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Description of key information

No information is available with Uronium hydrogen sulphate as an aduct of urea and sulphuric acid.
As Uronium hydrogen sulphate readily degrades to urea and sulfuric acid and/or sulfate ions in the human body, the assessment of the repeated toxicity of urea sulphate is based on the data available on the degradation products:
- Sulfates (as calcium salt): no severe toxicological effect was observed after oral administration of (calcium) sulfate. In a Combined Repeated Dose and Reproduction/Developmental Toxicity Screening Test in rats [OECD TG 422] with calcium sulphate dihydrate, the LOAEL and NOAEL were determined to be 300 mg/kg bw/day and 100 mg/kg bw/day for male rats, and the NOAEL for females was 1000 mg/kg bw/day.
- Urea: 12-month carcinogenicity screening studies in the rat and mouse demonstrate that urea is of very low chronic toxicity by the oral route. Similarly, no evidence of local or systemic toxicity was seen in 4-week and 25-week dermal toxicity studies in the rat.

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

No information on repeated toxicity is available with urea sulfate as an aduct of urea and sulphuric acid. As urea sulfate readily degrades to urea and sulfuric acid and/or sulfate ions in the human body, the assessment is based on the data available on the degradation products, urea and sulfates (as calcium salt).

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