6-aminopenicillanic acid

Endpoint summary

Description of key information

Repeat dose toxicity was determined by a 28-day study conducted to GLP and to current accepted guidelines.

Also a 14-day repeat dose toxicity study is available,  which is well documented  and GLP compliant. No guidelines are available for range finding studies, however the study conforms to the principals of current accepted guidelines for repeat dose oral studies.

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

14 -Day repeat dose toxicity study:

No clinical signs of toxicity were detected for test or control animals throughout the study period. Isolated instances of increased salivation were evident post dosing, in animals of either sex treated with 1000 mg/kg/day throughout the treatment period and in animals of either sex treated with 500 mg/kg/day on Day 14. Such observations are often recorded following the oral administration of an unpleasant tasting and/or locally irritant test material formulation and are considered of no toxicological importance. The test material administered at doses of 1000, 500 and 250 mg/kg/day resulted in treatment-related effects at 1000 and 500 mg/kg/day. The effects detected in this study were considered not to represent an adverse health effect, therefore a No Observed Adverse Effect Level (NOAEL) and a suitable high dose level for use on a twenty-eight day study were considered to be 1000 mg/kg/day.

28 -Day Repeat dose toxicity study:

The oral administration of 6-aminopenicillanic acid at dose levels of 30, 300 and 1000 mg/kg/day for a period of twenty eight consecutive days did not result in any toxicologically significant effects in animals of either sex treated with 30, 300 or 1000 mg/kg/day. The "No Observed Adverse Effect Level" *NOAEL) was therefore considered to be 1000 mg/kg/day.