Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.98 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:
322.88 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
249.1 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the absence of an 8 h standard respiratory volume for dogs, route-to-route extrapolation is conducted in analogy to ECHA Guidance document R.8, Example R. 8-2 Workers by applying the following equation: corrNOAEC(worker, 8 h) = ([corrNOAEL(target)]*[worker bw])/([allometric factor dog]*[respiratory volume, worker, 8 h]). Hence, corrNOAEC(worker, 8 h) = ([99.64 mg/kg bw/day]*[70 kg])/([1.4]*[10 m³]) = 498.2 mg/m³. Further, it is assumed that the oral absorption rate is 50% of that of the inhalation absorption. Therefore corrNOAEC(worker, 8 h) = (498.4 mg/m³)*0.5 =249.1 mg/m³.

AF for dose response relationship:
1
Justification:
DNEL is based on NOAEL
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:
Allometric scaling not required since already considered in route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default AF for remaining differences
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
2
Justification:
DNEL is based on read-across from a structural analogue
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
no hazard identified
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 Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.67 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):
100
Dose descriptor starting point:
NOAEC
Value:
322.88 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
267 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the absence of an 8 h standard respiratory volume for dogs, route-to-route extrapolation is conducted in analogy to ECHA Guidance document R.8, Example R. 8-1 General public by applying the following equation: corrNOAEC(consumer, 24 h) = ([corrNOAEL(AlH2P3O10)]*[consumer bw])/([allometric factor dog]*[respiratory volume, consumer, 24 h]). Hence, corrNOAEC(consumer, 24 h) = ([249.2 mg/kg bw/day]*[60 kg])/([1.4]*[20 m³]) = 534 mg/m³. Further, it is assumed that the oral absorption rate is 50% of that of the inhalation absorption. Therefore corrNOAEC(consumer, 24 h) = (534 mg/m³)*0.5 = 267 mg/m³.

AF for dose response relationship:
1
Justification:
DNEL is based on an NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day oral study
AF for interspecies differences (allometric scaling):
1
Justification:
Not required, since already considered in route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population
AF for the quality of the whole database:
2
Justification:
DNEL based on read-across from a structural analogue
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
no hazard identified
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:
0.71 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):
140
Modified dose descriptor starting point:
NOAEL
Value:
99.64 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation required.

DNEL derivation is based on a (90-day) subchronic oral NOAEL of 322.88 mg/kg bw/day from a study conducted in beagle dogs with the test substance Phosphoric acid, aluminium sodium salt (15:3:8), having the molecular formula Na15Al3(PO4)8. Prior to route-to-route extrapolation, corrections for differences in molecular weight and stoichiometry need to be performed. The corrected NOAEL is calculated as follows: corrNOAEL(target substance) = [NOAEL(source substance)]*(No. of Al atoms in source substance)*[Molecular weight(target substance)/Molecular weight(source substance)]. Hence, corrected NOAEL= [322.88 mg/kg bw/day]*(3)*[(121.95 g/mol)/(1185.56 g/mol)] = 99.64 mg/kg bw/day

AF for dose response relationship:
1
Justification:
DNEL is based on an NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day oral study
AF for interspecies differences (allometric scaling):
1.4
Justification:
DNEL is based on a study conducted in dogs
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for remaining differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for the general population
AF for the quality of the whole database:
2
Justification:
DNEL based on read-across from a structural analogue
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population