Phenethyl acetate

Sensitisation data (human)

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.

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.