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EC number: 823-920-1
CAS number: 5341-95-7
No toxic effects were observed in a 2-year feeding study in rats
receiving up to 5000 mg 1,3-butylene glycol/kg bw /d (Celanese, 1963a,
Scala and Paynter, 1967) and in a chronic feeding study in dogs
receiving up to 750 mg/kg bw /d (Celanese, 1963b, Scala and Paynter,
1967). In a subchronic feeding study in dogs the NOAEL was 6000 mg/kg bw
and day and the LOAEL 9000 mg/kg bw and day (Reuzel et al., 1978).
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.
No adverse effects compared to control
Rats received 1,3-butylene glycol in the diet at levels of 1.0, 3.0, and
10%, for two years (500, 1500 and 5000 mg/kg/d) (Celanese, 1963a,
Celanese, 1961, Scala and Paynter, 1967). The control group was fed the
basal laboratory diet. The physical appearance and behavior of the test
rats generally was comparable with those of the corresponding controls.
Signs of respiratory involvement were observed with equal frequency
among the control and various test groups. None of the test rats showed
any sign of compound effect.
Mortality in the various groups increased markedly during the second
half of the first year and remained high during the second year of the
study due to respiratory diseases. Hematological values and the results
of urine analyses for treated rats were generally within normal limits
and comparable with those of the controls. Minor abnormalities in
hematological parameters, encountered in control and test animals alike
during the second year, were compatible with inflammatory disease and
Organ weights and ratios were within normal limits and comparable with
the controls. Subcutaneous and internal neoplasms were encountered in a
number of control and test animals, primarily in females. Microscopic
examination of tissue sections did not reveal any consistent alterations.
No adverse effects compared to control.
Calculation of dose in mg/kg bw/d is based on food consumption data of
dogs as given in Gold et al (1984): A carcinogenic potency database of
the standardized results of animal bioassays. Environmental Health
Perspectives 58: 9 -319.
1,3-butylene glycol was fed to adult male and female beagles at dietary
level of 0, 0.5, 1.0, and 3.0% (0, 125, 250, and 750 mg/kg bw/d) for a
period of two years (Celanese, 1963b; Scala and Paynter, 1967). The
physical appearance, behavior, and total food consumption of the test
dogs were comparable with those of the control dogs throughout the
study. No definite signs of compound effect were observed in any of the
test dogs. The results of the hematological, biochemical, and urine
studies showed comparable values for the control and test groups. Organ
weights and organ/body weight ratios of the test animals were generally
within normal limits. Gross and microscopic evaluation of tissues from
dogs sacrificed at one and two years of feeding revealed no consistent
findings. The test dogs were considered to be within normal limits and
comparable with the controls.
In the absence of information on species specific effects or metabolism
the results are regarded as relevant for humans.
Repeated-dose oral toxicity of the source substance butane-1,3 -diol has
been investigated in a 2 -year feeding study in rats (up to 5000 mg/kg
bw/d; Celanese, 1963a; Scala and Paynter, 1967) and a 2 -year feeding
study in dogs (Celanese, 1963b, Scala and Paynter, 1967), which received
up to 750 mg/kg bw/d. In both studies no substance related effects were
observed, even in the highest dose group tested. These data are
supported by the findings of a subchronic feeding study in dogs (Reuzel
et al., 1978). Dogs of the two highest dose groups (9000 and 12000 mg/kg
bw/d) revealed toxic effects like changes in behaviour (epilepsy-like
seizures), haematology, blood biochemistry, organ weights and growth
rate, but no treatment related effects occurred at 6000 mg/kg bw/d. This
study was well performed and judged to be reliable with minor
restrictions (RL2). In contrast, the 2-year feeding studies in rats and
dogs have some methodological deficiencies (e.g. insufficient number of
animals per dose group, no analytical verification of dose), but
contribute to the overall picture of (no) effects of the substance after
The substance has not to be classified for toxicity after repeated
exposure according to Regulation (EC) No 1272/2008, because no toxic
effects were observed in a chronic study in rats (NOAEL 5000 mg/kg
bw/day). Effects in a subchronic study in dogs were only observed at
doses above 6000 mg/kg bw/day (NOAEL 6000 mg/kg bw/day).
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