Benzyl butyrate

Endpoint summary

Description of key information

A maximization test was carried out with 4% (2760µg/cm2) test chemical in petrolatum on 25 healthy male patients. 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 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 h.No sensitization reactions were observed. Hence, the test chemical can be considered to be not sensitizing to the skin of humans.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

A maximization test was carried out to assess the dermal sensitization potential of test chemical in humans

GLP compliance:

not specified

Type of study:

other: Maximization test

Justification for non-LLNA method:

not specified

Species:

other: humans

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

No data available

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

4% (2760 µg/cm2)

Day(s)/duration:

5 alternate days, 48 hours exposure

Adequacy of induction:

other: The patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

4% (2760 µg/cm2)

Day(s)/duration:

48 hours

Adequacy of challenge:

other: The challenge site was pretreated for 1 h with 10% SLS.

No. of animals per dose:

25 humans

Details on study design:

Details on study design
RANGE FINDING TESTS:no data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data available
- Exposure period: five alternate day at 48 h periods.
- Test groups: 25
- Control group: No data available
- Site: forearm
- Frequency of applications: 5 alternate days
- Duration: 48 hrs
- Concentrations: No data available


B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: 10 days
- Exposure period: No data available
- Test groups: 25
- Control group: No data available
- Site: On the fresh sites of back
- Concentrations: No data available
- Evaluation (hr after challenge): 48 and 72 hrs

OTHER:
A. INDUCTION EXPOSURE
The patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion.

B. CHALLENGE EXPOSURE
The challenge site was pretreated for 1 h with 10% SLS.

Challenge controls:

No data available

Positive control substance(s):

not specified

Positive control results:

No data available

Key result

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

4% (2760 µg/cm2)

No. with + reactions:

0

Total no. in group:

25

Clinical observations:

No sensitization reactions were observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

No sensitization reactions were observed. Hence, the test chemical can be considered to be not sensitizing to the skin of humans

Executive summary:

A maximization test was carried out with 4% (2760µg/cm2) test chemical in petrolatum on 25 healthy male patients. 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.No sensitization reactions were observed. Hence, the test chemical can be considered to be not sensitizing to the skin of humans

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin Sensitization

Various studies have been evaluated to determine the degree of sensitization caused by the test chemical. These include in vivo experimental studies performed on humans for the test chemical. The results are mentioned below:

A maximization test was carried out with 4% (2760µg/cm2) test chemical in petrolatum on 25 healthy male patients. 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 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 h.No sensitization reactions were observed. Hence, the test chemical can be considered to be not sensitizing to the skin of humans.

This result is supported by a similar human maximisation test carried out in 25 volunteers to determine skin sensitization potential caused by the test chemical. Each subject was treated with 4% of test chemical in petrolatum dermally and later observed for any signs of contact allergy.None of the volunteer showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

These results are supported by a 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 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.

All of the above results are further supported by a maximization test was 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, the test chemical can be considered to be not sensitizing to skin and 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, the test chemical can be considered to be not sensitizing to skin and classified under the category “Not Classified” as per CLP Regulation.