Registration Dossier

Administrative data

Description of key information

Subacute toxicity of 7-aminodesacetoxycephalosporanic acid was tested in three studies with Wistar rats, during 7 and 28 days.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
2 700 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

A decrease in ALAT was noted at 900 and 2700 mg/kg bw/day. As a decrease was seen and not an increase (which is considered an induction of liver activity), and since the decrease was not accompanied by other findings indicative of liver toxicity (e.g. liver weight, clinical biochemistry or histopathology), this finding is not considered toxicologically significant.

 

The NOEL is 300 mg/kg bw/day, the NOAEL is 2700 mg/kg bw/day.

Justification for classification or non-classification