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Description of key information

Human maximization test was performed on 28 volunteers for test chemical Pentyl Formate (CAS No:638-49-3) to assess its sensitization potential. Each volunteer was exposed to 3% of Pentyl Formate in petrolatum for 48 hours and observed for sensitization effects. None of the volunteers produced any skin sensitizing effects. Hence Pentyl Formate (CAS No: 638-49-3) was considered to benot sensitizing in aHuman maximization test was performed on 28 volunteers.

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 journal.
Qualifier:
equivalent or similar to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Human maximization test was performed on 28 volunteers for test chemical Pentyl Formate (CAS No:638-49-3) to assess its sensitization potential.
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
No data available
Specific details on test material used for the study:
Name of test material (as cited in study report):pentyl formate
- Molecular formula :C6H12O2
- Molecular weight :116.158g/mole
- Substance type:organic
- Physical state:No data available
Purity:No data available
- Impurities (identity and concentrations):No data available
Species:
other: human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
3%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
3%
No. of animals per dose:
28
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified
Statistics:
No data available
Positive control results:
No data available
Reading:
1st reading
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
28
Clinical observations:
No skin sensitizing reaction was observed in 28 volunteers
Remarks on result:
no indication of skin sensitisation
Remarks:
No skin sensitizing reaction was observed in 28 volunteers
Interpretation of results:
other: Not sensitizing
Conclusions:
The test material Pentyl Formate (CAS No: 638-49-3) was considered to be not sensitizing in a Human maximization test was performed on 28 volunteers.
Executive summary:

Human maximization test was performed on 28 volunteers for test chemical Pentyl Formate (CAS No:638-49-3) to assess its sensitization potential.

 

Each volunteer was exposed to 3% of Pentyl Formate in petrolatum for 48 hours and observed for sensitization effects.

 

None of the volunteers produced any skin sensitizing effects. Hence Pentyl Formate (CAS No: 638-49-3) was considered to benot sensitizing in aHuman maximization test was performed on 28 volunteers.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Skin sensitization:

Various studieshas been investigated for the test chemicalPentyl Formate (CAS No: 638-49-3)to observe the potential for skin sensitizationl to a greater or lesser extent. The studies are based on in vivo experiments in humans and guinea pigs for target chemicalPentyl Formate (CAS No: 638-49-3) and its structurally similar read across substances3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2) andButyl Acetate (CAS no: 123-86-4).The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;

D. L. J. Opdyke (1980) conducted Human maximization test on 28 volunteers for test chemical Pentyl Formate (CAS No:638-49-3) to assess its sensitization potential. Each volunteer was exposed to 3% of Pentyl Formate in petrolatum for 48 hours and observed for sensitization effects. None of the volunteers produced any skin sensitizing effects. Hence Pentyl Formate (CAS No: 638-49-3) was considered to benot sensitizing in aHuman maximization test was performed on 28 volunteers.

The OECD QSAR toolbox version 3.3 estimated the skin sensitization potential of target chemical Pentyl Formate (CAS No: 638-49-3) with log kow as the primary descriptor. The substance failed to induce skin sensitization in guinea pigs. Thus Pentyl Formate (CAS No:638-49-3) was estimated to be not sensitizing to the skin of guinea pig.

According to Danish (Q) SAR Database 2016, the sensitization effects were observed for target chemical Pentyl Formate (CAS No:638-49-3) in guinea pig and human. Skin sensitization effects were estimated by four different models i.e, Battery,CASE Ultra, Leadscope and SciQSAR used within Danish QSAR database for chemical Pentyl Formate (CAS No:638-49-3). Based on estimation No skin sensitization effect were known when test chemical Pentyl Formate (CAS No:638-49-3) exposed to Guinea Pig and Human.

The above results were supported byskin sensitization study conducted byD.W. SHARP (1978)in 10 Inbred Hartley strain albino guinea pigs according to modified Draize sensitization test onfor structurally similar substance3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2).For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ]In the induction phase,the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X 0.1). Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC (0.1 and 20 respectively). Twenty-four hours later the reactions were observed.In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, andapparent sensitization reactions confirmed 7 days later by a second challenge with controls included.Based upon the second challenge, it can be concluded that the test3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2) was considered to be not sensitizing to Hartley guinea pigs as no skin reactions were observed.

Cosmetic Ingredient Review Expert Panel (1989) carried out the repeat insult patch test on 26 subjects for structurally similar substance Butyl Acetate (CAS no: 123-86-4) under occlusive condition which further supports the above results. During induction, Butyl Acetate 4% in petrolatum, was applied under an occlusive patch to the forearm and was left in contact with the skin for five alternate-days for 48 h periods. The patch sites were pretreated with a 5% aqueous sodium lauryl sulfate solution under an occlusive 24 h patch. After a non treatment period of 10-14 days, two challenge patches were applied to the upper back for 48 h. One of the challenge patch sites was pretreated with a 30 min application of 5% aqueous sodium lauryl sulfate. The pretreatment with sodium lauryl sulfate produced a slight to moderate degree of irritation. One subject had sweat retention reactions at the pretreated sites, but no other evidence of irritation or sensitization was observed. Hence Butyl Acetate (CAS no: 123-86-4)was considered to be not sensitizing in arepeat insult patch test was conducted on 26 subjects under occlusive condition.

Based on the the available data for target substance Pentyl Formate (CAS No: 638-49-3) and its structurally similar read across substances3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2) andButyl Acetate (CAS no: 123-86-4), it can be concluded that the test chemical substance Pentyl Formate (CAS No: 638-49-3) is not likely to cause skin sensitization and thus can be classified as non-skin sensitizer.

Justification for classification or non-classification

The skin sensitization potential of test substance Pentyl Formate (CAS No: 638-49-3) and its structurally similar read across substances3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2) andButyl Acetate (CAS no: 123-86-4)were observed in various studies. From the results obtained from these studies it is concluded that the chemical Pentyl Formate (CAS No: 638-49-3) was unable to cause skin sensitization and hence can be classified as non-skin sensitizing.