Registration Dossier
Registration Dossier
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EC number: 948-963-4 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.34 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 104 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 183.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point was corrected according to Figure R.8-3 in chapter R.8 in the ECHA guidance document (version 2.1, November 2012). NOAEL (oral, rat) = 104 mg/kg bw/day => NOAEC(corrected, inhalation) = NOAEL(oral, rat) x 1/(0.38 m3/kg bw/day) x 6.7 m3/10 m3 = 183.4 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on oral 90-day study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route; any metabolism of inorganic barium substances can be excluded.
Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1” instead of using the default factor of 4.183,4/15 - AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- AF for workers
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- By inhalation
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 104 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 104 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In an acute dermal toxicity study with Wistar rats the LD50 was determined to be > 2000 mg/kg for Barium titanate. No signs of systemic toxicity were observed, indicating primarily no dermal toxicity as a result of poor absorption. Overall, due to the experimental low dermal toxicity, the low water solubility, the high molecular weight (>100) and the fact that the substance is not irritating to skin implies that dermal uptake of BCZT in humans is considered as very low. Therefore, the starting point was corrected according to the low absorption through skin.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on oral 90-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- test animal: rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- AF for workers
- AF for the quality of the whole database:
- 1
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
Since only oral repeated dose studies from the analogous test substance barium chloride dihydrate are available, route-to-route extrapolation might be considered necessary for the long-term systemic dermal and inhalation DNELs.
For inhalation absorption 100 % absorption is assumed for oral absorption 20% and for dermal absorption 1% absorption is assumed, based on a toxicokinetic assessment.
The DNELs for human exposure are derived according to the ECHA Guidance on information requirements and chemical safety assessment (Chapter R.8: Characterisation of dose-/concentration-response for human health, Version: 2, December 2010).
Acute DNELs for local and systemic effects
Due to its very low systemic toxicity acute DNELs for barium titanium trioxide are not considered applicable.
The substance is not classified for local effects and therefore DNELs for local effects were not derived.
Long-term DNELs for local effects
The substance is not classified for local effects and therefore DNELs for local effects were not derived.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.81 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 104 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 90.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point was corrected according to Figure R.8-3 in chapter R.8 in the ECHA guidance document (version 2.1, November 2012). NOAEL (oral, rat) = 104 mg/kg bw/day => NOAEC(corrected, inhalation) = NOAEL(oral, rat) x 1/(1.15 m3/kg bw/day) = 90.4 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a 90-day study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- AF for general population
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- By inhalation
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:
- DNEL (Derived No Effect Level)
- Value:
- 52 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 104 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In an acute dermal toxicity study with Wistar rats the LD50 was determined to be > 2000 mg/kg for Barium titanate. No signs of systemic toxicity were observed,indicating primarily no dermal toxicity as a result of poor absorption.Overall, due to the experimental low dermal toxicity, the low water solubility, the high molecular weight (>100) and the fact that the substance is not irritating to skin implies that dermal uptake of BCZT in humans is considered as very low. Therefore, the starting point was corrected according to the low absorption through skin.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a 90-day study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- test animal: rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- AF for general population
- AF for the quality of the whole database:
- 1
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.52 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 104 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 104 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a 90-day study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- test animal: rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- AF for general population
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Since only oral repeated dose studies are available, route-to-route extrapolation might be considered necessary for the long-term systemic dermal and inhalation DNELs.
For oral absorption 20% absorption, for inhalation absorption 100 % absorption and for dermal absorption 1 % absorption is assumed, based on a toxicokinetic assessment.
The DNELs for human exposure are derived according to the ECHA Guidance on information requirements and chemical safety assessment (Chapter R.8: Characterisation of dose-/concentration-response for human health, Version: 2, 2010).
Acute DNELs for local and systemic effects
Due to its very low systemic toxicity acute DNELs for barium titanium trioxide are not considered applicable.
The substance is not classified for local effects and therefore DNELs for local effects were not derived.
Long-term DNELs for local effects
The substance is not classified for local effects and therefore DNELs for local effects were not derived.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
