Registration Dossier
Registration Dossier
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EC number: 954-736-0 | CAS number: -
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.
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