Registration Dossier

Administrative data

Description of key information

Oral administration of Sodium 2-hydroxyethanesulphonate to Wistar rats at doses of 50, 200 and 1000 mg/kg/day for 91/92 days resulted in no deaths, no clinical signs during daily or weekly observations, no clinical signs during the functional observational battery, no test item-related differences in the mean fore-or hindlimb grip strength or mean locomotor activity, no toxicologically relevant ophthalmoscopic changes, no differences in the mean food consumption, no changes in hematology parameters at 200 mg/kg/day or at 50 mg/kg/day, and no changes in urinalysis parameters at 50 mg/kg/day. 
Although statistically significant differences were noted in the mean hindlimb grip strength values of males treated with 1000 mg/kg/day, these were considered to be secondary effects to the lower body weights.
Test item-related findings were generally restricted to slightly lower mean absolute and relative body weights in males treated with 1000 mg/kg/day, light changes in the hematology parameters of the rats treated with 1000 mg/kg/day, increased spleen weights in rats at 1000 mg/kg/day, and macroscopical changes in the liver and spleen.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
200 mg/kg bw/day

Additional information

Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: spleen; digestive: liver

Justification for classification or non-classification

Due to the NOAEL of 200 mg/kg bw/day in a 90 day oral gavage study in rats, Sodium 2-hydroxyethanesulphonate does not have to be classified regarding systemic and target organ toxicity after repeated exposure according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

It can reasonably be deduced that Sodium 2-hydroxyethanesulphonate does not exert systemic toxic effects after repeated dermal application and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and that testing is not scientifically necessary, because

- Sodium 2-hydroxyethanesulphonate caused no relevant systemic effects and revealed a NOAEL of 200 mg/kg/day in a 90 day oral gavage study in rats, and

- Sodium 2-hydroxyethanesulphonate does not have to be classified as skin irritating. Therefore, it is unlikely that higher amounts than tested in the subchronic oral toxcity study will be systemically available via the intact skin barrier

 

It can reasonably be deduced that Sodium 2-hydroxyethanesulphonate does not have to be classified regarding systemic and target organ toxicity after repeated inhalation exposure according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and that testing is not scientifically necessary, because

- Sodium 2-hydroxyethanesulphonate caused no relevant systemic effects and revealed a NOAEL of 200 mg/kg/day in a 90 day oral gavage study in rats,

- Sodium 2-hydroxyethanesulphonate does not have to be classified as skin or eye irritating, and

- inhalation is very unlikely to occur, since the substance is handled as aqueous solution during production process.
Therefore, it is concluded that testing of chronic inhalation toxicity of Sodium 2-hydroxyethansulphonate is not scientifically necessary.