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EC number: 204-317-7
CAS number: 119-36-8
In an ICH-compliant study, Acetylsalicylic
acid (ASA) was administered by oral gavage to pregnant New Zealand White
rabbits at 125, 250 or 350 mg/kg bw/day (96, 192, 268 mg/kg as Salicylic
acid (SA)), followed by termination on GD29 (Cappon and al, 2003). 3
does from the high and one doe from the mid dose died between GD14 and
16 and an additional doe aborted on GD22. Necropsy showed evidence of
gastrointestinal toxicity. Maternal body weight gain was significantly
reduced in the mid and high dose groups from GD7 to GD13. Food
consumption was also reduced in these groups. There were no
treatment-related effects on corpora lutea, implantation sites,
pre-implantation losses or embryofoetal mortality. Mean foetal weight
was significantly reduced in the high dose group. There were no
treatment-related visceral or external anomalies. The same study also
administered ASA at higher doses on individual days, DG9, 10 or 11.No
treatment-related malformations were induced in rabbit fetuses by single
dose administrations. The NOAELs were identified: NOAEL (maternal): 125
mg/kg bw/day NOAEL (malformations): 350 mg/kg bw/day NOAEL
(development): 250 mg/kg bw/day.
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