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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference Type:
study report

Materials and methods

Type of study / information:
The objective of the study was to evaluate if the potential of the test material to cause cutaneous irrition after a single 24 h patch application, on the skin of healthy volunteers.
Endpoint addressed:
skin irritation / corrosion
Test guideline
no guideline followed
Principles of method if other than guideline:
A single application of each of the test materials will be made to designated skin sites (arms) for approximately 24 hours.
Sites will be evaluated approximately 15 minutes and 24 hours after patch removal.
Reactions will be evaluated according to a numerical scale based upon the degree of irritation.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Waxes and Waxy substances, jojoba, iso-Pr esters
EC Number:
Cas Number:
Molecular formula:
No molecular formula available (UVCB)
Waxes and Waxy substances, jojoba, iso-Pr esters
Details on test material:
Substance %
Isopropyl Jojobate 30 – 40
Jojoba Alcohols 30 – 40
Jojoba Esters 30 – 40


Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
* 15 healthy male/female subjects of 18 years of age or older

* Positive control: sodium lauryl sulfate 0.3% in distilled water (w/v)
* Negative control: deionized water
Exposure assessment:
Details on exposure:
* 0.2 mL applied by pipette or syringe
* occluded using a non woven cotton pad covered by and held securely on all sides with an occlusive hypoallergenic tape

Results and discussion

At 15 minutes after path removal, 1 out of 15 subjects presented with a slight, confluent, patchy erythema and another subject presented glazing skin.
At 24 hours after patch removal, no irritation signs were observed in any of the 15 subjects.

Applicant's summary and conclusion

Floraesters IPJ is not irritatant to human skin.