Anisyl formate

Endpoint summary

Description of key information

Human Maximization test was conducted for test chemical Anisyl Formate (CAS No: 122-91-8) on 22 volunteers in order to determine the skin sensitization potential caused by the chemical. Anisyl formate was applied at concentration of 4% in petrolatum on skin of each subject and later observed for skin reactions. None of the subjects showed any cutaneous reaction. Therefore, Anisyl Formate (CAS No: 122-91-8) was considered to be not sensitizing on the skin of 22 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:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Human Maximization test was conducted for test chemical Anisyl Formate (CAS No: 122-91-8) on 22 volunteers in order to determine the skin sensitization potential caused by the chemical.

GLP compliance:

not specified

Type of study:

other: Human Maximization test

Justification for non-LLNA method:

not specified

Specific details on test material used for the study:

- Name of test material: (4-methoxyphenyl)methyl formate/ Anisyl Formate
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mol
- Smiles notation: c1(ccc(OC)cc1)COC=O
- InChl: 1S/C9H10O3/c1-11-9-4-2-8(3-5-9)6-12-7-10/h2-5,7H,6H2,1H3
- Substance type: Organic
- Physical state: Liquid

Species:

other: Human

Strain:

other: Not applicable

Sex:

male

Details on test animals and environmental conditions:

No data available

Route:

other: No data available

Vehicle:

petrolatum

Concentration / amount:

4%

Adequacy of induction:

not specified

Route:

other: No data available

Vehicle:

petrolatum

Concentration / amount:

4%

Adequacy of challenge:

not specified

No. of animals per dose:

22 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:

4%

No. with + reactions:

0

Total no. in group:

22

Clinical observations:

None of the treated volunteers had any skin sensitizing reaction.

Remarks on result:

no indication of skin sensitisation

Cellular proliferation data / Observations:

None of the treated volunteers had any skin sensitizing reaction.

Interpretation of results:

other: Not sensitizing

Conclusions:

The test chemical Anisyl Formate (CAS No: 122-91-8) was considered to be not sensitizing on the skin of 22 volunteers in a Human Maximization test

Executive summary:

Human Maximization test was conducted for test chemical Anisyl Formate (CAS No: 122-91-8) on 22 volunteers in order to determine the skin sensitization potential caused by the chemical.

 

Anisyl formate was applied at concentration of 4% in petrolatum on skin of each subject and later observed for skin reactions.

 

None of the subjects showed any cutaneous reaction. Therefore, Anisyl Formate (CAS No: 122-91-8) was considered to be not sensitizing on the skin of 22 volunteers.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization:

Various studieshas been investigated for the test chemical(4-methoxyphenyl)methyl formate /Anisyl Formate (CAS No: 122-91-8)to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemicalAnisyl Formate (CAS No: 122-91-8) and its structurally similar read across substancesBenzyl formate (CAS No: 104-57-4)and p-anisyl acetate (CAS No: 104-21-2).The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;

D.L.J. Opdyke (1976) conducted Human Maximization test for target chemical Anisyl Formate (CAS No: 122-91-8) on 22 volunteers in order to determine the skin sensitization potential caused by the chemical. Anisyl formate was applied at concentration of 4% in petrolatum on skin of each subject and later observed for skin reactions. None of the subjects showed any cutaneous reaction. Therefore, Anisyl Formate (CAS No: 122-91-8) was considered to be not sensitizing on the skin of 22 volunteers.

 

 

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, theskin sensitizing potential ofchemicalAnisyl Formate (CAS No: 122-91-8) was estimated in guinea pigs. Based on the estimated results, Anisyl Formate (CAS No: 122-91-8) can be considered to be not sensitizing to skin.

 

 

According to Danish QSAR database , skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for Anisyl Formate (CAS No: 122-91-8) . Based on estimation, No skin sensitization reaction were observed in guinea pigs and humans. Therefore, Anisyl Formate (CAS No: 122-91-8) was considered to be not sensitizing.

 

 

The above results were supported by theexperimental studyconducted by D.W. SHARP (1978)inHartley albinoguineapigsforstructurally similar read across substanceBenzyl formate (CAS No: 104-57-4) by using Modified Draize Technique. In this test,the preliminary irritation tests were performed in 8 guinea pigs to determine concentrations suitable for sensitization test [injection challenge concentration(ICC) and application challenge concentration(ACC) ].As a result of the preliminary studies, the concentration selected for skin sensitization test were 0.25% forICC and 20% for ACC.During the induction phase,the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X 0.25%). 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 (0.25 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 and confirmatory challenge with controls included.At 24 hours after the first challenge and at the second and confirmatory challengewith 0.25% and 20%Benzyl formate,none of the rabbits showed positive results. Thus, it can be concluded that theBenzyl formate (CAS No: 104-57-4)was considered to be not sensitizing onguinea pigs.

 

 

D. McGinty, C.S. Letizia,A.M. Api (2012) reporteda Human Maximization testofstructurally similar read across substancep-anisyl acetate (CAS No: 104-21-2)on25 patients which further supports the above results.In the induction phase of a maximization study, a concentration of 10% (6900 lg/cm2) p-anisyl acetate was applied on the forearms or backs of all subjects for five alternate- day, 48 h periods under occlusive condition.The site was pretreated for 24 h with 5% sodium lauryl sulfate. Following a 10–14 day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours at a dose of 10% p-anisyl acetate. Reactions were evaluated at patch removal and 24 h thereafter. Since the chemical did not produce any skin sensitizing reaction in any of the treated subject, chemicalp-anisyl acetate(CAS No: 104-21-2)was considered to be not sensitizing on the skin of 25 volunteers in a Human Maximization test.

 

 

Thus on the basis of available data for the target chemical Anisyl Formate (CAS No: 122-91-8) and its structurally similar read across substancesBenzyl formate (CAS No: 104-57-4)andp-anisyl acetate (CAS No: 104-21-2),it can be concluded thatchemical Anisyl Formate (CAS No: 122-91-8) is unable to cause skin sensitization and considered as non skin sensitizer.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Anisyl Formate (CAS No: 122-91-8) and its structurally similar read across substancesBenzyl formate (CAS No: 104-57-4)andp-anisyl acetate (CAS No: 104-21-2)were observed in various studies. From the results obtained from these studies it is concluded that the chemical Anisyl Formate (CAS No: 122-91-8) is not likely to cause skin sensitization and hence can be classified as non skin sensitizer.