Benzyl propionate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

A maximization test was carried out with 4% (2760 µg/cm2) benzyl propionate in petrolatum on 25 healthy male patients

GLP compliance:

not specified

Type of study:

other: maximization test

Species:

human

Strain:

not specified

Sex:

male

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

4% = 2760 µg/cm2

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

4% = 2760 µg/cm2

No. of animals per dose:

25 males

Details on study design:

Application was under occlusion to the same site on the forearms of all subjects for five alternate day, 48 h periods. The patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied to fresh sites on the back for 48 h under occlusion. The challenge site was pretreated for 1 h with 10% SLS. The challenge site was evaluated at 48 and 72 h

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

4% (2760 µg/cm2)

No. with + reactions:

0

Total no. in group:

25

Clinical observations:

No sensitization reactions on evaluation of the challenge site at 48 and 72 hrs

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 4% (2760 µg/cm2) . No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: No sensitization reactions on evaluation of the challenge site at 48 and 72 hrs .

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Maximization test was carried out with 4% (2760 µg/cm2) benzyl propionate in petrolatum on 25 healthy males. On evaluation of the challenge site at 48 and 72 hrs no sensitization reactions were observed. Thus suggesting that benzyl propionate was non sensitizing to skin in humans.

Executive summary:

Maximization test was carried out with 4% (2760 µg/cm2) benzyl propionate in petrolatum on 25 healthy males. On evaluation of the challenge site at 48 and 72 hrs no sensitization reactions were observed. Thus suggesting that benzyl propionate was non sensitizing to skin in humans.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Results of the Supporting studies:

In the Maximization test on healthy males no sensitization reactions were observed, also no allergic reaction were reported in a closed patch test with 38 patients with contact dermatitis, and no positive response reported in the Open Epicutaneous Test in the guinea pigs.

Migrated from Short description of key information:

The substance, benzyl propionate is found to be non sensitising to human males in a Maximization test.

Justification for selection of skin sensitisation endpoint:

Data is from a reliable data source from publication journal of Food and Chemical Toxicology

Justification for classification or non-classification

The available studies indicate that the test substance, benzyl propionate is non sensitising to skin and hence is being classified as 'Non sensitising' as per the CLP classification.