potassium titanium oxide (K2Ti6O13)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

experimental data made available by ECHA

Data source

Reference

Reference Type:

review article or handbook

Title:

ECHA robust summaries for 12056-51-8

Author:

ECHA

Year:

2019

Bibliographic source:

ECHA robust summaries for 12056-51-8, ECHA,2019

Materials and methods

Objective of study:

other: Assessment of toxicokinetic behaviour

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Assessment of toxicological behavior

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-240-0

EC Name:

-

Cas Number:

12056-51-8

Molecular formula:

K2Ti6O13

IUPAC Name:

Potassium hexatitanate

Test material form:

solid: fibres

Details on test material:

Name of the test chemical: Potassium hexatitanate
Molecular formula: K2Ti6O13
Molecular Weight: 573 g/mol
Substance Type: inorganic
Physical State: Solid

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Acute and sub-chronic inhalation studies and an acute oral toxicity showed no evidence of systemic toxicity. The effects seen in the inhalation studies were attributable to local effects in the lung and upper respiratory tract. Although the molecular weight does not preclude absorption, the substance has very low solubility in water and organic solvents. In view of this low solubility and the toxicity
study results, it is unlikely that any significant systemic absorption of this substance would occur, although transport of sufficently small fibres, by phagocytic cells, into the
lymphatic circulation is a possibility.

Details on distribution in tissues:

Since it is unlikely that any significant absorption could occur, discussion of distribution, metabolism and excretion is largely irrelevant for this inorganic substance. Fibres entering the lymphatic system would be unlikely to dissolve and become bioavailable due to the very low solubility. These factors may, however, result in biopersistence of fibres deposited in the respiratory tract.

Details on excretion:

Since it is unlikely that any significant absorption could occur, discussion of distribution, metabolism and excretion is largely irrelevant for this inorganic substance. Fibres entering the lymphatic system would be unlikely to dissolve and become bioavailable due to the very low solubility. These factors may, however, result in biopersistence of fibres deposited in the respiratory tract.

Any other information on results incl. tables

The test chemical is majorly available in the form of fibre. Its fibrous nature indicates that inhalation exposure would be possible and this is the most relevent route of exposure. The substance is stable so exposure to degradents would not be expected.

Applicant's summary and conclusion

Conclusions:

The test chemical is majorly available in the form of fibre. Its fibrous nature indicates that inhalation exposure would be possible and this is the most relevent route of exposure. The substance is stable so exposure to degradents would not be expected.

Executive summary:

Absorption:

Acute and sub-chronic inhalation studies and an acute oral toxicity showed no evidence of systemic toxicity. The effects seen in the inhalation studies were attributable to local effects in the lung and upper respiratory tract. Although the molecular weight does not preclude absorption, the substance has very low solubility in water and organic  solvents. In view of this low solubility and the toxicity study results, it is unlikely that any significant systemic absorption of this substance would occur, although transport of sufficently small fibres, by phagocytic cells, into the lymphatic circulation is a possibility.

Distribution, Metabolism,Excretion

Since it is unlikely that any significant absorption could occur, discussion of distribution, metabolism and excretion is largely irrelevant for this inorganic substance. Fibres entering the lymphatic system would be unlikely to dissolve and become bioavailable due to the very low solubility. These factors may, however, result in biopersistence of fibres deposited in the respiratory tract.