Aluminium sulphate

Endpoint summary

Description of key information

No skin irritation and corrosion reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw
Instillation of aluminum sulphate into the eye results in conjunctivitis and purulent ophthalmitis. Aluminum sulphate and coagulants afflict the nervous system, liver and heart. The recommended MAC in the air of workplace for aluminum sulphate, is equal to 0.5 mg/m3. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin damage has been observed in female TF1 Carworth mice, New Zealand rabbits, and Large White pigs following the application of 10% aluminum chloride (0.005–0.1 g Al) or aluminum nitrate (0.006–0.013 g Al) for 5 days; but not from aluminum sulfate, hydroxide, acetate, or chlorhydrate (Lansdown1973). The damage consisted of hyperplasia, microabscess formation, dermal inflammatory cellinfiltration, and occasional ulceration. These results suggest that the development of adverse dermaleffects from exposure to aluminum depends upon its chemical form..

The 10% solutions of aluminium chloride produced a slightly corrosive effect.

In occupational settings, instillation of aluminium sulphate into the eye, have resulted in conjunctivitis and purulent ophthalmitis (Grekhova et al., 1994). Other forms of aluminium relevant to cosmetics (aluminium starch octenylsuccinate) have also been shown to cause mild eye irritation in rabbits, although the authors concluded that this exposure was unlikely to cause irritation in humans (Nair & Yamarik, 2002).

References: Nair B,Yamarik TA; Final report on the safety assessment of aluminum starch octenylsuccinate., Int J Toxicol. 2002;21 Suppl 1:1-7.

 

Effects on eye irritation: moderately irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Justifiction for eye classification:

Instillation of aluminum sulphate into the eye results in conjunctivitis and purulent ophthalmitis. Aluminum sulphate and coagulants afflict the nervous system, liver and heart. The recommended MAC in the air of workplace for aluminum sulphate, is equal to 0.5 mg/m3.

Classification: Eye Damage 1

H318: Causes serious eye damage.

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	Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R41 Risk of serious damage to eyes
CLP	Skin Corrosivity  H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation  H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage

 

 

 

 

It is concluded that the substance aluminium sulphate meet the criteria to be classified for human health hazards for Dermal-local effect:R41 Risk of serious damage to eyes, Eye Damage 1, H318: Causes serious eye damage.

 

Justification for skin non-classification:

Conclusive but not sufficient for classification

No skin irritation and corrosion reactions were observed with aluminium sulphate treatment up to 233.5 mg/kg bw.