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EC number: 204-825-9 | CAS number: 127-18-4
The critical effects of tetrachloroethylene are kidney, liver and central nervous system effects. Based on all available data, there is no clear evidence from studies in humans for repeated dose effects of tetrachloroethylene at exposure levels up to a level of 20 ppm (138 mg/m3) (8 hr TWA).Regarding oral exposure, no human data are available. Regarding animal data, an oral LOAEL of 390 mg/kg bw/day has been identified from the mouse oral cancer bioassay based on kidney damage.
There is a relatively large amount of information on the potential repeated dose effects of tetrachloroethylene from studies in humans and from inhalation and oral studies in animals.
In relation to the studies in humans, there are general worker health surveys and studies specifically investigating potential effects on the liver, kidney, nervous system and colour vision. Variable results and interpretational difficulties have arisen in surveys of workers exposed to lower (below 100 ppm, 690 mg/m3) concentrations of tetrachloroethylene, with a study finding no effects on the frequency of subjective symptoms, psychomotor test results and markers of liver and kidney toxicity in dry-cleaners with a mean 8-hour TWA exposure of 21 ppm (145 mg/m3for 6 years) compared with an unexposed control group (Lauwerys et al., 1983). Two specific hepatotoxicity studies (Gennari et al., 1992 and Brodkin et al., 1995) have provided no clear evidence for tetrachloroethylene-induced liver toxicity at exposure concentrations below 50 ppm (339mg/m3; mean 8h TWA). Similarly, the specific six nephrotoxicity studies (Trevisan et al., 2000; Verplanke et al., 1999; Mutti et al., 1992; Solet and Robins, 1991; Vyskocil et al., 1990; Franchini et al., 1983) have provided no convincing evidence for tetrachloroethylene-induced kidney toxicity at mean exposure levels in the range 1.2 – 23 ppm (8.3 – 156 mg/m3). From the studies that have specifically investigated the potential effects of tetrachloroethylene on the nervous system (Echeverria et al., 1995; Ferroni et al., 1992; Seeber, 1989; Tuttle et al., 1977; Stewart et al., 1977; Altmann et al., 1990; Altmann et al., 1992; Altmann et al., 1995), a clear association between neurobehavioural/neurological deficits and repeated exposure to tetrachloroethylene in the workplace (dry-cleaners) at exposure levels up to 67 ppm (462 mg/m3for 10 years) or in volunteers at concentrations up to 150 ppm (1035 mg/m3for 7.5 hours/day for 5 days) has not been established. There are very few studies that have specifically investigated the effects of tetrachloroethylene on colour discrimination, such that no reliable conclusions can be drawn.
In relation to the animal studies, the liver, kidneys and lungs have been shown to be the main target organs of tetrachloroethylene-induced toxicity. Liver damage seen in mice following either inhalation exposure or oral administration has been shown to involve peroxisomal proliferation, an effect to which humans are not responsive. No liver toxicity was observed in rats. For kidney damage, which was observed in both rats and mice following either inhalation or oral exposure, an inhalation LOAEC of 100 ppm, 690 mg/m3(equivalent to an internal dose of 345 mg/kg/day) and an oral LOAEL of 390 mg/kg/day have been identified from the mouse inhalation (National Toxicology Programme, 1986) and oral cancer (National Cancer Institute, 1977; Weisburger, 1977) bioassays respectively. Evidence of hyaline droplet nephropathy was found in male rats following either inhalation or oral exposure, but the data indicate that this phenomenon, which is male rat-specific and hence not relevant to humans, only occurs at relatively high levels of exposure (1000 ppm, 6900 mg/m3and 1000 -1500 mg/kg/day) when relatively short exposure durations are employed. Congestion of the lungs was seen in mice following inhalation exposure at 100 ppm (690 mg/m3) for 2 years. One hundred ppm (690 mg/m3) is therefore also the LOAEC for this effect in the lungs.
Based on the available data, tetrachloroethylene does not need to be classified for repeated dose toxicity according to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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