Short-term toxicity of isoamyl salicylate in rats

Drake, J.J.-P.; Gaunt, I.F.; Butterworth, K.R.; Hooson, Jean; Hardy, Joan; Gangolli, S.D.

doi:10.1016/s0015-6264(75)80003-4

Cited by 21 publications

(10 citation statements)

References 6 publications

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“…[27,28] The hydrolysis rate of straight-chain esters is approximately 100 times greater than that of their branched-chain counterparts. [29] Select isoenzymes exhibit an increase in enzyme binding (lower Km) and maximum velocity (Vmax) as the carbon chain length of either the alcohol or carboxylic acid component of the substrate increases. [12] Evidence pertaining to the in vivo metabolic profile of benzyl acetate suggests that hydrolysis of the parent compound proceeds rapidly, yielding substrates which undergo ready conjugation and elimination.…”

Section: Toxicokinetic Similaritymentioning

confidence: 99%

Read-across of 90-day rodent repeated-dose toxicity: A case study for selected simple aryl alcohol alkyl carboxylic acid esters

Firman

Patel

Date

et al. 2018

Computational Toxicology

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Aryl alcohol alkyl carboxylic acid esters constitute a wide-employed class of fragrance materials. Outcomes presented within this study illustrate formulation of a read-across protocol for 90-day, repeat-dose toxicity within a series of these compounds, extending in scope to the dodecanoic acid esters of both benzyl and 2-phenylethyl alcohol. Central to the filling of data gaps is the hypothesis that adverse impact-mediated through mechanisms analogous to narcosis-associated non-specific basal cytotoxicity-is as a consequence of the hydrolysis of parent compounds to their corresponding alcohol. High-quality in vivo data (equivalent to either OECD Test Guideline 408 or 411) relating the toxicodynamic and toxicokinetic profiles of benzyl alcohol, 2-phenylethyl alcohol and benzyl acetate within rodents were retrieved, permitting extrapolation to each ester derivative with great confidence. NOAEL values of 250-500 mg/kg/day were assigned to esters, with a greater toxicity present within females. In order to greater enhance reliability, further theoretical support for the read-across prediction is provided through the integration, where appropriate, of in vitro and in silico data.

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Section: Toxicokinetic Similaritymentioning

confidence: 99%

Read-across of 90-day rodent repeated-dose toxicity: A case study for selected simple aryl alcohol alkyl carboxylic acid esters

Firman

Patel

Date

et al. 2018

Computational Toxicology

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“…Effects confirmed at levels of 2 % and 1.12 % but not at lower (unspecified) levels. Rat; M, 13 weeks 5 (Drake et al, 1975) Published non-GLP study of good quality. Reduced body weight gain at 0.5 % associated with reduced food intake.…”

Section: Annex Iv: Toxicitymentioning

confidence: 99%

“…Oral 0.07, 0.21 % in the diet (0, 35 100) 21 2 years 100 2 (Packman et al, 1961) Only abstract available with very limited report of study details and results. EFSA Journal 2012;10(12):2994 13 weeks 5 (Drake et al, 1975) Published non-GLP study of good quality. Reduced body weight gain at 0.5 % associated with reduced food intake.…”

Section: Rat; M F 50mentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 20, Revision 4 (FGE.20Rev4): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

Publication¹

2012

EFS2

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[FL no: 09.858]. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all the substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 45 candidate substances. Twenty-five flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intake" (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a "modified Theoretical Added Maximum Daily Intake" (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels.According to the default MSDI approach, the 41 flavouring substances allocated to structural class I have intakes in Europe from 0.001 to 610 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day). The four substances in structural class II 05.066, 05.221 and 06.104] have estimated intakes of 0.011, 1.2, 0.61 and 100 microgram/capita/day, respectively. These intakes are below the threshold values of 540 microgram/person/day for structural class II.

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“…Study protocols fully described, results not reported in detail but only summarised in text. EFSA Journal 2011; 9(7):2176 13 weeks 5 (Drake et al, 1975) Published non-GLP study of good quality. Reduced body weight gain at 0.5 % associated with reduced food intake.…”

Section: Annex Iv: Toxicitymentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 20, Revision 3(FGE.20Rev3): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

Publication¹

2011

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider in this revision 3 of Flavouring Group Evaluation 20, the SCF Opinion on benzoic acid. Furthermore information on stereoisomeric composition for two substances and new information to support the re-allocation of the structural class for the candidate substance piperonyl alcohol ] has been submitted. The 41 flavouring substances in Flavouring Group Evaluation 20 were evaluated using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all the substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Twenty-two of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intake" (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a "modified Theoretical Added Maximum Daily Intake" (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels.According to the default MSDI approach, the 37 flavouring substances allocated to structural class I have intakes in Europe from 0.001 to 610 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day). The four substances in structural class II 05.066, 05.221 and 06.104] have estimated intakes of 0.011, 1.2, 0.61 and 100 microgram/capita/day, respectively. These intakes are below the threshold values of 540 ...

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Short-term toxicity of isoamyl salicylate in rats

Cited by 21 publications

References 6 publications

Read-across of 90-day rodent repeated-dose toxicity: A case study for selected simple aryl alcohol alkyl carboxylic acid esters

Read-across of 90-day rodent repeated-dose toxicity: A case study for selected simple aryl alcohol alkyl carboxylic acid esters

Scientific Opinion on Flavouring Group Evaluation 20, Revision 4 (FGE.20Rev4): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

Scientific Opinion on Flavouring Group Evaluation 20, Revision 3(FGE.20Rev3): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

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