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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Developmental toxicity study in rats 1,000 NOAEL EFSA Panel on Contaminants in the Food Chain [34] based on unpublished data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Ethyl vanillin 13-week study in rats, no effects observed 500 NOEL JECFA [35] based on unpublished data
3 ADI
  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%.