Registration Dossier

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.