Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: expert statement

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Assessment of toxicokinetic behaviour based on toxicity data and on physico-chemical properties.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Objective of study:

absorption

distribution

excretion

metabolism

Test guideline

Qualifier:

according to guideline

Guideline:

other: Technical Guidance Document on Risk Assessment, Part I, 2003

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

other: micro-granulated

Radiolabelling:

other: not applicable

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

limited absorption into the body is expected

Details on distribution in tissues:

if absorbed, the substance is expected to be distributed into intravasal compartment

Details on excretion:

will beexcreted predominantly unchanged via the bile and the urine

Any other information on results incl. tables

Please see attached full version of toxicokinetic assessment (in section 13).

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
Fe(3Na)EDDHSA has low absorption potential via all exposure routes. If absorbed, it is expected to be distributed predominantly in intravasal compartment. The substance is not expected to be metabolised and will be excreted mainly unchanged via the faeces or via the urine.

Executive summary:

Fe(3Na)EDDHSA is expected to be poorly absorbed after oral exposure, based on its water solubility and its insolubility in n-octanol. Concerning the absorption after exposure via inhalation, as the chemical is considered to have a low vapour pressure, is highly hydrophilic, insoluble in n-octanol, and has a rather high molecular weight, it is clear, that the substance is poorly available for inhalation and will not be absorbed significantly. In addition this is supported by the particle size distribution of Fe(3Na)EDDHSA which shows that only a minor amount will be available as the respirable fraction. Fe(3Na)EDDHSA is also not expected to be absorbed following dermal exposure into the stratum corneum and into the epidermis, due to its molecular weight and its high water solubility. Concerning its distribution in the body Fe(3Na)EDDHSA is expected to be distributed mainly in the intravasal compartment, due to its high water solubility. The substance does not indicate a significant potential for accumulation. Fe(3Na)EDDHSA is expected not to be significantly metabolised but to be eliminated unchanged via urine and bile.