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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
10 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):
1
Dose descriptor starting point:
NOAEL
Value:
6.67 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
23.35 mg/m³
Explanation for the modification of the dose descriptor starting point:

Performance of the inhalation study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.2).

A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1
Justification:
Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
AF for other interspecies differences:
1
Justification:
Not applicable, since human data are available.
AF for intraspecies differences:
1
Justification:
Not applicable, please refer to "Additional information - worker"
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
66.7 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
Dose descriptor starting point:
NOAEL
Value:
6.67 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
66.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Performance of the dermal study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.3).

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, since human data are available.
AF for other interspecies differences:
1
Justification:
Not applicable, since human data are available
AF for intraspecies differences:
1
Justification:
Not applicable, please refer to "Additional information - worker"
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:

DNEL derivation for each of the relevant endpoints was based on the most conservative dose descriptors obtained. Assessment factors were assigned accordingly. Thus, the DNELs represent worst-case scenarios. 

Worker – Hazard via inhalation route

Step 1: Selection of the relevant dose descriptor (starting point):

For risk characterisation an inhalation NOAEC was derived by route to route extrapolation (ECHA CSA R.8, 2012). The oral NOAEL long-term (human) of 6.67 mg Li3PO4/kg bw/day was considered as key value for the chemical safety assessment and therefore, most relevant starting point.

Step 2: Modification into a correct starting point:

For worker a NOEC long-term, inhalation was calculated assuming 70 kg per person (70 kg/person x 6.67 mg Li3PO4/kg bw/day = 467 mg/person/day), 8h light activity (10 m³ breathing volume), 50 % absorption via oral routes and 100 % absorption via inhalatory routes.

 

NOAEC (worker) inhalation = 467 mg Li3PO4/person/day * (1 / 10m³/person/day(8h)) * (50% Abs. / 100 / abs.) = 23.35 mg Li3PO4/m³

Step 3: Use of assessment factors: 1

An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations (being acceptable to humans, which are physically fit, but also being applicable to all sub-populations, in conclusion being applicable to worker and general population). 

The resulting worker DNEL long-term inhalation is 23.35 mg Li3PO4/m³/day (23.35 mg/m³/day : 1 (AFs)).

According to ECHA guidance document CSA R.8, 2012, for dust as in case with lithium phosphate, the general dust limit should be applied if the derived DNEL for inhalation is above the general dust limit (10 mg/m³). The calculated DNEL long-term inhalation for lithium phosphate was determined to be 23.35 mg/m³, the DNEL considered for risk characterisation is the general dust limit of 10 mg/m³.

 

Worker – Hazard via dermal route

Step 1: Selection of the relevant dose descriptor (starting point):

For risk characterisation a dermal NOAEL was derived by route to route extrapolation. The oral NOAEL of 6.67 mg Li3PO4/kg bw/day, was considered as key value for the chemical safety assessment and therefore, most relevant starting point.

 

Step 2: Modification into a correct starting point: 

The NOAEL long-term dermal of 66.7 mg Li3PO4/kg bw/day was calculated from the NOAEL long-term oral of 6.67 mg Li3PO4/kg bw/day considering a conservative 10 % absorption through the skin (ECHA document R.7C, 2014, 7.12)

 

NOAEL (Li3PO4) long-term dermal = 6.67 mg/kg bw/day x 100%: 10% = 66.7 mg Li3PO4/kg bw/day

Step 3: Use of assessment factors: 1

An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from very reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations (being acceptable to humans, which are physically fit but also being applicable to all sub-populations) and therefore applicable for worker and general population.

The resulting worker DNEL long-term dermal is 66.7 mg Li3PO4/kg bw/day (66.7 mg/kg bw/day: 1 (AFs) = 66.7 mg Li3PO4/kg bw/day)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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):
1
Dose descriptor starting point:
NOAEL
Value:
6.67 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
10.01 mg/m³
Explanation for the modification of the dose descriptor starting point:

Performance of the inhalation study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.2). A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, since human data are available
AF for other interspecies differences:
1
Justification:
Not applicable, since human data are available
AF for intraspecies differences:
1
Justification:
Not applicable, please refer to "Additional information - general population"
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
DNEL (Derived No Effect Level)
Value:
66.7 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
Dose descriptor starting point:
NOAEL
Value:
6.67 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
66.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Performance of the dermal study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.3).

