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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Immunotoxicity

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Administrative data

Description of key information

Orale exposure:
After three months treatment with Al2(SO4)3 in a dose of 300 mg/kg bw., hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferritin with Al, but Vit E had no effect on the changes of all blood and liver parameters caused by Al. From the results presented in this report, a Lowest Observed Adverse Effect Level (LOAEL) for Aluminium sulfate of 300 mg/kg/day was established, based on significantly decreased hemoglobin and hematocrit levels of Al .
Inhalation exposure:
Several animal studies have found histological alterations in the lymphoreticular system, in particular granulomas in the hilar lymph nodes; these effects are secondary to the pulmonary effects (Steinhagen et al. 1978; Thomson et al. 1986) and resulted from the removal of aluminum from the lungs by alveolar macrophages.
Dermal exposure:
No studies were located regarding immunological/lymphoreticular effects in animals after dermal exposure to various forms of aluminum.

Key value for chemical safety assessment

Effect on immunotoxicity: via oral route

Endpoint conclusion
Dose descriptor:
LOAEL
300 mg/kg bw/day

Effect on immunotoxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
NOAEC
3.8 mg/m³

Effect on immunotoxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LOAEL
7.5 mg/kg bw/day

Additional information

Orale exposure:

After three months treatment with Al2(SO4)3 in a dose of 300 mg/kg bw., hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferritin with Al, but Vit E had no effect on the changes of all blood and liver parameters caused by Al. From the results presented in this report, a Lowest Observed Adverse Effect Level (LOAEL) for Aluminium sulfate of 300 mg/kg/day was established, based on significantly decreased hemoglobin and hematocrit levels of Al .

Inhalation exposure:

Several animal studies have found histological alterations in the lymphoreticular system, in particular granulomas in the hilar lymph nodes; these effects are secondary to the pulmonary effects (Steinhagen etal. 1978; Thomson et al. 1986) and resulted from the removal of aluminum from the lungs by alveolar macrophages.

Dermal exposure:

No studies were located regarding immunological/lymphoreticular 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 LOAEL= oral LOAEL

300 mg/kg bw/dw 0.025 kg =

LOAELrat 7.5 mg/kg bw/day

 

Justification for classification or non-classification

There are conclusive but not suffcient data for the classification of substance Aluminium sulphate with regard to immunotoxicity.