Phenethyl phenylacetate

Endpoint summary

Description of key information

Skin Sensitization:

A maximization test was carried out to assess the dermal sensitization potential of the test chemical in humans. The test chemical was applied in concentration 2% in petrolatum to the skin of 25 human volunteers and observed for signs of dermal irritation or sensitization. No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal sensitization potential of the test chemical in humans

GLP compliance:

not specified

Type of study:

other: Human Maximization test

Justification for non-LLNA method:

Not specified

Species:

other: humans

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data available

Route:

other: no data

Vehicle:

petrolatum

Concentration / amount:

2% in petrolatum

Day(s)/duration:

no data available

Adequacy of induction:

not specified

No.:

#1

Route:

other: no data

Vehicle:

petrolatum

Concentration / amount:

2% in petrolatum

Day(s)/duration:

no data available

Adequacy of challenge:

not specified

No. of animals per dose:

25 human volunteers

Details on study design:

no data available

Challenge controls:

no data available

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

Dose level:

2% in petrolatum

No. with + reactions:

0

Total no. in group:

25

Clinical observations:

No sensitization reactions observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.

Executive summary:

A maximization test was carried out to assess the dermal sensitization potential of the test chemical in humans. The test chemical was applied in concentration 2% in petrolatum to the skin of 25 human volunteers and observed for signs of dermal irritation or sensitization. No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studies have been reviewed to ascertain the extent of dermal sensitization caused by the test chemical. These include in vivo experiments performed on humans as well as guinea pigs. The results are as follows:

A maximization test was carried out to assess the dermal sensitization potential of the test chemical in humans. The test chemical was applied in concentration 2% in petrolatum to the skin of 25 human volunteers and observed for signs of dermal irritation or sensitization. No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.

This result is supported by a Repeated insult patch test performed in humans to assess the dermal sensitization potential of the test chemical. 2% of the test chemical was tested using eleven 24 hour exposures to the skin of 40 human volunteers and observed for signs of dermal irritation or sensitization (duration not specified). No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.

The above repeated insult patch test result is also supported by a similar repeated insult patch test was performed in humans to assess the dermal sensitization potential of the test chemical. 2% of the test chemical was tested using eleven 48 hour exposures to the skin of 105 human volunteers and observed for signs of dermal irritation or sensitization (duration not specified). No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.

These results are further supported by a human maximization test carried out to assess the sensitization potential of the test chemical in humans 4% test chemical [2760 µg/cm2] in petrolatum was applied under occlusion to the same site on the forearms of 25 healthy male volunteers for five alternate days, 48 hours periods. The patch sites were pre-treated 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 pre-treated for 1 h with 10% SLS. The challenge site was evaluated at 48 and 72 hours. On evaluation of the challenge site at 48 and 72 hours, no sensitization reactions were observed. Hence, the test chemical was considered to be non-sensitizing to skin in humans.

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.