Registration Dossier
Registration Dossier
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EC number: 233-135-0 | CAS number: 10043-01-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 15 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 mg/m³
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.71 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):
- 5
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8.55 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No studies were located regarding local and sistemic effects in animals after dermal exposure to various forms of aluminium. For dermal exposure we taken that: -the average weight of rats is 250g (200-300g), -the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg corrected dermal NOAEL= oral NOAEL 342 mg/kg bw/day 0.025 kg = NOAELrat 8.55mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 46.7 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 233.5 mg/kg bw/day
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.882 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.882 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: NOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Workers
Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population
The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF(Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.
A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.
To cover theintra-speciesvariation, the default AF(Assessment factor)of5for workers was applied to the concentration/dose descriptor(NOAEL or NOAEC).
The dose descriptor for dermal irritation/corrosion come from dermal acute study. In this study, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.
We have taken that:
• the average weight of rats is 250g (200-300g), and the average weight of New Zealand White rabbit is 2.4kg used by Lansdown,1973.
• the dose is applied over an area which is approximately 10% of the total body surface, and
• the total body surface of rats is on the average 445 cm2 (363 to 527 cm2) and 1270 cm2of New Zealand White rabbit
used by Lansdown,1973.
The generic modification from the NOAELtest(in mg/kg of body weight) to NOAELmodified(in mg/cm2/day) will be
NOAELtest* 2.4/127= NOAELmodified
The highest dose not causing irritation/corrosion was 233.5 mg/kg bw in the acute study of Lansdown,1973, the modified dose descriptor would be
233.5 mg/kg*2.4kg/127cm2=4.41mg/cm2
Dermal exposure:
No studies were located regarding local effects in animals after dermal exposure to various forms of aluminium.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg = NOAELrat 8.55mg/kg bw/day
No studies were located regarding long term exposure systemic effects in animals after dermal exposure to various forms of Aluminium.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg =NOAELrat 8.55 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 15 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 mg/m³
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.855 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):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8.55 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No studies were located regarding local and systemic effects in animals after dermal exposure to various forms of aluminium. For dermal exposure we taken that: -the average weight of rats is 250g (200-300g), -the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg corrected dermal NOAEL= oral NOAEL 342 mg/kg bw/day 0.025 kg = NOAELrat 8.55mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.35 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 233.5 mg/kg bw/day
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.441 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.441 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- other: NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 34.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 342 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 92.4 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 924 mg/kg bw/day
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
General population
Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population
The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF(Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.
A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.
To cover theintra-speciesvariation, the default AF(Assessment factor)of5for workers was applied to the concentration/dose descriptor(NOAEL or NOAEC).
The dose descriptor for dermal irritation/corrosion come from dermal acute study. In this study, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.
We have taken that:
• the average weight of rats is 250g (200-300g), and the average weight of New Zealand White rabbit is 2.4kg used by Lansdown,1973.
• the dose is applied over an area which is approximately 10% of the total body surface, and
• the total body surface of rats is on the average 445 cm2 (363 to 527 cm2) and 1270 cm2of New Zealand White rabbit
used by Lansdown,1973.
The generic modification from the NOAELtest(in mg/kg of body weight) to NOAELmodified(in mg/cm2/day) will be
NOAELtest* 2.4/127= NOAELmodified
The highest dose not causing irritation/corrosion was 233.5 mg/kg bw in the acute study of Lansdown,1973, the modified dose descriptor would be
233.5 mg/kg*2.4kg/127cm2=4.41mg/cm2
Dermal exposure:
No studies were located regardinglocaleffects in animals after dermal exposure to various forms of aluminium.
Fordermalexposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg = NOAELrat 8.55mg/kg bw/day
No studies were located regarding long term exposure systemic effects in animals after dermal exposure to various forms of Aluminium.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg =NOAELrat 8.55 mg/kg bw/day
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