Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

health surveillance data
Type of information:
other: secondary source
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Summary of available information summairsed in the EU RAR

Data source

Reference Type:
review article or handbook
European Union Risk Assessment Report, hydrogen fluoride.
Bibliographic source:
European Union Risk Assessment Report, Volume 8, Institute for Health and Consumer Protection, European Chemicals Bureau.

Materials and methods

Study type:
biological effect monitoring
Principles of method if other than guideline:
Review of the effects of fluoride in exposed populations
GLP compliance:

Test material

Constituent 1
Reference substance name:
Reference substance 001
Details on test material:
Effects of fluoride in drinking water


Details on study design:
The EU RAR reviews the findings of a number of studies investigating the effects

Results and discussion

Any other information on results incl. tables

Severe skeletal fluorosis was reported in humans after prolonged intake of 15 mg/day (215 µg/kg bw/day in an adult weighing 70 kg) and above. In one case, exposure to drinking water containing 8 mg/l fluoride for 37 years resulted in fluoride-induced bone changes, but not in clinical signs. In a community exposed to 4 mg/l fluoride in the drinking water (estimated to be equivalent to 72 µg/kg bw/day) the relative risk for various bone fractures was 2.2 to 2.7 as compared to an "unexposed" control community which received 1 mg/l. However CEPA stated that exposure in the high fluoride community was probably underestimated, while the calcium concentration in the drinking water of this community was only about 25% of that in the control group.

Applicant's summary and conclusion