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EC number: 611-930-7 | CAS number: 60045-26-3
The SI (test/control ratios) obtained for 25, 50% v/v and ‘as supplied’ 3-Phenylpropyl benzoate were 0.9, 1.6 and 6.3 respectively. As a SI of 3 or more was recorded for the highest concentration tested (as supplied), 3-Phenylpropyl benzoate was considered to have the potential to cause skin sensitization. Based on the results of this study the EC3 value is calculated to be 64.9% v/v. The SI for the positive control substance hexyl cinnamic aldehyde (HCA) was 6.5 which demonstrates the validity of this study.
3-Phenylpropyl benzoate is regarded as a potential skin sensitizer
A weight of evidence assessment of the skin sensitization hazard of 3-PPB (Earl, 2015 see attached document below) has been generated to ensure that the correct decision is taken on the classification of 3-PPB as a skin sensitiser/non sensitiser. The report contains a review of LLNA accuracy of predictions, physicochemical and hazard data of the substance, its metabolites and impurities and closely related substances and computational prediction tools to detect skin sensitisation structural alerts. It was concluded on the basis of this weight of evidence that 3-PPB does not have significant skin sensitisation potential and should not be classified as a skin sensitizer.
A LLNA study performed with 3-PPB is available and shows a weak positive response with the undiluted 3-PPB and a EC3 value of 64.9%, therefore 3 -phenyl propyl benzoate could be classified as a skin sensitiser 1B ( EC3 value > 2 %) according to EU Regulation 1272/2008. However the possibility for the LLNA result with 3-PPB to be a false positive was assessed in a weight of evidence approach described in the expert judgement report attached below (Earl, 2015). Like all hazard identification tests the LLNA has been associated with some false positive reactions. A brief review of the available literature identified several examples of substances which have been identified as false positives in the LLNA. The comparison of 3-PPB with structurally similar substances showed a trend in structural alerts for skin sensitization using publicly available commonly used expert systems with the shorter alkyl chain between the 2 aromatic rings producing structural alerts in benzyl benzoate and phenyl benzoate. However, neither 3-PPB nor its likely metabolites are predicted to be skin sensitisers and experimental in vivo data obtained in LLNAs or in human studies with 3-PPB structural analogues demonstrated a weak or no sensitising effect. The weak positive response with only the undiluted 3-PPB applied (lower concentrations were negative) highlighted the possibility that the LLNA result for 3-PPB was either a false positive or there was an impurity in the substance that was tested which triggered the response. In view of the product analysis result which showed that the tested batch was 99.1% pure and the evaluation of the skin sensitization information on the typical range of product impurities/constituents, there was insufficient evidence to conclude the presence of a sensitising impurity in the tested product. The evidence supports the conclusion that the positive result for 3-PPB in the LLNA is likely to be a false positive. Given the consistent evidence of lack of hazard from similar structures and metabolites of 3-PPB, the weight of evidence leads to the conclusion that 3-PPB is not a hazard for skin sensitization. Therefore no classification is proposed.
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