Aluminium sulphate

Endpoint summary

Description of key information

Human Toxicity Values:
Human data indicate a very low acute toxicity of aluminium sulphate. 
Human clinical experience indicates that very high oral doses of aluminium sulphate,
300 mg/kg bw  up to 20 grams for an adult, are well tolerated, except from (intentionally) 
causing severe diarrhoea. WHO/FAO set conclusive but not sufficient data  an AD for aluminium sulphate.
  
The acute oral LD50 values for aluminium sulphate  is>4618 mg/kg bw (OECD TG 423). 
The acute inhalation NOAEL values for aluminium sulphate is 10 m3/kg air.
The acute dermal LD50 values for aluminium sulphate  is>2335 mg/kg bw .
No adverse clinical signs were observed. 
Non-Human Toxicity Values: 
LD50 Mouse (Swiss) oral 4618mg/kg bw  (OECD TG 423)
LD50 Rat oral >5000 mg/kg bw (OECD TG 401)
LD50 Dobra Voda Mouse oral 6200 mg/kg
LD50 Rat oral 1930 mg/kg bw  (OECD TG 423)
LD50 Mouse (Swiss) ip 253 mg /kg bw
LD50 Rat (Sprague Dawley) ip 158mg/kg bw
LD50 Mouse ip 1735 mg/kg
LD50 Mouse ip 6.3 mg/kg
LD50 Guinea pig oral 490 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

4 618 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Dose descriptor:

discriminating conc.

Value:

50 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 335 mg/kg bw

Additional information

Oral exposure

 

The oral LD50 (lethal dose, 50% kill, single administration) for different aluminum salts, as measured in different strains of mice, rats, guinea pigs and rabbits, varies according to the aluminum salt administered as well as according to the experimental animal species.

In an early review an LD50 of apparently 6,200 mg /kg bw was reported for Al2(SO4)3 and of 3,850 mg Al/kg bw for Al(Cl)3 administered to mice (Sorenson et al. 1974).

In a study of oral and intraperitoneal administration during 14 days, Llobet et al. (1987) estimated the acute oral toxicity of aluminum chloride, nitrate and sulphate in Sprague-Dawley rats and Swiss mice.

Aluminum chloride and nitrate produced acute toxicities of similar magnitude (LD50 of 222 to 370 mg Al/kg) in the mice and rats, whereas the toxicity of aluminum sulphate was considerably lower (LD50> 4620 mg/kg in both species).

Inhalation exposure

 

In Golden Syrian hamsters and New Zealand rabbits exposed over a short duration (four to six hours per day for three to five days at levels of 7 to 200 mg/m3) to aluminum chlorohydrate through inhalation, the effects observed are those typically associated with inhalation of particulate matter, including alveolar wall thickening, increased number of macrophages and increased lung weight (ATSDR 2006).

 A more detailed discussion of the pulmonary effects in experimental animals of inhalation exposure to aluminum oxide dust and refractory alumina fibres, and aluminum hydroxide is provided by Krewski et al. (2007).

The observed responses to various species of aluminum are described as “typical of foreign body reaction”, including alveolar proteinosis and wall thickening, and some nodule formation.

 

Dermal exposure

 

Dermal effects of aluminum compounds (10% w/v chloride, nitrate, chlorohydrate, sulphate, hydroxide) applied to skin of mice, rabbits and pigs over five-day periods (once per day) include epidermal damage, hyperkeratosis, acanthosis and microabscesses (ATSDR 2006; Krewski et al. 2007).

Justification for classification or non-classification

Based on the hazard assessment of aluminium sulphate in section 2.1 and 2.2.in IUCLID 5.2., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” and according to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Very Toxic (T+) R28: Very toxic if swallowed R27: Very toxic in contact with skin R26: Very toxic by inhalation R39/26 R39/27 R39/28: Dangerous of very serious irreversible effects Toxic (T):  R25: Toxic if swallowed R24: Toxic in contact with skin R23: Toxic by inhalation R39/23 R39/24 R39/25: Danger of very serious irreversible effects Harmful (Xn): R22: Harmful if swallowed R21: Harmful in contact with skin R20: Harmful by inhalation R65: Harmful may cause lung damage if swallowed R68/20 R68/21 R68/22: Possible risk of irreversible effects Other toxicological properties R67: Vapours may cause drowsiness and dizziness

CLP

H300 Acute Tox. 2 Fatal if swallowed H310 Acute Tox. 1 Fatal in contact with skin H330 Acute Tox. 2 Fatal if inhaled H370 STOT SE 1 H301 Acute Tox. 3 Toxic if swallowed H311 Acute Tox. 3 Toxic in contact with skin H331 Acute Tox. 3 Toxic if inhaled H370 STOT SE 1 H302 Acute Tox. 4 Harmful if swallowed H312 Acute Tox. 4 Harmful in contact with skin H332 Acute Tox. 4 Harmful if inhaled H304 Asp. Tox. 1 H371 STOT SE 2 (May cause damage to organs (or state all organs affected if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) Other toxicological properties H336 STOT SE 3 May cause drowsiness or dizziness

 

It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for acute effects.

 

Aluminium sulfate has of relatively low acute toxicity (LD50, oral, mouse: 4618 mg/kg bw;

No epidermal and pathological changes and dermal reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw.

Aluminium sulfate has of relatively low acute inhalation toxicity. The acute inhalation NOAEL values for aluminium sulphate is >10 m3/kg air.