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EC number: 480-340-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
NOEL = 0.007 mg/kg bw-day (perchlorate)
Additional information
The effect of perchlorate to humans was evaluated. Since no data on humans are available for the substance, the data on the dissociation substance (perchlorate) are used for the assessment of the effect on humans.
The dose response in humans for perchlorate inhibition of thyroidal iodide uptake and any short-term effects on thyroid hormones was evaluated in a volunteer human study. For this reason, 37 male and female volunteers were exposed to the substance in drinking water at 0.007, 0.02, 0.1, or 0.5 mg/kg-day for 14 days. In 24 subjects 8 - and 24 -hr measurements of thyroidal123I uptake (RAIU) were performed before exposure, on exposure days 2 (E2) and 14 (E14), and 15 days postexposure (P15). In another 13 subjects both E2 studies and the 8-hr P15 study were omitted.
A strong correlation between the 8- and 24-hr RAIU over all dose groups and measurement days was observed. No difference between E2 and E14 in the inhibition of RAIU produced by a given perchlorate dose was found nor any sex difference. On both E2 and E14, the dose response was a negative linear function of the logarithm of dose. Given default body weight and exposure assumptions, these doses would be ingested by an adult if the drinking-water supply contained perchlorate at concentrations of approximately 180 and 220 μg/l (ppb), respectively. On P15, RAIU was significantly indistinguishable from baseline indicating complete recovery from the inhibitory effect of the substance. Serum levels of thyroxine (total and free), triiodothyronine, and thyrotropin in blood sampled 16 times throughout the study were in the normal range for all subjects besides a woman that had abnormally TSH during the screening visit and E14. Only the 0.5 mg/kg-day dose group showed any effect on serum hormones: a slight downward trend in thyrotropin levels in morning blood draws during perchlorate exposure, with recovery by P15. Serum chemistry and hematology results were within the normal limits throughtout the study.
The lowest dose producing no statistically significant inhibition of uptake was 0.007 mg/kg-day. Thus, 0.007 mg/kg-day (7 μg/kg-day) was a NOEL for inhibition of RAIU. A more refined estimate of the true no-effect level (NEL) was estimated based on the dose response for inhibition of the 8- and 24-hr RAIU on E14 in all subjects; it was found to be 5.2 and 6.4 μg/kg-day, respectively.
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