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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Description of key information

- Vaziri and Ovesiri, 2000 (not metabolised; rats);
- Hui et al., 1996 and Hartway et al. 1997  (percutaneous absorption in humans: 0.226 ± 0.125 %);
- Pahl and Culver, 2000 (excretion data of boron in humans: mainly excreted in the urine);
- Dourson et al., 1998: justification of data-specific assessment factors for toxicokinetics and toxicodynamic of boron;
- Dunlop 1981, Krutzen et al. 1992, Sturgiss et al. 1996. (GFR in sensitive population, justification for intraspecies AFs);
- Maier et al., 2014 (Data derived assessment factors for human variability in toxicokinetics and toxicodynamics are reported).

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

There is little difference between animals and humans in absorption, distribution, and metabolism. A difference in renal clearance is the major determinant in the differences between animals and humans, with the renal clearance in rats approximately 3 times faster than in humans.


 


Boric acid is not metabolised in either animals or humans, owing to the high energy level required (523 kJ/mol) to break the B - O bond (Emsley, 1989). Other inorganic borates convert to boric acid at physiological pH in the aqueous layer overlying the mucosal surfaces prior to absorption. Most of the simple inorganic borates exist predominantly as undissociated boric acid in dilute aqueous solution at physiological and environmental pH, leading to the conclusion that the main species in the plasma of mammals is un-dissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as un-dissociated boric acid under the same conditions. Additional support for this derives from studies in which more than 90 % of administered doses of inorganic borates are excreted in the urine as boric acid. Absorption of borates via the oral route is nearly 100 %. For the inhalation route also 100 % absorption is assumed as worst case scenario. Dermal absorption through intact skin is very low with a percent dose absorbed of 0.226 ± 0.125 in humans. Using the % dose absorbed plus standard deviation (SD) for boric acid, a dermal absorption for borates of 0.5 % (rounded from 0.45 %) can be assumed as a worse case estimate.


 


In the blood boric acid is the main species present and is not further metabolised. Boric acid is distributed rapidly and evenly through the body, with concentrations in bone 2 - 3 higher than in other tissues. Boric acid is excreted rapidly, with elimination half-lives of 1 h in the mouse, 3 h in the rat and < 27.8 h in humans, and has low potential for accumulation. Boric acid is mainly excreted in the urine.


 


Interspecies differences in toxicokinetics based on data for boron clearance rates in rats versus humans and intraspecies differences in human toxicokinetics based on data on human variability in glomerular filtration rates (GFR) are critical determinates in evaluating human toxicity of boric acid. GFR was identified as the primary determinant of boron clearance rates. A toxicokinetic adjustment factor for boron for human variability is based on the variability in GFR during pregnancy (Dunlop, 1981; Krutzén et al., 1992; Sturgiss et al., 1996) ensuring adequate coverage of the sensitive subpopulation of preeclamptic women (US. EPA 2004; Dourson et al. 1998; Maier et al. 2014).


 


Read Across


For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. As noted previously, only boric acid and the borate anion are present at environmentally and physiologically relevant concentrations. Read-across between the different boron compounds can be done on the basis of boron (B) equivalents. Conversion factors are given in the table below.






















































































Substance



Formula



Conversion factor for equivalent dose of B (multiply by)



 Boric acid



 H3BO3



 0.1748



 Boric Oxide



 B2O3



 0.311



 Disodium tetraborate anhydrous



 Na2B4O7



 0.2149



 Disodium tetraborate pentahydrate



 Na2B4O7∙5H2O



 0.1484



 Disodium tetraborate decahydrate



 Na2B4O7∙10H2O



 0.1134



 Disodium octaborate tetrahydrate



 Na2B8O13·4H2



 0.2096



 Sodium metaborate (anhydrous)



 NaBO2



 0.1643



 Sodium metaborate (dihydrate)



 NaBO2·2H2O



 0.1062



 Sodium metaborate (tetrahydrate)



 NaBO2·4H2O



 0.0784



 Sodium pentaborate (anhydrous)



 NaB5O8



 0.2636



 Sodium pentaborate (pentahydrate)



 NaB5O8∙5H2O



 0.1832



 Dipotassium tetraborate (anhydrous)



 K2B4O7



 0.185



 Dipotassium tetraborate (tetrahydrate)



 K2B4O7.4H2O



 0.1415



 Potassium pentaborate (anhydrous)



 KB5O8



 0.244



 Potassium pentaborate (tetrahydrate)



 KB5O8.4H2O



 0.1843



 


 Please also refer to the read-across statement attached to section 13.