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EC number: 203-529-7
CAS number: 107-88-0
No carcinogenic effects were observed in a 2-year feeding study in rats
receiving 10% butane- 1,3 -diol in food (5000 mg/kg bw/day)
and in a 2-year feeding study with dogs, which received 3% butane- 1,3
-diol in food (750 mg/kg bw/day) .
There was no treatment related increase in carcinogenic and
non-carcinogenic effects in treated animals compared to the control.
The incidence of subcutaneous tissue masses was as follows:
The internal tissue masses, concealed in the body cavities, and detected
at autopsy in four male and eight female rats are described in the
Albino rats received 1,3 -butylene glycol in the diet at levels of 1.0,
3.0, and 10.0% (500, 1500, and 5000 mg/kg bw/d) for two years. The
control group was fed the basal laboratory diet (Celanese, 1963a, Scala
and Paynter, 1967). The physical appearance and behaviour of the 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. No compound related adverse effects
were observed. Subcutaneous and internal neoplasms were encountered in a
number of control and test animals, primarily in females. Some of the
neoplasms found at autopsy were identified as fibromas, fibrosarcomas,
carcinomas, or adenomas and melanomas.
In the absence of information on species specific effects or metabolism
the results are regarded as relevant for humans.
In the absence of carcinogenic effects in chronic studies with rats and
dogs and the negative findings in the available mutagenicity assays 1,3
-butylene glycol has not to be classified as carcinogenic according to
the criteria of Regulation (EC) No 1272/2008.
In a chronic feeding study in rats (Celanese, 1963a, Scala and Paynter,
1967), which had methodological deficiencies - number of animals per
dose group too low, no analytical verification of doses - no cancer and
non-cancer effects were observed in the tested dose range (up to 10% 1,3
-butylene glycol in food; 5000 mg/kg bw/d). These data are supported by
a two year feeding study in dogs which received up to 3% 1,3-butylene
glycol in the diet (750 mg/kg bw/d; Celanese, 1963b, Scala and Paynter,
1967). As the dog study did not fulfill the guideline requirements,
especially the number of dogs tested was to low, it was judged not to be
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