Lithium titanium oxide (Li4Ti5O12)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: Compilation and evaluation of available data.

Adequacy of study:

key study

Study period:

2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Compilation and evaluation of results.

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Objective of study:

bioaccessibility (or bioavailability)

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Toxicokinetic parameters such as uptake, distribution, metabolism and excretion form the essential toxicological profile of a substance. The assessment of the toxicokinetic properties of Lithium-Titanium-Oxide was based on the results obtained for the following toxicological end-points and physico-chemical data such as solubility.

Data used in this assessment
• Acute oral toxicity: LD50 >2000 mg/kg in rats
• Acute inhalation toxicity: LC50 > 5 mg/L in rats
• Skin irritation/corrosivity: Non irritant
• Eye irritation: slight effects
• Skin sensitisation: Negative in M&K assay
• Subacute (28-day plus reprotoxicity) oral toxicity: NOEL = 1000 mg/kg bw
• Bacterial reverse mutation test: Negative
• Mammalian cell in vitro genotoxicity: Negative
• Toxicity to daphnia: EC50 > solubility
• Toxicity to fish: LC50 > solubility
• Toxicity to Activated Sludge: NOEC = 1000 mg/L

Physico-chemical properties
Molecular weight: 459.0935 g/mol
Water solubility : <0.25 mg/L (low)
Melting point: >1000 °C
pH: ~10.4 at 1 g/L
Vapour pressure: No data, expected to be extremely low
Surface tension: No activity expected (based on chemical structure and lack of foaming)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)

EC Number:

619-916-2

Cas Number:

12031-95-7

Molecular formula:

Li4Ti5O12

IUPAC Name:

tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Radiolabelling:

no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

ABSORPTION by the dermal route:
Examination of the data of the dermal irritation and skin sensitisation studies gave no indication of there being any evidence for skin penetration of the test item. The inorganic particulate nature of the chemical with very low expected solubility and surface tension in biological fluids or membranes, based on physicochemical data, confirms that no significant skin penetration is anticipated for this substance.
ABSORPTION by the oral route:
Examination of the data of the acute and repeat dose oral studies gave no indication of there being any evidence for oral bioavailability by the oral route for the test item. The inorganic particulate nature of the chemical with very low expected solubility in intestinal or biological fluids, or in membranes, based on physicochemical data, suggests a low or very low bioavailability. The lack of any systemic effects even at a maximum daily rate of 1000 mg/kg/day means that either there was no absorption through the intestine, or the absorption was so low that no biological effects could be observed.
ABSORPTION by the inhalation route:
Examination of the data of the inhalation study gave no indication of there being any evidence for bioavailability of the test item. The inorganic particulate nature of the chemical with very low expected volatility, and very low solubility in biological fluids or membranes, based on physicochemical data, suggests low or very low bioavailability by inhalation. The results of this study were consistent with a non-soluble, non-toxic inert dust.

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:

Examination of the data from the local irritation/sensitisation assays, bacterial reverse mutation and mammalian cell genotoxicity assays, and from the toxicity assays on daphnia, fish and activated sludge; there was no evidence of any toxicity or significant biological effects of the test item in these assay systems.

Any other information on results incl. tables

The studies performed and the available physicochemical data are consistent with an inorganic molecule with a very low bioavailability with no indication or evidence for potential for bioaccumulation.

The test item supplied was of a small particle size with a high surface area to mass ratio (~3 m2/g) so the lack of biological effects or bioavailability was not due to lack of intimate contact with the biological systems.

There were no studies that showed any bioavailability or bioaccumulation, in that there was no toxicity or evidence for absorption seen in any of the studies performed on biological systems.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results

Executive summary:

The studies performed and the available physicochemical data are consistent with an inorganic molecule with a very low bioavailability with no indication or evidence for potential for bioaccumulation.

The test item supplied was of a small particle size with a high surface area to mass ratio (~3 m2/g) so the lack of biological effects or bioavailability was not due to lack of intimate contact with the biological systems.

There were no studies that showed any bioavailability or bioaccumulation, in that there was no toxicity or evidence for absorption seen in any of the studies performed on biological systems.