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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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