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Administrative data

Description of key information

The skin sensitization potential of target chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8) was assessedin various experimental studies which were conducted on guinea and humans for target chemical2-Methoxybenzyl alcohol (CAS no: 612-16-8) and its structurally similar read across substancesAnisic alcohol (CAS No: 105-13-5) and Methyl benzoate (CAS No: 93-58-3)..Based on the available data for the target and read across substances and applying the weight of evidence approach, it can be concluded that chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8) is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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:
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 journal
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A human repeated insult patch test (HRIPT) was conducted on 39 volunteers to assess the contact sensitization potential of chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8).
GLP compliance:
not specified
Type of study:
other: Human Repeated Insult Patch Test (HRIPT)
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-Methoxybenzyl alcohol
- Molecular formula: C8H10O2
- Molecular weight: 138.165 g/mol
- Substance type: Organic
- Physical state: liquid
-Smiles: O(c1c(cccc1)CO)C
-InChI: 1S/C8H10O2/c1-10-8-5-3-2-4-7(8)6-9/h2-5,9H,6H2,1H3
Species:
other: Human
Strain:
other: Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
epicutaneous, occlusive
Vehicle:
other: Ethyl alcohol (EtOH)
Concentration / amount:
1.2%
Day(s)/duration:
3 Weeks
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Ethyl alcohol (EtOH)
Concentration / amount:
1.2%
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
39 subjects
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
- Test groups: 39 subjects
- Control group: no data
- Site: no data
- Frequency of applications: 3 times/week
- Duration: 3 weeks
- Concentrations: 1.2%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: 24 hours
- Test groups: 39 subjects
- Control group: no data
- Site: no data
- Concentrations: 1.2%
- Evaluation (hr after challenge): after24 hours
Challenge controls:
not specified
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1.2%
No. with + reactions:
0
Total no. in group:
39
Clinical observations:
None of the volunteers showed any signs of contact sensitization.
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
None of the volunteers showed any signs of contact sensitization.
Interpretation of results:
other: Not sensitizing
Conclusions:
None of the volunteers had showed any signs of skin sensitization. Hence the chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8) was considered to be not sensitizing to the skin of human subjects.
Executive summary:

A human repeated insult patch test (HRIPT) was conducted on 39 volunteers to assess the contact sensitization potential of chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8).

 

Each subject was induced with1.2% of2-Methoxybenzyl alcohol inEtOH three times per week for 3 weeks under occlusive condition. After induction, all the treated subjects were challenged at same concentration used in induction and later observed for skin reactions after 24 hours.

 

 

None of the volunteers showed any signs of skin sensitization. Hence the chemical2-Methoxybenzyl alcohol (CAS no: 612-16-8) was considered to be not sensitizing to the skin of human subjects.

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

Skin sensitization

Various studieshas been investigated for the test chemical2-Methoxybenzyl alcohol (CAS no: 612-16-8)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 chemical2-Methoxybenzyl alcohol (CAS no: 612-16-8) and its structurally similar read across substancesAnisic alcohol (CAS No: 105-13-5) and Methyl benzoate (CAS No: 93-58-3) which have been summarized as below;

 

The D. Belsito et al., {Food and Chemical Toxicology, Vol. 50, Pg. no. S52-S99, 2012} conducted ahuman repeated insult patch test (HRIPT) on 39 volunteers to assess the contact sensitization potential of target chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8). During the study, each subject was induced with1.2% of2-Methoxybenzyl alcohol inEtOH three times per week for 3 weeks under occlusive condition. After induction, all the treated subjects were challenged at same concentration used in induction and later observed for skin reactions after 24 hours.None of the volunteers showed any signs of skin sensitization. Hence the chemical2-Methoxybenzyl alcohol (CAS no: 612-16-8) was considered to be not sensitizing to the skin of human subjects.

 

TheD.W. SHARP {Toxicology, 9 (1978) 261-271} carried out theskin sensitization study of read across substanceAnisic alcohol (CAS No: 105-13-5)in 10 Inbred Hartley strain albino the guinea pigs according modified Draize sensitization test which supports the above mentioned result.The 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 0.25). 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 10 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 theAnisic alcohol (CAS No: 105-13-5)was considered to be non-sensitizingto the skin of albino Hartley guinea pigs at 0.25% ICC and 10% ACC concentrations.

 

 

The above results were further supported by an Open Epicutaneous Test (OET) performed on guinea pigs G. Klecak {Curr. Probl. Derm., vo1.14, pp.152-171 (Karger, Basel 1985)} for read across substance Methyl benzoate (CAS No: 93-58-3).The pretest was performed to determine the primary irritating threshold concentration of test substances at various concentrations (e.g, 100,30,10 and 3%). In this test, a single application of 0.025 ml of each test concentration was simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of pretest, the concentration selected for sensitization test was 4 %.On day 1 during induction, 0.1 ml of the Ethyl benzoate (CAS No: 93-89-0) was applied at concentrations of 4% in vehicle to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week. To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of chemical to skin areas measuring 2 cm2. The reactions were read after 24,48 and/or 72h. It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 4%.Thus the chemicalMethyl benzoate (CAS No: 93-58-3) was considered to be not sensitizing on skin of guinea pigs at concentration of 4% in an Open Epicutaneous Test (OET).

 

 

Based on the available data for the target chemical, supporting studies and read across substance,it can be concluded thatchemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8) is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance 2-Methoxybenzyl alcohol (CAS no: 612-16-8) and its structurally similar read across substancesAnisic alcohol (CAS No: 105-13-5) and Methyl benzoate (CAS No: 93-58-3) were observed in various studies. From the results obtained from these studies it is concluded that the chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.