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, since human data are available.
AF for other interspecies differences:
1
Justification:
Not applicable, since human data are available.
AF for intraspecies differences:
1
Justification:
Not applicable, please refer to "Additional information - general population"
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
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:
6.67 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
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation required.
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation factor is needed since a chronic toxicity study is available.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, since human data are available.
AF for other interspecies differences:
1
Justification:
Not applicable, since human data are available.
AF for intraspecies differences:
1
Justification:
Not applicable, please refer to "Additional information - general population"
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20.01 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
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Gerneral:

DNEL derivation for each of the relevant endpoints was based on the most conservative dose descriptors obtained. Assessment factors were assigned accordingly. Thus, the DNELs represent worst-case scenarios. 

General population – Hazard via inhalation route

Step 1: Selection of the relevant dose descriptor (starting point):

For risk characterisation an inhalation NOAEC was derived by route to route extrapolation (ECHA CSR R.8, 2012). The oral NOAEL long-term (human) of 6.67 mg Li3PO4/kg bw/day was considered as key value for the chemical safety assessment and therefore, most relevant starting point.

Step 2: Modification into a correct starting point:

For general population a NOEC long-term, inhalation was calculated assuming 60 kg per person (60 kg/person x 6.67 mg Li3PO4/kg bw/day = 400 mg/person/day), 50 % absorption via oral routes and 100 % absorption via inhalatory routes and a daily exposure period of 24 hours (corresponding to breathing volume of 20 m³/day).

 

NOAEC (general population) inhalation = 400 mg Li3PO4/person/day * (1 / 20 m³/person/day(24h)) * (50 % Abs./ 100 % Abs.)= 10.01 mg Li3PO4/m³

Step 3: Use of assessment factors: 1

An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations (being acceptable to humans, which are physically fit but also being applicable to all sub-populations), being applicable for general population.

The resulting general population DNEL long-term inhalation is 10.01 mg Li3PO4/m³/day (10.01 mg/m³/day : 1 (AFs)).

According to ECHA guidance document CSA R.8, 2012, for dust as in case with lithium phosphate, the general dust limit should be applied if the derived DNEL for inhalation is above the general dust limit (10 mg/m³). The calculated DNEL long-term inhalation for lithium phosphate was determined to be 23.35 mg/m³, the DNEL considered for risk characterisation is the general dust limit of 10 mg/m³.

 

General population – Hazard via dermal route

Step 1: Selection of the relevant dose descriptor (starting point):

For risk characterisation a dermal NOAEL was derived by route to route extrapolation. The oral NOAEL of 6.67 mg Li3PO4/kg bw/day, was considered as key value for the chemical safety assessment and therefore, most relevant starting point.

 

Step 2: Modification into a correct starting point: 

The NOAEL long-term dermal of 66.7 mg Li3PO4/kg bw/day was calculated from the NOAEL long-term oral of 6.67 mg Li3PO4/kg bw/day considering a conservative 10 % absorption through the skin (ECHA document R.7C, 2014, 7.12)

NOAEL (Li3PO4) long-term dermal = 6.67 mg/kg bw/day x 100%: 10% = 66.7 mg Li3PO4/kg bw/day

Step 3: Use of assessment factors: 1

An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from very reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations being also acceptable to general population.

The resulting general population DNEL long-term dermal is 66.7 mg Li3PO4/kg bw/day (66.7 mg/kg bw/day: 1 (AFs) = 66.7 mg Li3PO4/kg bw/day)

 

General population - Hazard via oral route

Step 1: Selection of the relevant dose descriptor (starting point):

The toxicological relevant component of lithium phosphate is lithium. Thus, the NOAEL long-term oral was calculated to be 6.67 mg Li3PO4/kg bw/day, based on lithium NOAEL long-term oral of 1.2 mg Li/kg bw/day (obtained from human data on long-term (chronic) treatment of bipolar disorder with lithium carbonate, see IUCLID section 7.5).

Step 2: Modification into a correct starting point: 

Not required.

Step 3: Use of assessment factors: 1

An AF for exposure duration was not applicable as data available covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations being applicable to general population.

The resulting DNEL general population long-term oral is 6.67 mg Li3PO4/kg bw/day (6.67 mg Li3PO4/kg bw/day : 1 (AFs)).