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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Following daily oral intake of 6.4 mg sodium tetrafluoroborate by a volunteer for a period of 14 days, a daily average of 100% was excreted in the urine and 1.6% in the feces. The fluoride content of the volunteer's food was not determined. Sodium fluoroborate is therefore well absorbed, but the fluoride which enters the body is not stored. The authors attributed this to slow hydrolysis of the tetrafluoroborate ion. In another study with 3 volunteers and a study duration of 7 to 38 weeks, there were indications that fluoride which was absorbed in the form of sodium tetrafluoroborate was stored in the body. The amount was <10% of that absorbed into the bloodstream. In addition, as a comparison and another read-across: LD50 (oral) for potassium tetrafluoroborate = 5855 mg/kg (rat).
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Name:
Ammonium tetrafluoroborate
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Ammonium tetrafluoroborate

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Administration / exposure

Details on oral exposure:
Following daily oral intake of 6.4 mg sodium tetrafluoroborate by a volunteer for a period of 14 days, a daily average of 100% was excreted in the urine and 1.6% in the feces. The fluoride content of the volunteer's food was not determined. Sodium fluoroborate is therefore well absorbed, but the fluoride which enters the body is not stored. The authors attributed this to slow hydrolysis of the tetrafluoroborate ion. In another study with 3 volunteers and a study duration of 7 to 38 weeks, there were indications that fluoride which was absorbed in the form of sodium tetrafluoroborate was stored in the body. The amount was <10% of that absorbed into the bloodstream.

Results and discussion

Applicant's summary and conclusion