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Key value for chemical safety assessment

Effects on fertility

Description of key information

Lime Oxide at nominal dose levels of 100, 300 and 1000 mg/kg/day, to rats for a period of 55 days, including throughout gestation and into early lactation for females, resulted in toxicity at 1000 mg/kg/day. Effects consisted of reduced food consumption with associated reductions in body weight gain and reduced grip strength. Clinical chemistry analysis of the blood showed lower than expected blood protein and albumin levels.

Microscopic changes in the bone marrow and lungs were also observed.

Effects at 300 mg/kg/day were confined to lower body weight gain, and reduced food consumption, with minor changes in blood albumin and total protocol for females.

The findings observed at this dose level were considered to be not adverse, therefore the No Observed Adverse Effect level (NOAEL) for systemic toxicity was considered to be 300 mg/kg/day.

No systemic or reproductive toxicity was associated with Lime Oxide administration was observed at the low dose, therefore 100 mg/kg/day was considered to be the No Observed Effect Level (NOEL) for systemic and reproductive toxicity.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimisch 1

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimisch 1

Justification for classification or non-classification

Based on general clinical observation and food comsumption, no classification is warrented.

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