Registration Dossier
Registration Dossier
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EC number: 619-916-2 | CAS number: 12031-95-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- It can be anticipated that no different toxic effects will be produced by the different routes of dosing, or more likely that no toxicity at all will be produced, because of the insolubility of the substance in water. This is endorsed by no observed toxicity in the acute oral and inhalation study, even at high doses.
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect was observed even at the highest used dose of 1000 mg/kg bw/d. No effect is expected as the substance is insoluble in water.
- AF for differences in duration of exposure:
- 5
- Justification:
- The available study of ca. 40 days exposure is between a subacute and a subchronic study type.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- according to ECETOC
- AF for other interspecies differences:
- 1
- Justification:
- according to ECETOC
- AF for intraspecies differences:
- 3
- Justification:
- according to ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline study with GLP
- AF for remaining uncertainties:
- 1
- Justification:
- No relevant uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 350 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: ECHA and ECETOC
- Overall assessment factor (AF):
- 36
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5 040 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Not relevant as no route to route extrapolation is performed.
- AF for dose response relationship:
- 3
- Justification:
- No adverse effects were noted in the acute toxicity study at 5040 mg/m³. AF for taking into account the not investigated endpoints in the acute toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to ECHA guidance.
- AF for other interspecies differences:
- 1
- Justification:
- According to ECETOC.
- AF for intraspecies differences:
- 3
- Justification:
- According to ECETOC.
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline study with GLP.
- AF for remaining uncertainties:
- 1
- Justification:
- No relevant uncertainties.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It can be anticipated that no different toxic effects will be produced by the different routes of dosing, or more likely that no toxicity at all will be produced, because of the insolubility of the substance in water.
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect was observed even at the highest used dose of 1000 mg/kg bw/d. No effect is expected as the substance is insoluble in water.
- AF for differences in duration of exposure:
- 5
- Justification:
- The available study of ca. 40 days exposure is between a subacute and a subchronic study type.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to ECETOC
- AF for other interspecies differences:
- 1
- Justification:
- According to ECETOC
- AF for intraspecies differences:
- 3
- Justification:
- According to ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline study with GLP
- AF for remaining uncertainties:
- 1
- Justification:
- No relevant uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Lithium titanium oxide is not relevant for the general population, only workers could be exposed.
Lithium titanium oxide is not classified as to local irritation and does not show toxic effect in the acute toxicity studies with oral and inhalation routes of administration and in a repeated dose toxicity study with oral application.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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