Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Expert review and assessment
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Not assignable as the result is from expert assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Objective of study:
other: Basic toxicokinetic assessment to support REACH registration
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Expert review of available data.
GLP compliance:
no

Test material

1
Reference substance name:
Reaction products of monoethanolamine and boric acid (1:1)
EC Number:
701-025-6
Cas Number:
94095-04-2
Molecular formula:
C2H7NO.BH3O3
IUPAC Name:
Reaction products of monoethanolamine and boric acid (1:1)
Test material form:
liquid
Details on test material:
Appearance: Clear colourless liquid
Purity/Composition: UVCB
Test item storage: At room temperature protected from light
Stable under storage conditions until: 31 March 2018 (expiry date)

Results and discussion

Any other information on results incl. tables

No toxicokinetic (absorption, metabolism, distribution, elimination) data is available for MEA-Polyborate. Available data is primarily physico-chemical properties that influence the absorption and distribution of the substance in the body. Both 1:1 and 1:3 mole ratios of MEA to boric acid are infinitely soluble in water with log Pow of -0.9 for the polyborate moiety by ICP-MS and log Pow of -2.5 for the organic moiety by LC-MS. The log P values indicate that both ratios of MEA-Polyborate will likely be 100% absorbed in the gastrointestinal track, primarily found in the blood serum and excreted primarily via the kidneys in the urine. The log P values also indicate that both ratios of MEA-Polyborate is poorly absorbed through the skin with dermal absorption rates similar to monoethanolamine. No data is available on the metabolism of MEA-Polyborate.

Applicant's summary and conclusion

Conclusions:
No toxicokinetic (absorption, metabolism, distribution, elimination) data is available for MEA-Polyborate. Available data is primarily physico-chemical properties that influence the absorption and distribution of the substance in the body. Both 1:1 and 1:3 mole ratios of MEA to boric acid are infinitely soluble in water with log Pow of -0.9 for the polyborate moiety by ICP-MS and log Pow of -2.5 for the organic moiety by LC-MS. The log P values indicate that both ratios of MEA-Polyborate will likely be 100% absorbed in the gastrointestinal track, primarily found in the blood serum and excreted primarily via the kidneys in the urine. The log P values also indicate that both ratios of MEA-Polyborate is poorly absorbed through the skin with dermal absorption rates similar to monoethanolamine. No data is available on the metabolism of MEA-Polyborate.