site was assessed in order to check the presence of possible clinical signs.
Rest Period: After the induction there was a minimum 10 day-period when no product was applied to the study subjects' back.
Challenge Test: Then, the challenge period started. One single application of the investigational product was carried, followed by readings after 48h
and 72h of the product being attached to the subjects' dorsum.
The dermatological clinical assessment was made in the beginning and end
of the study and the subjects were supervised by a dermatologist throughout
the study. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Un diluted
- No. with + reactions:
- 0
- Total no. in group:
- 59
- Clinical observations:
- No adverse effects
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Some subjects presented irritation after the continuous exposure of the skin to the adhesive tape (adhesive plaster), probably due to individual predisposition, and for this reason the applications were interrupted and their data not used in the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No adverse effects observed from a well-documented clinical trial.
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.