Registration Dossier

Administrative data

Description of key information

Sodium 2-hydroxyethanesulphonate has been tested in vivo for irritative properties in one skin irritation test and in one eye irritation test in rabbits. The substance caused no irritation to the skin and only swelling of the lids and redness of the conjunctiva and iris one hour after application in the eyes. These symptoms were reversible by 48 hours. The test substance is not considered irritating according to criteria of the EU dangerous substances directive.

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

- Skin irritation was tested in a guideline study according to OECD guideline 404 in rabbits. 24 hours up to three days after treatment, the skin did not show any sign of erythema or edema. Mean scores on all observation time points after application were 0 for the three animals.

- Eye irritation was tested in a guideline study according to OECD guideline 405 in rabbits. The substance caused swelling of the lids and redness of the conjunctiva and iris one hour after application in the eyes. The mean score for three animals on day 1, 2 and 3 for chemosis and redness of the conjunctiva was 0.2 and 0.7, respectively. These symptoms were fully reversible by 48 hours.

Justification for classification or non-classification

- Sodium 2-hydroxyethanesulphonate has been tested in vivo for irritative properties in one skin irritation test in rabbits. The substance caused no irritation to the skin. Therefore, Sodium 2-hydroxyethanesulphonate does not have to be classified as skin irritating.

- Sodium 2-hydroxyethanesulphonate has also been tested in vivo for irritative properties in one eye irritation test in rabbits. The substance caused swelling of the lids and redness of the conjunctiva and iris one hour after application in the eyes. The mean score for three animals on day 1, 2 and 3 for chemosis and redness of the conjunctiva was 0.2 and 0.7, respectively These symptoms were reversible by 48 hours. The test substance is not considered eye irritating according to criteria of the EU dangerous substances directive.

- It can reasonably be deduced that Sodium 2-hydroxyethanesulphonate does not cause respiratory tract irritation and thus does not have to be classified, because the substance did cause only slight, fully reversible irritative effects in the eyes and no effects on the skin. It does not have to be classified as either skin or eye irritating. Therefore, Sodium 2-hydroxyethanesulphonate, in the unlikely event of being inhaled as a dust, is considered not to cause severe effects, due to its not-/slightly irritating properties on skin and eye. A harmful interaction with living cells and tissues is very unlikely (as demonstrated by the in vivo skin and eye irritation studies).