Aluminium sulphate

Endpoint summary

Description of key information

Aluminium sulphate has of relatively low subchronic toxicity (NOAEL, oral, rat: 342 mg/kg bw day); 
Aluminium sulphate has of relatively low chronic toxicity (LOAEL, dermal, rat: 13.6 mg/kg bw day); 
Aluminium sulphate has of relatively low chronic toxicity (NOAEC, inhalation, rat: 14.9 mg/m3);

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

342 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEC

14.9 mg/m³

Study duration:

subchronic

Species:

rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Dose descriptor:

LOAEL

13.6 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Additional information

Inhalation exposure

The toxicological literature for subchronic and chronic inhalation exposure studies is limited. Report on several studies of durations of six months (six hours a day, five days a week). The most sensitive and best documented endpoints concerned the respiratory system. The observed effects are those commonly associated with particle inhalation exposure (> 600 μg/m3),(Stone et al.1979) including a thickening of the alveolar walls, and an increase in alveolar macrophages, granulomatous lesions and relative lung weight (ATSDR2006).

 

No studies were located regarding repeated dose toxicity 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

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             

 342mg/kg bw/day

÷1.15m3/kgbw

÷20m3/rat

NOAECrat     14.9 mg/m3

Repeated dose toxicity: via oral route - systemic effects (target organ) neurologic: behaviour; neurologic: brain (multiple sections); other: all gross lesions and masses

Repeated dose toxicity: inhalation - systemic effects (target organ) cardiovascular / hematological: lymph nodes; respiratory: lung

Repeated dose toxicity: dermal - systemic effects (target organ) digestive: liver; digestive: stomach; neurologic: behaviour; neurologic: brain (multiple sections); urogenital: kidneys

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” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

 

 

Directive 67/548

Repeated dose toxicity R33 Danger of cumulative effects. T; R48/23 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation. T; R48/23/24  Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. T; R48/23/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/23/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/24  Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin. T; R48/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. T; R48/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure if swallowed. Xn; R48/20 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation. Xn; R48/20/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. Xn; R48/20/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. Xn; R48/20/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed. Xn; R48/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin. Xn; R48/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. Xn; R48/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure if swallowed.

CLP

Repeated dose toxicity STOT Rep. Exp. 1 STOT Rep. Exp. 2 H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

 

It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for Repeated dose toxicity