Reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate

Endpoint summary

Description of key information

Based on the read-across data from ammonium sulphate, the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate is expected to be non-irritating to the skin and the eye.

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:

no adverse effect observed (not irritating)

Additional information

Based on the available information on absorption, distribution, metabolism and excretion properties as well as the available toxicological data of all three components of the reaction mass, it can be concluded, that ammonium sulphate is the most critical substance within the reaction mass. Thus, available data on ammonium sulphate will be used for hazard assessment of the toxicological properties of the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate:

 

Skin

In a primary dermal irritation study, an 80% aqueous suspension of the test substance (purity not further specified) was not irritating when applied to the dorsal skin of rabbits for up to 20 h under occlusive conditions (BASF, 1969). This treatment, harsher than suggested in the OECD guideline, caused only slight, barely visible skin erythema (equivalent to a Draize score of 0) at 24 h. Furthermore, the findings were completely subsided after 8 days. Thus, ammonium sulphate was found to be not irritating to skin. The same was found in a comparative study on dermal irritation with 12 different lots of the test substance (BASF, 1968). No irritation to the intact skin of white rabbit was found when applied as a single dose (20 h) or even after repeated application (5 x 8 h) although moderate irritation was observed following repeated application (5 x 8 h) to the abraded skin, these effects were also completely reversible within 8 days.

Based on the available results, ammonium sulphate can be regarded as not irritating to skin.

 

Eye

In a primary irritation study, 50 µL ammonium sulphate was instilled into the right eyes of 2 Vienna White rabbits (BASF, 1969). Talcum was placed into the adjacent eye for control purpose. Slight edema and conjunctival redness was noted at 1 h after instillation of the test substance; no edema, but still slight redness was present at 24 h. All effects were completely subsided after 8 days. The mean irritation scores for corneal opacity, iris and conjunctival erythema and chemosis were 0, 0, 0.33 and 0, respectively.

Thus, ammonium sulphate can be regarded as not irritating to eyes.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on read-across, the available data on skin and eye irritation are conclusive but not sufficient for classification according to the criteria of Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).