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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

A maximization test was carried out on 25 volunteers. The p-tolyl acetate (CAS No. 140-39-6) was tested at 4% concentration in petrolatum and produced no sensitisation reactions. Thus, it is not classified as skin snsitizer as per CLP regulation.

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:
no guideline available
Principles of method if other than guideline:
A maximization test was carried out with p-tolyl acetate on 25 human subjects.
GLP compliance:
not specified
Type of study:
other: Maximization test
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): 4-methylphenyl acetate
- Molecular formula: C9H10O2
- Molecular weight: 150.176 g/mol
- Substance type: Organic
- Physical state: Liquid
Species:
other: Human
Strain:
other:
Remarks:
Not applicable.
Sex:
not specified
Details on test animals and environmental conditions:
No data available.
Route:
other: No data available.
Vehicle:
petrolatum
Concentration / amount:
4%
Day(s)/duration:
No data available
Route:
other: No data available.
Vehicle:
petrolatum
Concentration / amount:
4%
Day(s)/duration:
No data available.
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
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No sensitization was observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not sensitizing
Conclusions:
The p-tolyl acetate (CAS No. 140-39-6) was tested at 4% concentration in petrolatum and produced no sensitisation reactions.
Executive summary:

A maximization test was carried out on 25 volunteers. The p-tolyl acetate (CAS No. 140-39-6) was tested at 4% concentration in petrolatum and produced no sensitisation reactions. Thus, it is not classified as skin snsitizer as per CLP regulation.

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

In various studies, p-tolyl acetate (CAS No. 140-39-6) has been investigated to observe the potential for skin sensitization to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents for p-tolyl acetate along with the study available on structurally similar read across substance benzyl propionate (CAS No. - 122-63-4). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data. The studies are summarized as below:

 

A maximization test was carried out by D. L.J Opdyke (Food and Cosmetics Toxicology, Volume 12, Issue 3, June 1974, Page 391) on 25 volunteers. The p-tolyl acetate (CAS No. 140-39-6) was tested at 4% concentration in petrolatum and produced no sensitisation reactions.

 

In another study the skin sensitization potential of p-tolyl acetate (140-39-6) was estimated by SSS (2017) using OECD QSAR toolbox v3.4 with log kow as the primary descriptor and considering the five closest read across substances. No skin reactions indicative of sensitisation in guinea pigs

were predicted.

 

Similarly, skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for p-tolyl acetate (CAS No.-140-39-6). Based on the estimation, no skin sensitization reactions were observed in guinea pigs and humans.

 

Moreover, in the study by D. McGinty et al. (Food and Chemical Toxicology 50 (2012) S486–S490) on a structurally similar read across substance benzyl propionate (CAS No. - 122-63-4), the maximization test was carried out with 4% (2760 µg/cm2) benzyl propionate in petrolatum on 25 healthy male patients. On evaluation of the challenge site at 48 and 72 hrs no sensitization reactions were observed. Thus, from the study it can be concluded that benzyl propionate (CAS No. - 122-63-4) is not a skin sensitizer.

 

So, based on the above mentioned studies for target substance p-tolyl acetate (CAS No. 140-39-6) and to its read across substance, no skin reactions indicative of sensitisation were found in humans and in guinea pigs. Thus, according to CLP regulation, it infers that p-tolyl acetate (CAS No. 140-39-6) is not a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to CLP Regulation EC No. 1272/2008 and based on the human and animal studies, it is concluded that the substancep-tolyl acetate (CAS No. 140-39-6)is not classified as skin sensitizer.