Registration Dossier
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EC number: 216-343-6 | CAS number: 1562-00-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
None
Additional information
Please refer to "Justification for classification or non-classification"
Short description of key information:
Please refer to "Justification for classification or non-classification"
Effects on developmental toxicity
Description of key information
The developmental properties of Sodium 2-hydroxyehtansulphonate were studied in a developmental toxicity study in rats. Four groups of females were dosed with 0, 50, 200 and 1000 mg/kg bw/d from day 0 to day 20 post coitum. All females were sacrificed on day 21 post coitum and the fetuses were removed by Caesarean section. All dams survived. No maternal or developmental effects were observed up to 1000 mg/kg bw/d.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
Please refer to "Justification for classification or non-classification"
Toxicity to reproduction: other studies
Additional information
None
Justification for classification or non-classification
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 cause toxicity to reproduction and thus does not have to be classified, because
- Sodium 2-hydroxyethansulphonate caused no irreversible or severe systemic toxic effects in a 90-day oral gavage study in rats (NOAEL 200 mg/kg/day) especially to reproductive organs,
- Sodium 2-hydroxyethansulphonate did not cause any maternal or developmental effect in a developmental study in rats
- Sodium 2-hydroxyethansulphonate does not have to be classified as skin sensitizing or as skin or eye irritating, indicating that its very low tendency to interact with living cells and tissue.
It can therefore be concluded with sufficient certainty that Sodium 2-hydroxyethansulphonate will not cause toxicity to reproduction and that testing is not scientifically necessary.
The developmental toxicity of Sodium 2-hydroxyethansulphonate was evaluated in rats according to OECD guideline 414 study and GLP. No maternal and developmental effects were observed up to 1000 mg/kg bw/d.
Therefore, it is concluded that Sodium 2-hydroxyethansulphonate is not subject to classification and labelling according to Directive 67/548/EEC and Regulation 1272/2008/EC regarding reproductive toxicity.
Additional information
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