Registration Dossier

Administrative data

Description of key information

Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD 422)
- NOAEL: 1000 mg/kg bw/day

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
Study duration:
subacute
Species:
rat

Additional information

The key study was a 28-day Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test performed according to OECD 422 under GLP conditions, in which a NOAEL of 1000 mg/kg bw/day was established based on the absence of adverse effects up to the highest dose.

Justification for classification or non-classification

When considering the NOAEL of 1000 mg/kg bw/day and the guidance values for classification as outlined in Annex I of 1272/2008/EC (significant effect observed at 300 mg/kg bw/day) and Annex VI of 67/548/EEC (significant effect observed at 150 mg/kg bw/day), P-slag does not need to be classified for repeated dose toxicity.