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Table 5 Toxicological thresholds selected for calculating the margin of exposure

From: Electronic cigarettes: overview of chemical composition and exposure estimation

Agent Toxicological Endpointa Value [mg/kg bw/day] Type of endpointb Reference
Nicotine Heart rate acceleration in humans 0.008 LOAELc EFSA [30] based on Lindgren et al. [42]
0.0008 ADI
Glycerol 2-year study in rats, no effects observed 10,000 NOAEL OECD SIDS [31] based on Hine et al. [43]
1,2-Propanediol 2-year studies in rats and dogs, no effects observed in rats, increased erythrocyte destruction in dogs 2,500 NOAEL JECFA [32] based on Gaunt et al. [44] and Weil et al. [45]
25 ADI
Ethylene glycol Developmental toxicity data in mice (total malformations and a skeletal variation) 76 BMDL10 ATSDR [33] based on Neeper-Bradley et al. [46] and Tyl et al. [47]
0.8 MRL
1,3-Propanediol Developmental toxicity study in rats 1,000 NOAEL EFSA Panel on Contaminants in the Food Chain [34] based on unpublished data
Thujone Clonic seizures in rats 11 BMDL10 Lachenmeier and Uebelacker [36] based on NTP [48]
0.11 ADI
Ethyl vanillin 13-week study in rats, no effects observed 500 NOEL JECFA [35] based on unpublished data
  1. aHuman data was preferred over animal data, if available. The most sensitive endpoint was chosen if dose–response data for several organ sites were available.
  2. bBMDL10: lower one-sided confidence limit of the benchmark dose (BMD) for a 10% incidence of health effect. The No Effect Level (NOEL) or No Observed Adverse Effect Level (NOAEL) are used in cases when no usable BMD-modelling for oral exposure was identified in the literature. ADI: acceptable daily intake. MRL: minimal risk level.
  3. cThe lowest observed adverse effect level (LOAEL) is considered by EFSA [30] as close to the NOAEL. The values were derived from a study in humans who were injected nicotine intravenously assuming an oral bioavailability of 44%.