Acute toxicity and cancer risk assessment values for tert-butyl acetate

Budroe, John D.; Brown, Joseph P.; Salsmon, Andrew G.; Marty, Melanie A.

doi:10.1016/j.yrtph.2004.07.001

Cited by 11 publications

(19 citation statements)

References 19 publications

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“…A 13-week butyl acetate rat inhalation study also demonstrated decreased body weight, feed consumption, liver, kidney, and spleen weights at concentrations of ≥ 1500 ppm for male rats (David et al, 2001). Acute toxicity and cancer risk assessment for butyl acetate suggest it is a potential carcinogen (Budroe et al, 2004). Limited toxicity data (LD 50 rats = 11.3 g/kg) was found for ethyl acetate.…”

Section: Discussionmentioning

confidence: 98%

Immunotoxicity and allergic potential induced by topical application of dimethyl carbonate (DMC) in a murine model

Anderson

Franko

Anderson

et al. 2012

Journal of Immunotoxicology

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Section: Discussionmentioning

confidence: 98%

Immunotoxicity and allergic potential induced by topical application of dimethyl carbonate (DMC) in a murine model

Anderson

Franko

Anderson

et al. 2012

Journal of Immunotoxicology

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“…According to Budroe et al [1], the IBT study reported an LC 50 of 281 ppm, while Stillmeadow reported the LC 50 to be greater than 470 ppm, the highest concentration tested. Deaths from exposures to TBAC below 400 ppm have not been confirmed in four independent studies: (1) Groth and Freundt [17] -no deaths at 440 ppm for 5 h or 900 ppm for 4 h; (2) Stillmeadow [16] -no deaths at 470 ppm; (3) current metabolism study -no deaths at 1000 ppm; (4) current acute inhalation study -no deaths at 1873 ppm.…”

Section: Acute and Subacute Toxicity Of Tbacmentioning

confidence: 96%

“…The present publication includes an acute inhalation study in rats conducted using the most current guidelines and conducted according to GLPs; it included a control group and estimated an LC 50 of 4200 ppm and reported clinical signs at 1873 ppm within the first hour after exposure, but not the following day. Recently, Budroe et al [1] published an assessment of the acute toxicity and cancer risk assessment for TBAC; they asserted that a 1958 acute inhalation study by Industrial Biotest Laboratories, Inc. (IBT) [15] should be used to calculate an acute reference level, rather than a study conducted according to current guidelines and GLPs by Stillmeadow Inc. (1997) [16] because the more recent study did not include a control group and the older study reported effects at lower concentrations.…”

Section: Acute and Subacute Toxicity Of Tbacmentioning

confidence: 99%

“…5. Budroe et al [1] miscalculated the LC 50 and Lowest-Observed-Adverse-Effect Level (LOAEL) from the IBT study; as reported in the IBT final report, the LC 50 was 13,300 mg m À3 (2810 ppm) and the LOAEL was 5000 mg m À3 .…”

Section: Acute and Subacute Toxicity Of Tbacmentioning

confidence: 99%

“…As recently reviewed Budroe et al [1], TBAC is not very toxic following acute exposures; however, toxicity following repeated exposure has not been evaluated. They reviewed the metabolic data on TBAC and estimated TBAC potency based on 100% metabolism of TBAC to tertiary-butyl alcohol (TBA).…”

Section: Introductionmentioning

confidence: 99%

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Tertiary-butyl acetate metabolism, toxicity, and human health considerations

