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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
LOAEC

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
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Dose descriptor starting point:
LOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.72 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
467 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.2 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.2 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

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 the intra-species variation, the default AF(Assessment factor)of 5 for 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 2.5 kg 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* 2.5/127= NOAELmodified

The highest dose not causing irritation/corrosion was 2335 mg/kg bw in the acute study of Lansdown,1973, the modified dose descriptor would be

2335 mg/kg*2.5 kg/127cm2=46 mg/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 8.6 mg/kg bw/day

No studies were located regarding systemic effects in animals after dermal exposure to various forms ofaluminium.

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 LOAEL= oral LOAEL

544 mg/kg bw/day 0.025 kg =

LOAELrat 13.6 mg/kg bw/day

 

Inhalation exposure:

The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.

NOAELrat             

 342 mg/kg bw/day

÷1.15m3/kg bw

÷20m3/rat

NOAECrat     14.9 mg/m3

 

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
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
LOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
LOAEC

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
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
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:
1.36 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
233.5 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.6 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.6 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
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:
54.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
92.4 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

General population

Following the “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health”, 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.

Although other values have been proposed, defaults typically suggested for the general population (representing all age groups, including children and elderly) are a factor of 10.

To cover theintra-species variation, the default AF (Assessment factor)of 10 for General population 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 rabbitis 2.5 kg 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 1270cm2of 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* 2.5/127= NOAELmodified

The highest dose not causing irritation/corrosion was 2335mg/kg bw in the acute study of Lansdown,1973, the modified dose descriptor would be

2335 mg/kg*2.5kg/127cm2=46mg/cm2

Dermal exposure:

No studies were located regarding local effects in animals after dermal exposure to various forms ofaluminium.

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

342mg/kg bw/day 0.025 kg =

NOAELrat 8.6 mg/kg bw/day

No studies were located regarding systemic effects in animals after dermal exposure to various forms ofaluminium.

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 LOAEL= oral LOAEL

544 mg/kg bw/day 0.025 kg =

LOAELrat 13.6 mg/kg bw/day

 

Inhalation exposure:

The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.

NOAELrat             

 342 mg/kg bw/day

÷1.15m3/kgbw

÷20m3/rat

NOAECrat     14.9 mg/m3