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EC number: 246-186-9
CAS number: 24347-58-8
In a subchronic (13-week) feeding study dogs were fed with a diet
containing 1,3-butylene glycol, resulting in intake levels of 0, 3000,
6000, 9000 and 12000 mg/kg bw/d (Reuzel et al., 1978). Epilepsy-like
seizures were frequently observed in dogs fed 9000 or 12000 mg of the
test item/kg bw/d. Body weight gain was depressed in dogs fed 9000 or
12000 mg/kg bw/d. Thrombocyte counts were increased at 6000 mg/kg bw/d
and above. Methaemoglobin was elevated in dogs of the top-dose group
only. Blood levels of free fatty acids, beta-hydroxy butyric acid,
aceto-acetic acid and lactate increased with increasing feeding levels
of the test item. Kidney and liver function was not affected. Slight
ketonuria was observed in dogs of the top-dose group at week 12. Small
quantities of the test item were recovered from feces of dogs fed 9000
or 12000 mg/kg bw/d. The relative weights of the liver and adrenals
showed dose-related increases in the two highest dose groups. In
addition, the top-dose group showed increased relative weights of the
kidneys, brain and lungs and decreased relative weights of the thymus
and spleen. Gross and microscopic examination failed to reveal any
changes that could be ascribed to treatment. The NOAEL in the present
study was 6000 mg/kg bw/d.
The study used as source investigated sub-chronic toxicity over a 13
weeks period in dogs. The study results of the source compound were
considered applicable to the target compound in a WoE approach, and were
used for classification and labelling acc. to Regulation (EC) No
1272/2008. Justification and applicability of the read-across approach
(structural analogue) is outlined in the read-across report in section
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