Registration Dossier
Registration Dossier
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EC number: 231-830-3 | CAS number: 7758-02-3
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
In a 12 week study in humans a significant increase in serum thyroxine and triiodothyronine was observed between the start and end of the study for the 9 mg(Br-)/kg bw/day dose group females but remained within normal limits at all concentrations. No changes were observed in measurements of hormones produces by the adrenals, the gonads and the pituitary gland.
Given the hormone changes observed, despite that fact that they are considered to remain within normal limits, a precautionary LOAEL of 9 mg(Br-)/kg bw/day has been determined. The NOAEL from this study is therefore 4 mg(Br-)/kg bw/day.
Additional information
The lowest LOAEL was obtained in a 12 week study in humans (Van Gelderen et al., 1993):
No findings of clinical effects relevant to the investigation were found, except for some incidences of nausea associated with bromide-capsule ingestion.Haematological, clinical chemistry and urine analysis parameters remained within normal limits for all dose groups.
A significant increase in serum thyroxine and triiodothyronine between the start and end in the study for the 9 mg(Br-)/kg bw/day dose group females but all concentrations remained within normal limits. No changes were observed in measurements of hormones produces by the adrenals, the gonads and the pituitary gland.
All neurophysiological findings were within normal limits.
Given the hormone changes observed, despite that fact that they are considered to remain within normal limits, a precautionary LOAEL of 9 mg(Br-)/kg bw/day has been determined. The NOAEL from this study is therefore 4 mg(Br-)/kg bw/day.
A lower NOAEL of 1 mg(Br-)/kg bw/day was found in a shorter (8 week) human volunteer study, however, only one dose was assessed in this study and no LOAEL was determined.
An additional 12 week in humans study concluded that the NOAEL is 9 mg(Br-)/kg bw/day. Given that a LOAEL has been determined at this dose the NOAEL was not used.
In summary:
LOAEL: 9 mg(Br-)/kg bw/day - hormone level alterations in females.
NOAEL: 4 mg(Br-)/kg bw/day.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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