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Administrative data

Description of key information

Acute toxicity after single oral application was tested in male and female rats, which received 5000 mg/kg bw. One female and no male died. The necropsy of the deceased female did not reveal any effect and the death was not found to be treatment-related. The LD50 value for acute oral toxicity is >5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Since in the acute oral toxicity study no effects were observed, the LD50 for a single acute oral administration of Sodium 2 -hydroxyethanesulphonate is 5000 mg/kg bw.

Justification for classification or non-classification

Due to the findings described above (LD50 oral in rats >5000 mg/kg bw) Sodium 2 -hydroxyethanesulphonate should not be classified as acute orally toxic.

It can reasonably be deduced that Sodium 2-hydroxyethanesulphonate does not exert systemic toxic effects after dermal application and thus does not have to be classified, because Sodium 2-hydroxyethanesulphonate did not cause lethal effects after administration of a single oral dose of up to 5,000 mg/kg bw in rats. Furthermore the substance does not have to be classified as skin irritating and it is unlikely that higher amounts than tested in the acute oral toxcity study will be systemically available via the intact skin barrier. Therefore, testing is not scientifically necessary.

In accordance with Section 1.2 of REACH Annex XI, there is sufficient weight of evidence from several independent sources of information leading to the conclusion that Sodium 2-hydroxyethansulphonate does not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because

- the LD50value for acute oral toxicity of Sodium 2-hydroxyethansulphonate is >5000 mg/kg bw,

- Sodium 2-hydroxyethansulphonate does not have to be classified as skin/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 acute inhalation toxicity of Sodium 2-hydroxyethansulphonate is not scientifically necessary.