Lithium dihydrogen 5-sulphonatoisophthalate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Remarks:

Expert Opinion

Type of information:

other: Expert Opinion

Adequacy of study:

supporting study

Study period:

7 August 2020

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Expert opinion based on sound toxicological principles.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Objective of study:

other: Basic toxicokinetics (expert opinon)

Principles of method if other than guideline:

No guideline followed

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lithium dihydrogen 5-sulphonatoisophthalate

EC Number:

256-275-4

EC Name:

Lithium dihydrogen 5-sulphonatoisophthalate

Cas Number:

46728-75-0

Molecular formula:

C8H6O7S.Li

IUPAC Name:

lithium dihydrogen 5-sulphonatoisophthalate

Test material form:

solid: particulate/powder

Details on test material:

- Moisture content: 6.5%
- Colour: Off-white

Radiolabelling:

no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Oral Bioavailability: The subject material is a water soluble and ionizable material with an estimated octanol/water partition coefficient (log) of -3.2 and a moderate molecular weight (MW=252). Such a material should readily dissolve in the gastro-intestinal fluid. However, the presence of ionizable groups may somewhat reduce the absorption potential. Given some measured systemic effects in experimental animals following oral exposures, absorption from the gastrointestinal tract cannot be precluded.

Dermal Bioavailability: Compounds most readily absorbed through the relatively impervious stratum corneum skin layer are those of moderate lipophilicity and having both some water and fat solubility. The subject material is highly water soluble but is of a low lipophilicity, as evidenced by a low octanol/water partition coefficient. Such a material should not be readily absorbed through the skin.

Inhalation Bioavailability: Inhalation exposure could result in deposition of material in the upper nasopharyngeal region of the respiratory tract or, if particle size is small enough, in the alveolar region. In either case, due to its expected solublility in the mucous coating of the respiratory tract and potential subsequent oral exposure due to swallowing, the material should be considered to be bioavailable by the inhalation route.

Details on distribution in tissues:

Once absorbed, the material is not expected to accumulate or bioconcentrate in tissues.

Details on excretion:

The highly ionized nature of the material suggests rapid elimination primarily through the urine.

Applicant's summary and conclusion

Conclusions:

The substance is expected to be readily absorbed by the oral and inhalation routes where it would be readily ionized and excreted in the urine. No significant bioaccumulation is expected.

Executive summary:

The substance is expected to be readily absorbed by the oral and inhalation routes where it would be readily ionized and excreted in the urine. No significant bioaccumulation is expected.