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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.5 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):
75
Modified dose descriptor starting point:
LOAEC
Value:
36 mg/m³
Explanation for the modification of the dose descriptor starting point:
In the absence of a suitably robust repeated dose inhalation study, the LOAEL of 102 mg/kg bw/d from the oral developmental/reproductive toxicity studies with aluminium nitrate is used. Correction for breathing rate (/0.38) and activity level (*0.67/10) and taking into account the level of oral absorption (0.3%) and inhalation absorption (1.5%) results in a starting point of 36 mg/m3.
AF for dose response relationship:
3
Justification:
use of a LOAEL as the starting point
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
not required; already taken into consideration
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value (workers)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.34 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):
300
Modified dose descriptor starting point:
LOAEL
Value:
102 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No repeated dose dermal toxicity data are available; the NOAEL of 102 mg/kg bw/d from the developmental and reproductive studies with aluminium nitrate are used as a starting point. Dermal absorption is assumed to be equivalent to oral absorption.
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for differences in duration of exposure:
2
Justification:
Extrapolation from subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value (rat study)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value (workers)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The relevant endpoint is the LOAEL of 102 mg/kg bw/d from the develolpmental and reproductive toxicity studies performed with aluminium nitrate.

Inhalation DNEL values

Correction of the oral LOAEL for breathing rate (/0.38) and activity level (*0.67/10) and taking into account the level of oral absorption (0.3%) and inhalation absorption (1.5%) results in a starting point of 36 mg/m3. Assessment factors of 3 (for dose-response), 2 (for duration), 1 (for allometry), 2.5 (for interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) result in an overall assessment factor of 75. Application of the overall assessment factor to the starting point results in a DNEL of 0.5 mg/m3.

The substance is not classified for acute toxicity; there is no evidence of significant systemic toxicity resulting from acute exposure. An acute systemic DNEL is therefore not derived.

The substance is an eye irritant, therefore respiratory irritation may also occur. DNEL values for local effects are not derived in the absence of threshold information; however the potential for inhalation exposure to high concentrations should be minimised through the use of appropriate RMMs.

Dermal DNEL values

Dermal absorption is assumed to be equivalent to oral absorption. Assessment factors of 3 (for dose-response), 2 (for duration), 4 (for allometry), 2.5 (for interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) result in an overall assessment factor of 300. Application of the overall assessment factor to the starting point results in a long-term systemic dermal DNEL of 0.34 mg/kg bw/d for workers.

The substance is not classified for acute toxicity; there is no evidence of significant systemic toxicity resulting from acute exposure. An acute systemic DNEL is therefore not derived.

The substance is not identified as a skin irritant in studies in vivo; however it is noted that aqueous solutions of the substance are of low pH. While the pH of an aqueous solution is unlikely to result in corrosive effects, skin irritation is likely. It is therefore considered prudent to highlight this possible effect, and to specify the use of appropriate personal protective equipment (PPE) as the substance is frequently used as an aqueous solution..

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 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:
LOAEC
Value:
18 mg/m³
Explanation for the modification of the dose descriptor starting point:
In the absence of a suitably robust repeated dose inhalation study, the LOAEL for reproductive and developmental toxicity is used as a starting point. Correction for breathing rate (/1.15) and taking into account the level of oral absorption (0.3%) and inhalation absorption (1.5%) results in a starting point of 18 mg/m3.
AF for dose response relationship:
3
Justification:
use of a LOAEC
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
not required: already accounted for
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 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:
LOAEL
Value:
102 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No repeated dose dermal toxicity data are available; the LOAEL of 102 mg/kg bw/d for reproductive and developmental toxicity is used as a starting point. Dermal absorption is assumed to be equivalent to oral absorption.
AF for dose response relationship:
3
Justification:
use of a LOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor (rat study)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 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:
LOAEL
Value:
102 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No extrapolation required
AF for dose response relationship:
3
Justification:
Use of a LOAEL
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor (rat study)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The relevant starting point is the LOAEL of 102 mg/kg bw/d (Al) from the reproducitve and developmental toxicity studies.

Inhalation DNEL values

Correction for breathing rate (/1.15) and taking into account the level of oral absorption (0.3%) and inhalation absorption (1.5%) results in a starting point of 18 mg/m3. Assessment factors of 3 (for dose-response), 2 (for duration), 1 (for allometry), 2.5 (for interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) result in an overall assessment factor of 150. Application of the overall assessment factor to the starting point results in a DNEL of 0.12 mg/m3.

The substance is not classified for acute toxicity; there is no evidence of significant systemic toxicity resulting from acute exposure. An acute systemic DNEL is therefore not derived.

The substance is an eye irritant, therefore respiratory irritation may also occur. A DNEL value for local effects is not derived in the absence of threshold information; however the potential for inhalation exposure to high concentrations should be minimised.

Dermal DNEL values

Dermal absorption is assumed to be equivalent to oral absorption. Assessment factors of 3 (for dose-response), 2 (for duration), 4 (for allometry), 2.5 (for interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) result in an overall assessment factor of 600. Application of the overall assessment factor to the starting point results in a long-term systemic dermal DNEL of 0.2 mg/kg bw/d for the general population.

The substance is not identified as a skin irritant in studies in vivo; however it is noted that aqueous solutions of the substance are of low pH. While the pH of an aqueous solution is unlikely to result in corrosive effects, skin irritation is likely at high concentrations. It is therefore considered prudent to highlight this possible effect, and to limit the exposure of the general population to aqueous solutions containing the substance at high concentration..

The substance is not a skin irritant or sensitiser; no local hazard is identified. Dermal DNELs for local effects are therefore not derived.

Oral DNEL values

Assessment factors of 3 (for dose-response), 2 (for duration), 4 (for allometry), 2.5 (for interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) result in an overall assessment factor of 600. Application of the overall assessment factor to the starting point results in a long-term systemic oral DNEL of 0.2 mg/kg bw/d for the general population.