Registration Dossier

Administrative data

Description of key information

Oral:  NOAEL of 1000 mg/kg/day (highest dose tested) in rats to be clearly established.(EEC Directive 92/69/EEC, Method B7) 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Additional information

In a 28-day repeat dose oral toxicity study in rats, there were statistically significant findings related to clinical chemistry, organ weight parameters, and macroscopic and microscopic changes in the kidney and lung. However, the findings were not dose-related and were considered not to be treatment-related. The results of the study allowed an NOAEL of 1000 mg/kg/day (highest dose tested) to be clearly established. Moreover,the laboratory facilities which complying with OECD Principles of Good Laboratory Practice were utilized in order to ensure the consistency and reliability for the results.

This study was utilized as a key study in substance repeated dose toxicity evaluation due to the high adequation, reliability and relevance to this element.

Justification for classification or non-classification

According to the existing studies in a 28 -day repeated dose oral toxicity test in laboratory animals, which provide sound conclusive evidence that the substance (CAS:5945-33-5 ) was considered as low toxicity via oral route. Further studies which focus on other administration routes such as inhalation and dermal exposures may be considered depend on the nature of the substance and the likely route of human exposure.