Cruzan

Kirkpatrick

2006

Toxicological & Environmental Chemistry

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Tertiary-butyl acetate (TBAC) is an organic solvent with a potential for occupational and environmental exposure as a result of its use in industrial coatings, adhesives, inks, and degreasers. The objective of these studies was to extend the toxicological database upon which health hazard and risk assessments of TBAC can be made. The metabolism of TBAC was studied in rats exposed by inhalation for 6 h to concentrations of 100 or 1000 ppm. There was an evidence of partial saturation of TBAC absorption and metabolism at some concentration below 1000 ppm. Approximately 5% of the low dose and 26% of the high dose was expired without change within 12 h, while the retained material was rapidly metabolised and excreted, mostly in the urine, within 24 h. Very little radioactivity remained in the tissues after day 7. The metabolism of TBAC appears to follow two major routes: hydroxylation of the tertiary-butyl moiety to form 2-hydroxymethylisopropyl acetate and ester hydrolysis to form tertiary-butyl alcohol (TBA). A minor route involves oxidation of the acetate moiety. Based on the proportion of metabolites that can clearly be assigned to one or the other major pathway, hydroxylation of the tertiary-butyl moiety prevails at 100 ppm, while hydrolysis of the ester bond predominates at 1000 ppm.Based on nose-only inhalation exposure of rats to TBAC for 6 h, the LC50 for males and females combined is approximately 4200 ppm. Clinical signs included exaggerated breathing, staggering, tremors, and lethargy approximately 1 h after the exposure, but all surviving rats appeared normal from 24 h until the end of the 14 day observation period. An LC 50 was not identified for mice. After exposure of whole body for 6 h to 3000 ppm, the highest concentration tested, all mice were prostrate for most of the exposure time, but there were no deaths.Groups of five male and five female Sprague-Dawley rats were exposed nose-only to 0, 100, 400, or 1600 ppm TBAC 6 h day À1 5 days wk À1 for 2 weeks. There were no effects on body weight, feed or water consumption, or necropsy findings. Male rats exposed to 1600 ppm had increased liver weights and hypertrophy of centrilobular hepatocytes. An increased proportion of cortical tubule cells with hyaline droplet accumulation was observed in all treated groups of males. Groups of five male and five female CD-1 mice were exposed whole body to 0, 190, 375, 750, or 1500 ppm TBAC 6 h day À1 for 14 consecutive days. There were no effects on body weight, feed consumption, or necropsy findings. Liver weights were increased in female mice at 750 and 1500 ppm. Minimal hypertrophy of centrilobular hepatocytes was found in female mice at 375, 750, and 1500 ppm and in male mice at 1500 ppm TBAC.TBAC did not induce gene mutations in bacterial tests with strains of S. typhimurium and E. coli. Further, there was no evidence of clastogenic activity from tests either for the induction of chromosomal aberrations in human lymphocytes in vitro in the presence or absence of S9 mix or for the induction of micronuclei in bo...

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Effects of tert–butyl acetate on maternal toxicity and embryo‐fetal development in Sprague‐Dawley rats

Yang¹,

Ahn²,

Lee³

et al. 2007

Birth Defects Research Pt B

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This study investigated the potential adverse effects of tert-butyl acetate (TBAc) on maternal toxicity and embryo-fetal development after maternal exposure of pregnant rats from gestational days 6 through 19. TBAc was administered to pregnant rats by gavage at 0, 400, 800, and 1,600 mg/kg/day. All dams were subjected to a Caesarean section on day 20 of gestation, and their fetuses were examined for any morphological abnormalities. At 1,600 mg/kg, maternal toxicity manifested as increases in the incidence of clinical signs and death, lower body weight gain and food intake, increases in the weights of adrenal glands and liver, and a decrease in thymus weight. Developmental toxicity included a decrease in fetal weight, an increase in the incidence of skeletal variation, and a delay in fetal ossification. At 800 mg/kg, only a minimal developmental toxicity, including an increase in the incidence of skeletal variation and a delay in fetal ossification, were observed. In contrast, no adverse maternal or developmental effects were observed at 400 mg/kg. These results show that a 14-day repeated oral dose of TBAc is embryotoxic at a maternally toxic dose (i.e., 1,600 mg/kg/day) and is minimally embryotoxic at a nonmaternally toxic dose (i.e., 800 mg/kg/day) in rats. However, no evidence for the teratogenicity of TBAc was noted in rats. It is concluded that the developmental findings observed in the present study are secondary effects to maternal toxicity. Under these experimental conditions, the no-observed-adverse-effect level of TBAc is considered to be 800 mg/kg/day for dams and 400 mg/kg/day for embryo-fetal development.

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Acute toxicity and cancer risk assessment values for tert-butyl acetate

Cited by 11 publications

References 19 publications

Immunotoxicity and allergic potential induced by topical application of dimethyl carbonate (DMC) in a murine model

Immunotoxicity and allergic potential induced by topical application of dimethyl carbonate (DMC) in a murine model

Tertiary-butyl acetate metabolism, toxicity, and human health considerations

Effects of tert–butyl acetate on maternal toxicity and embryo‐fetal development in Sprague‐Dawley rats

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