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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.9 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
132 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 150 mg/kg/day x [1/0.38 x 50/100 x 6.7/10] = 132 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.3 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
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
132 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 150 mg/kg/day x [1/0.38 x 50/100 x 6.7/10] = 132 mg/m3
AF for dose response relationship:
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1

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:
0.5 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL: 150 mg/kg/day x [oral absorption 50% / dermal absorption 25%] = 300 mg/kg/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 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
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL: 150 mg/kg/day x [oral absorption 50% / dermal absorption 25%] = 150 mg/kg/day
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1

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

Justification for endpoint selection:

- Reproductive toxicity: effects on fertility (oral): The key study was conducted in compliance with GLP and in accordance with the OECD Guideline for the Testing of Chemicals Number 422 on the structural analogue cerium carbonate.

- Reproductive toxicity: effects on fertility (dermal): The data obtained from oral exposure is deemed sufficient to address this endpoint.

- Reproductive toxicity: effects on fertility (inhalation): The data obtained from oral exposure is deemed sufficient to address this endpoint.

- Reproductive toxicity: developmental toxicity (oral): The key study was conducted in compliance with GLP and in accordance with the OECD Guideline for the Testing of Chemicals Number 422 on the structural analogue cerium carbonate.

- Reproductive toxicity: developmental toxicity (dermal): The data obtained from oral exposure is deemed sufficient to address this endpoint.

- Reproductive toxicity: developmental toxicity (inhalation): The data obtained from oral exposure is deemed sufficient to address this endpoint.

Acute toxicity: the registered substance is not acutely toxic, as the acute dermal LD50 was determined to be greater than 2000 mg/L and the acute oral LD50 is greater than 1000 mg/kg (1000mg/kg bw/day was tested in a repeat dose toxicity study).

Skin and eye irritation/corrosion; skin sensitisation: The registered substance was not irritating to skin and did not show sensitising potential.

Repeat-dose toxicity: a fully compliant 28-d toxicity study is available on the structural analogue cerium cerbonate (Davies, R, 2008), performed according to OECD guideline 422. The study established a NOEL at 150 mg/kg/day, because treatment caused effects on the stomach in both sexes at 1000 mg/kg/day and at 450 mg/kg/day in males.

Reproductive and developmental toxicity: a fully compliant OECD 422 study is available on the structural analogue cerium cerbonate (Davies, R, 2008). The study established a NOEL for reproduction and developmental toxicity of 1000 mg/kg/day based on the absence of effects at the highest dose tested.

Oral and dermal absorption: 50%, 25%

Inhalation absorption: 100%

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
65.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 150 mg/kg/day x [1/1.15 x 50/100] = 65.2 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 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
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
65.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 150 mg/kg/day x [1/1.15 x 50/100] = 65.2 mg/m3
AF for dose response relationship:
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1

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:
0.25 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):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL: 150 mg/kg/day x [oral absorption 50% / dermal absorption 25%] = 300 mg/kg/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL: 150 mg/kg/day x [oral absorption 50% / dermal absorption 25%] = 300 mg/kg/day
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1

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:
0.13 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):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
1

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Justification for endpoint selection:

- Reproductive toxicity: effects on fertility (oral): The key study was conducted in compliance with GLP and in accordance with the OECD Guideline for the Testing of Chemicals Number 422 on the structural analogue cerium carbonate.

- Reproductive toxicity: effects on fertility (dermal): The data obtained from oral exposure is deemed sufficient to address this endpoint.

- Reproductive toxicity: effects on fertility (inhalation): The data obtained from oral exposure is deemed sufficient to address this endpoint.

- Reproductive toxicity: developmental toxicity (oral): The key study was conducted in compliance with GLP and in accordance with the OECD Guideline for the Testing of Chemicals Number 422 on the structural analogue cerium carbonate.

- Reproductive toxicity: developmental toxicity (dermal): The data obtained from oral exposure is deemed sufficient to address this endpoint.

- Reproductive toxicity: developmental toxicity (inhalation): The data obtained from oral exposure is deemed sufficient to address this endpoint.

Acute toxicity: the registered substance is not acutely toxic, as the acute dermal LD50 was determined to be greater than 2000 mg/L and the acute oral LD50 is greater than 1000 mg/kg (1000mg/kg bw/day was tested in a repeat dose toxicity study).

Skin and eye irritation/corrosion; skin sensitisation: The registered substance was not irritating to skin and did not show sensitising potential.

Repeat-dose toxicity: a fully compliant 28-d toxicity study is available on the structural analogue cerium cerbonate (Davies, R, 2008), performed according to OECD guideline 422. The study established a NOEL at 150 mg/kg/day, because treatment caused effects on the stomach in both sexes at 1000 mg/kg/day and at 450 mg/kg/day in males.

Reproductive and developmental toxicity: a fully compliant OECD 422 study is available on the structural analogue cerium cerbonate (Davies, R, 2008). The study established a NOEL for reproduction and developmental toxicity of 1000 mg/kg/day based on the absence of effects at the highest dose tested.

Oral and dermal absorption: 50%, 25%

Inhalation absorption: 100%