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EC number: 247-156-8
CAS number: 25640-78-2
High dose (not explicitely specified
but probably above 200 mg/kg bw/day) gave rise to nephrotoxicity, the
formation of renal lesions, and the presence of small calculi in the
renal pelvis and bladder. Histologically, interstitial nephritis and
papillary atrophy, oedema, degeneration and necroses were detected.
The renal pelvis, ureters and bladder
contained concretions that ranged from amorphous chalky material in the
pelvis of some animals to bladder stones in others. From collected
calculi which were resistant to enzymatic hydrolysis but not to 6 M HCl, the
biphenyl derivative of methylglycolic acid could be isolated, a
metabolite of isopropylbiphenyl. Its calcium salt is insufficiently
soluble to be readily excreted into the urine. It tends to become
sequestered in a crystalline state in the renal tubules over time
thereby producing renal toxicity. Renal toxicity of isopropylbiphenyl
may especially be evident in species which predominantly form 2-biphenyl methylglycolic
acid (2 -biphenyl lactic acid) as major metabolite.
Comprehensive results from long-term
toxicity testing are not accessible. In a pharmacological test
programme, one key endpoint for a relevant constituent in MIPB isomer
mixture had been identified, potential nephrotoxicity. The limited
information available does not enable one to draw robust conclusions
about the toxicity profile of 4-IPB or the target compound, MIPB isomer
mixture. However, in synopsis with the results from species-specific
metabolic studies, the authors´ conclusion about that nephrotoxicity
would be unlikely to develop in humans is taken for granted (see
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
Only relevant publication on an MIPB component, NOAEL defined in
study is provisional
Repeated dose toxicity: via oral route - systemic effects (target
organ) urogenital: kidneys
Based on the current data, no classification
for specific organ toxicity (STOT) is required.
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