Registration Dossier

Administrative data

Description of key information

Uronium hydrogen sulphate is not considered as irritant to the skin, but is severely irritant to the eyes.

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)

Additional information

Skin irritation:

In a primary dermal irritation study in rabbit (OECD 404, GLP), urea sulphate was not considered as a skin irritant: mean ratings of erythema and edema at 24, 48 and 72 hours of the three animals after a 4-hour exposure were 1.22 (erythema) and 0.22 (edema).

Eye irritation:

As a corrosive effect was observed during the skin sensitisation test (see section 7.4.1), only an in-vitro eye irritation test (HETCAM) was performed. In this test, severe irritating effects were observed during 5 min incubation with urea sulfate. The calculated mean irritancy index is 10.27 and it was concluded that the test item possesses an irritating potential. As the test item is considered to be corrosive, no further in-vivo test is required.


Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin irritation:

Data are conclusive for skin irritation, but not sufficient for classification according to CLP criteria (Regulation (EC) No 1272/2008). No classification is proposed for skin irritation according to CLP.

 

Eye irritation:

Data are conclusive for eye irritation, and sufficient for classification according to CLP criteria (Regulation (EC) No 1272/2008). Uronium hydrogen sulphate is classified as Eye Damage category 1 (Causes serious eye irritation).