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EC number: 284-366-9
CAS number: 84852-53-9
Guideline- and GLP-compliant 28- and 90-d studies in rats. Results published in the peer-reviewed literature.
The 28 -day no-observed-effect-level (NOEL)
in the Sprague Dawley rat was >= 1,250 mg/kg/d, the highest dose tested,
administered by oral gavage in corn oil. The NOEL was
based on the absence of toxicity at this dose as measured by: body
weight, food consumption, body weight gain, hematology and serum
chemistry values, urinalysis, ocular exam, gross necropsy results, organ
weight, and light microscopic exam of selected tissues.
The 90 -day no-adverse-effect level (NOAEL)
in the Sprague Dawley rat was 1,000 mg/kg/d, the highest dose tested,
administered by oral gavage in corn oil. No animals died on test.
Clinical signs were non-specific, low in incidence, non-dose-related and
not related to test article administration. No test-article-related
ocular lesions were detected on ophthalmic exam. Oral dose levels of up
to 1000 mg/kg/day for 90 days produced no evidence of systemic toxicity,
ocular effects, or treatment-related alterations in urine, serum
chemistry and hematology values in rats. No toxic effect was found on
body weights, body weight gains or food consumption. The only organ
weight affected was liver. Mean liver weights were increased at 1000
mg/kg/day, but not at 320 mg/kg/day, the next lower dose. Low-grade
microscopic liver changes accompanied the increase in liver weights in
male rats. The liver changes were characterized by minimal to slight
hepatocellular vacuolation (high dose males) and minimal to slight
centrilobular hepatocytomegaly (high, and possibly mid dose, males), and
were considered an adaptive response. No changes were found in the
livers of female rats. The liver changes resolved without any delayed or
long-term effect after a 28-day recovery period. The
no-adverse-effect-level (NOAEL) was 1,000 mg/kg/d, and was confirmed in
the UK's review of the study during their assessment of the product.
Non-classification: NOEL in a rat 28 -day
study >= 1250 mg/kg/d; NOAEL in a rat 90-day study = 1,000 mg/kg/d.
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