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EC number: 700-002-8
CAS number: 1333483-07-0
No adverse effects were observed in a 28-day gavage study in rats (OECD 407, GLP) at doses of up to 1000 mg/kg bw (NOTOX 2009b and c).
Repeated dose toxicity was assessed in a subacute gavage study in rats following OECD guideline 407 and GLP (NOTOX 2009b). Based on the results of a 5-day range finding study (NOTOX 2009c), the dose levels were selected to be 0, 30, 300 and 1000 mg/kg/day. The test substance, formulated in 1% aqueous carboxymethyl cellulose, was administered daily for 28 days by oral gavage to SPF-bred Wistar rats. One control group and three treated groups were tested, each consisting of 5 males and 5 females. An extra 5 animals per sex in the control and high dose group were allowed 14 days of recovery.
Animals at 300 and 1000 mg/kg/day showed yellow faeces and/or green contents of the gastrointestinal tract. Based on the absence of any supportive pathological alterations in animals at 1000 mg/kg/day and the test substance being a yellow pigment, these findings were considered to be related to staining properties of the test substance and of no toxicological significance.
No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). The NOEL for subacute oral toxicity in rats is 1000 mg/kg bw.
Classification, Labelling, and Packaging Regulation (EC) No.
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. There were no
significant toxic effects at doses of less than 300 mg/kg bw upon
subacute oral exposure in rats. As a result the substance is not
considered to be classified for repeated dose toxicity in Category 2 or
1 under Regulation (EC) No. 1272/2008.
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