Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
108.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Please refer to Eurometaux publication which is attached to this dossier.
Overall assessment factor (AF):
6
Dose descriptor starting point:
NOAEL
Value:
741 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
653.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNELs for the long-term exposure are derived from the no observed effect level obtained in an oral repeated dose toxicity study with Lanthanum carbonate octahydrate. Since no substance-related effects were noted, a NOAEL of 974 mg/kg bw/day was estimated after treatment for 90 days corresponding to 741 mg/kg bw/day Lanthanum carbonate (Reißmüller, 2006). For calculation of the DNEL for long-term inhalative systemic effects, an allometric scaling has to be applied to take into account route-to-route extrapolation as well as the interspecies difference between rat and human. Therefore, the no observed effect level has to be corrected by 1/0.38 and 6.7/10 regarding respiratory volume and frequency. Further a difault factor of 2 is applied for oral-to-inhalation extrapolation, assuming a worst case scenario according to R 8.4.2 (oral bioavailability < 0.002). Thus, the corrected starting point for workers was 653.3 mg/m³ bw/day for inhalation exposure.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a sub-chronic study in rats over a time period of 90 days.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not applicable for inhalation route.
AF for other interspecies differences:
1
Justification:
No additional factor for chemical-specific remaining uncertainties is applied.
AF for intraspecies differences:
3
Justification:
The appropriateness of the applied assessment factors is justified in the attached document and under additional information on workers.
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
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:
123.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Please refer to Eurometaux publication which is attached to this dossier.
Overall assessment factor (AF):
6
Dose descriptor starting point:
NOAEL
Value:
741 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNELs for the long-term exposure are derived from the no observed effect level obtained in an oral repeated dose toxicity study with Lanthanum carbonate octahydrate. Since no substance-related effects were noted, a NOAEL of 974 mg/kg bw/day was estimated after treatment for 90 days corresponding to 741 mg/kg bw/day Lanthanum carbonate (Reißmüller, 2006). For the derivation of the sytemic dermal DNEL a correction of the starting point is not required. Subsequently, following assessment factors are taken into account for the DNEL calculation: intraspecies differences (3), exposure duration (2). As a consequence, the resulting DNEL for long-term dermal systemic effects of Lanthanum carbonate is 123.5 mg/kg bw/day for workers.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a sub-chronic study in rats over a time period of 90 days.
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor for interspecies differences considered.
AF for other interspecies differences:
1
Justification:
No assessment factor for interspecies differences considered.
AF for intraspecies differences:
3
Justification:
The appropriateness of the applied assessment factors is justified in the attached document and under additional information on workers.
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Lanthanum carbonate, the salt formed by lanthanum(III) cations and carbonate anions, is used in industry in lanthanum chemistry e.g. as a catalyst.

Therefore, dermal and inhalative intakes are the possible exposure routes for worker.

Together with the fact that no substance-related local effects could be determined, only the DNEL for long-term systemic effects are derived.

 

The DNELs for the long-term exposure are derived from the no observed effect level obtained in an oral repeated dose toxicity study with Lanthanum carbonate octahydrate. Since no substance-related effects were noted, a NOAEL of 974 mg/kg bw/day was estimated after treatment for 90 days corresponding to 741 mg/kg bw/day Lanthanum carbonate (Reißmüller, 2006).

The assessment factors applied were chosen on the basis of a recent publication by Eurometaux which is attached to this dossier.

 

For calculation of the DNEL for long-term inhalative systemic effects, an allometric scaling has to be applied to take into account route-to-route extrapolation as well as the interspecies difference between rat and human. Therefore, the no observed effect level has to be corrected by 1/0.38 and 6.7/10 regarding respiratory volume and frequency. Thus, the corrected starting point for workers was 653.3 mg/m³ bw/day for inhalation exposure.

Subsequently, the assessment factors are listed, which have to be taken into account for the calculation of the inhalation DNEL: intraspecies differences (3), exposure duration (2).

Thus, the resulting DNEL for long-term inhalative systemic effects of Lanthanum carbonate is 108.9 mg/m³ for workers.

For the derivation of the sytemic dermal DNEL a correction of the starting point is not required.

Subsequently, following assessment factors are taken into account for the DNEL calculation: intraspecies differences (3), exposure duration (2).

As a consequence, the resulting DNEL for long-term dermal systemic effects of Lanthanum carbonate is 123.5 mg/kg bw/day for workers.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

Lanthanum carbonate is used in industrial settings only. The substance is used as an intermediate in catalysts. In some instances substance or a derivative will be incorporated into the matrix of the catalyst produced. The substance wil not be part of the final product of the catalysed reaction. Therefore, DNELs for consumers or the general population are not relevant.