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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.52 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
Modified dose descriptor starting point:
NOAEC
Value:
575.82 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(AlH2P3O10)]*[worker bw])/([allometric factor dog]*[respiratory volume, worker, 8 h]). Hence, corrNOAEC(worker, 8 h) = ([230.33 mg/kg bw/day]*[70 kg])/([1.4]*[10 m³]) = 1151.65 mg/m³. Further, it is assumed that the oral absorption rate is 50% of that of the inhalation absorption. Therefore corrNOAEC(worker, 8 h) = (1151.65 mg/m³)*0.5 = 575.82 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 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:
Remaining differences
AF for intraspecies differences:
5
Justification:
For workers
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
32.9 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):
70
Modified dose descriptor starting point:
NOAEL
Value:
2 303.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is conducted in accordance with ECHA Practical Guide 14, Table 2 by applying the following equation: Dermal NOAEL = (oral NOAEL)*( ABSoral/ABSdermal). Based on the inorganic (ionic) nature of the substance, its molecular weight of ca. 282 g/mol and very low solubility (0.34 mg/L), dermal absorption is considered to be lower than oral absorption. A default value of 10% dermal absorption is taken as a sufficiently conservative estimate. Hence, dermal NOAEL(AlH2P3O10) = [corrected NOAEL(AlH2P3O10)] )*( ABSoral/ABSdermal) = (230.33 mg/kg bw/day)*(100/10) = 2303.3 mg/kg bw/day.
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 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:
Remaining differences
AF for intraspecies differences:
5
Justification:
For workers
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.47 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
Modified dose descriptor starting point:
NOAEC
Value:
246.78 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) = ([230.33 mg/kg bw/day]*[60 kg])/([1.4]*[20 m³]) = 493.56 mg/m³. Further, it is assumed that the oral absorption rate is 50% of that of the inhalation absorption. Therefore corrNOAEC(consumer, 24 h) = (493.56 mg/m³)*0.5 = 246.78 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 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:
Remaining differences
AF for intraspecies differences:
10
Justification:
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:
DNEL (Derived No Effect Level)
Value:
16.45 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:
2 303.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is conducted in accordance with ECHA Practical Guide 14, Table 2 by applying the following equation: Dermal NOAEL = (oral NOAEL)*( ABSoral/ABSdermal). Based on the inorganic (ionic) nature of the substance, its molecular weight of ca. 282 g/mol and very low solubility (0.34 mg/L), dermal absorption is considered to be lower than oral absorption. A default value of 10% dermal absorption is taken as a sufficiently conservative estimate. Hence, dermal NOAEL(AlH2P3O10) = [corrected NOAEL(AlH2P3O10)] )*( ABSoral/ABSdermal) = (230.33 mg/kg bw/day)*(100/10) = 2303.3 mg/kg bw/day.
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 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:
Remaining differences
AF for intraspecies differences:
10
Justification:
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.65 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:
230.33 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation needed
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 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:
Remaining differences
AF for intraspecies differences:
10
Justification:
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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

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