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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Insufficient methods or results details. Study completed prior to introduction of formal test guidelines or GLP principles. The report is a synopsis of results rather than a full study report and does not contain all the information normally provided in a GLP compliant report.

Data source

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Maximisation test completed in 20 human volunteers. The methods were standard for the repeat insult patch test.
GLP compliance:
no

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
Twenty-five adult healthy male volunteers were allocated to the study but 5 did not complete the study.
Clinical history:
25 human volunteers started and 20 finished the study.
Controls:
No data
Route of administration:
dermal
Details on study design:
The human patch test was conducted using closed epicutaneous test methods in accordance with the Maximisation Test (J.I.D Vol. 5; 1968) of Kligman
epicutaneous, occlusive covering
Patch test used the vehicle, petrolatum, as the vehicle control.

Results and discussion

Results of examinations:
No information for positive controls

48 and 72 hour human patch test response - test group - concentration of test substance 10% in petrolatum: 0/20 positive responders



Any other information on results incl. tables

Following maximised exposure to twenty human volunteers, none of the subjects showed any evidence of a sensitisation response.

It was concluded that the allergenic potential for the fragrance substance is very low.

Applicant's summary and conclusion

Conclusions:
The allergenic potential of phenyl ethyl acetate is concluded to be very low following no positive responders in a maximisation test with twenty human volunteers.
Executive summary:

Twenty human volunteers completed a maximisation test for allergenicity potential in which phenyl ethyl acetate was applied five times to the forearm at 10% in petrolatum in the induction phase, followed by challenge application to the dorsum again at 10% in petrolatum.

No reactions indicative of an allergic contact dermatitis were recorded.