Registration Dossier
Registration Dossier
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EC number: 237-224-5 | CAS number: 13701-64-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Absorption:
It is widely known that simple borate salts are readily absorbed via oral and inhalation routes of exposure, while dermal absorption over intact skin is considered very low (<0.5 %) in humans and experimental animals (SCCS, 2010).
Distribution:
Absorbed boron is distributed evenly and rapidly throughout the body and can be found in blood plasma, tissues and organs. Similar boron levels have been reported in soft tissues and blood plasma of both humans and experimental animals, while boron concentrations are observed higher in bone and lower in adipose tissues (HERA, 2005).
Metabolism:
It is widely accepted that prior to absorption in aqueous solutions at physiological pH and low concentrations that simple borate salts are rapidly hydrolysed to form undissociated boric acid as the dominant species. It is not expected that boric acid will be metabolised further, due to the strong boron-oxygen bonds (523 kJ/mol) (EMA, 2017).
Excretion:
Borate compounds are predominantly eliminated in urine as boric acid with a half-life of <24 hours in both humans and experimental animal (EMA, 2017).
References:
EMA (2017) Boric acid and borate used as excipients. Report published in support of the 'Questions and answers on boric acid and borates used as excipients in medicinal products for human use' (EMA/CHMP/619104/2013). European Medicines Agency.
HERA (2005) Substance: Boric Acid (CAS No 10043-35-3). Human and Environmental Risk Assessment on ingredients of Household Cleaning Products.
SCCS (2010) Opinion on boron compounds. Scientific Committee on Consumer Safety. 22 June, 2012. SCCS /1249/09. 1-28.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 0.5
- Absorption rate - inhalation (%):
- 100
Additional information
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