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EC number: 204-327-1
CAS number: 119-47-1
No studies on toxicokinetics of
6,6'-di-tert-butyl-2,2'-methylendi-p-cresol (DBMC) are available.
However, considering the toxicokinetic profile of structural analogues
and taking into account the experiences with DBMC in acute and repeated
dose toxicity studies, a characterization of DBMC toxicokinetics can be
DBMC is a solid powder with a low vapour pressure (calculated to be
below 0.1hPa, 20°C) under normal ambient conditions, therefore
inhalation exposure to the vapour might be negligible.
DBMC is practically insoluble in water (0.007 g/l at 20°C). However, the
molecular mass of 342 g/mol and the n-octanol/water coefficient (log Pow
of 6.25) suggest intestinal absorption subsequent to oral ingestion.
This assumption is confirmed by data from acute oral toxicity studies
and repeated dose toxicity studies. However, acute toxicity is low
because LD50 values are high (greater than or even to 5000 mg/kg bw,
Hagan 1952, Garlanda 1962, Stasenkova 1977, Sumitomo Chemical 1977,
Takaki 1994, EPA 1992 Monsanto study); systemic availability was
indicated by clinical signs like hypoactivity and ataxia at doses = 2500
mg/kg bw (EPA 1992 Monsanto study). In addition, studies with repeated
oral dosing of rats indicating bioavailability of the compound by
showing dose related toxic effects at doses > 12.7 mg/kg bw,
predominantly in the testes and liver. Available repeated dose toxicity
studies are a subacute toxicity study with rats (MHWJ 1996), subchronic
toxicity studies with rats (Bayer AG 1982, Takagi 1994) or dogs
(American Cyanamid Company 1965), a chronic feeding study with rats
(Takagi 1994) and a reproduction toxicity screening study (MHWJ 1999).
The determined NOAELs in these studies were in the order of 10 mg/kg
DBMC showed a very low irritating potential in humans (Kimmerle 1958,
American Cyanamid Company 1959) and rabbits (EPA 1992 Monsanto study).
In addition, Vulkanox BKF had a very low skin sensitization potential in
humans (American Cyanamid Company 1959). Furthermore, the dermal LD50 of
above 2000 mg/kg and the absence of significant signs of systemic
toxicity when dosed once at 2000 mg/kg bw (EPA 1992 Monsanto study)
reveal a low toxic potential of DBMC after dermal exposure.
The formation of DNA reactive metabolites in unlikely, since in vitro
and in vivo mutagenicity tests (Ames assay MHWJ 1996, RCC 1986a, in
vitro chromosome aberration assay MHWJ 1996, in vivo micronucleus assay
RCC 1986b ) show negative results. In addition, the cytotoxicity of the
test substance DBMC was reduced in the presence of the rat liver
microsomal fraction. This suggests that detoxification of DBMC occurs as
a result of liver enzyme activity or even as a detoxification by
Assessment of toxicokinetic behaviour
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