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Toxicological information

Skin sensitisation

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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:
2020
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

Constituent 1
Chemical structure
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
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.