Subchronic Toxicity Studies of <i>t</i>-Butyl Alcohol in Rats and Mice

Lindamood, Charles; Farnell, Daniel R.; Giles, Herschell D.; Prejean, Joseph; Collins, Jeffrey J.; Takahashi, Koji; Maronpot, Robert R.

doi:10.1093/toxsci/19.1.91

Cited by 14 publications

(20 citation statements)

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“…In short-term oral studies in rats, terc-butanol at 2% (w/v) or less in drinking water did not cause a gross organ or tissue damage in mice, although weight loss was reported and a microscopic damage to livers and kidney and alterations such as centrilobular necrosis, vacuolation in hepatocytes, and a loss of hepatic architecture were noted. Subchronic oral dosing with tert-butanol increased mineralization of kidney, nephropathy, and urinary bladder transitional cell epithelial hyperplasia in rats (Lindamood et al 1992). Also a liver damage, chronic inflammation, hyperplasia of transitional cell epithelium urinary, and proliferative changes including hyperplasia and neoplasia in the thyroid in mice were observed (Chen 2005).…”

Section: Animal and Human Toxicitymentioning

confidence: 99%

Toxic Alcohols: Aliphatic Saturated Alcohols

Patočka¹,

Kuča²

2012

Mil. Med. Sci. Lett.

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SummaryToxic alcohols that clinicians commonly encounter are ethylene glycol, methanol, and isopropanol. Adults ingest these either for suicidal intent or to achieve inebriation, since these substances are readily available and cheaper than alcohol. Nevertheless, assorted alcohols are used very often in many applications and any alcohol can be toxic if ingested in large enough quantities. Toxic alcohols discussed here include all saturated aliphatic alcohols containing from 1 to 6 carbons in their molecules.

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Section: Animal and Human Toxicitymentioning

confidence: 99%

Toxic Alcohols: Aliphatic Saturated Alcohols

Patočka¹,

Kuča²

2012

Mil. Med. Sci. Lett.

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“…At necropsy, the animals from the 4% dose group had several atrophic organs and occasional calculi in the urinary bladder and urinary tract. Except for one male in the 2% dose group that had calculi in the urinary bladder, no gross lesions were identified in the remaining treated groups (13).…”

Section: Resultsmentioning

confidence: 90%

Retrospective study of possible alpha-2 mu-globulin nephropathy and associated cell proliferation in male Fischer 344 rats dosed with t-butyl alcohol.

Takahashi¹,

Lindamood²,

Maronpot³

1993

Environ Health Perspect

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Tert-butyl alcohol, an important commodity chemical, additive to unleaded gasoline, and contaminant of drinking water, was evaluated for toxicity and was found to enhance nephropathy in male Fischer 344 rats. Because male rats treated with t-butyl alcohol for 2 years had a low incidence of renal cortical tumors, additional renal sections for the 90-day toxicity study were examined for the presence of hyaline droplet accumulation, nephropathy, and evidence of replicative DNA synthesis (S-phase nuclei) to indirectly and retrospectively investigate a possible role of a-2p-globulin in the pathogenesis of the nephropathy. Dose levels for t-butyl alcohol were 0, 0.25, 0.5, 1, 2, and 4% (w/v) administered in drinking water. Significant body weight gain depressions were observed in all treated males, and there was an absolute weight loss in the 4% male group, none of which survived to the end of the study. Except for the 4% dose group, there was a treatment-related increase in hyaline droplet accumulation in the renal proximal tubules with crystalline, rectangular, and rhomboid forms of the protein evident. The severity of nephropathy was enhanced in treated rats, except for the 4% dose group. Replicative DNA synthesis, as measured by immunohistochemical staining for proliferating cell nuclear antigen, was increased in proximal tubules of rats dosed with 2% t-butyl alcohol. It is concluded that tbutyl alcohol exacerbated nephropathy in male Fischer 344 rats and increased renal accumulation of hyaline protein material consistent with a-2p-globulin deposition.

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“…Drinking water 0, 0.25, 0.5, 1, 2 or 4 %, equivalent to 0, 625, 1250, 2500, 5000 or 10,000 mg/kg bw/day 90 days Male: 1 %, equivalent to 2500 mg/kg bw/day Female: 2 %, equivalent to 5000 mg/kg bw/day (Lindamood et al, 1992;NTP, 1995b) Fully described NTP study.…”

Section: Mouse; M F 20mentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 18, Revision 2 (FGE.18Rev2): Aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters from chemical groups 6 and 8

Flavourings¹

2011

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 32 flavouring substances in the Flavouring Group Evaluation 18, Revision 2, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that 28 substances 02.052, 02.054, 02.120, 02.123, 02.129, 02.140, 02.144, 02.147, 02.149, 02.150, 02.168, 02.171, 02.181, 02.184, 02.197, 02.203, 02.206, 02.219, 02.226, 02.230, 02.253, 09.171, 09.356, 09.614, 09.617, 09.671 and 09.808] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining four substances 02.185, 02.191 and 09.669] no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for six substances information is lacking. The present Flavouring Group Evaluation deals with 32 saturated and unsaturated aliphatic acyclic and alicyclic tertiary alcohols, aromatic tertiary alcohols and their esters. Based on their structures, the candidate substances can be subdivided into 8 subgroups.Nineteen of the 32 candidate substances possess one or more chiral centres and/or can exist as geometrical stereoisomers due to the presence of a double bond: 02.129, 02.140, 02.144, 02.146, 02.147, 02.149, 02.150, 02.168, 02.191, 02.197, 02.206, 02.226, 02.230, 02.253, 09.171, 09.614, 09.671 and 09.808]. For five of these substances 02.147, 02.168, 02.191 and 02.197] the stereoisomeric composition has not been specified sufficiently. For four of these five substances 02.168, 02.191 and 02.197] the stereoisomeric composition of the mixture has not been specified.Twenty of the 32 candidate substances are classified into structural class I, 11 candidate substances are classified into structural class II and one is classified into structural class III according to the decision tree approach.Twenty-four out of the 32 candidate substances have been reported to occur in a wide range of food items.In its evaluation, the Panel as a default used the Maximised Survey-derived Daily Intake (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavouring Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. In conse...

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Subchronic Toxicity Studies of t-Butyl Alcohol in Rats and Mice

Cited by 14 publications

References 0 publications

Toxic Alcohols: Aliphatic Saturated Alcohols

Toxic Alcohols: Aliphatic Saturated Alcohols

Retrospective study of possible alpha-2 mu-globulin nephropathy and associated cell proliferation in male Fischer 344 rats dosed with t-butyl alcohol.

Scientific Opinion on Flavouring Group Evaluation 18, Revision 2 (FGE.18Rev2): Aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters from chemical groups 6 and 8

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