Results of Testing Fifteen Glycol Ethers in a Short-Term in Vivo Reproductive Toxicity Assay

Schuler, Ronald L.; Hardin, Bryan D.; Niemeier, Richard W.; Booth, Gary M.; Hazelden, Keith P.; Piccirillo, Vincent J.; Smith, Kirby D.

doi:10.2307/3429910

Cited by 15 publications

(13 citation statements)

References 1 publication

(2 reference statements)

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“…The EFSA Journal (2009) 934, 76-114 (Moreno, 1978f) Octane-1,3-diol [02.198] Rat NR Oral > 20000 (Frankenfeld et al, 1975) (3,7-Dimethyloctane-1,7-diol [02.047]) Rat M, F Gavage > 5000 (Levenstein, 1973b) (1,1-Dimethoxy-3,7-dimethyloctan-7-ol [06.011]) Rat NR Oral > 5000 (Shelanski & Moldovan, 1973a) (Hardin et al, 1987;Schuler et al, 1984;Smith, 1983) FGE.10 refers to (EPA, 1999 (Slesinski et al, 1983) Lack of mutagenic activity considered to be due to reaction of glutaraldehyde with proteins in cell membrane, cytosol…”

Section: Annex Iv: Toxicitymentioning

confidence: 99%

Flavouring Group Evaluation 10, Revision 1 (FGE10 Rev1) - Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical g

2009

EFSA Journal

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Section: Annex Iv: Toxicitymentioning

confidence: 99%

Flavouring Group Evaluation 10, Revision 1 (FGE10 Rev1) - Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical g

2009

EFSA Journal

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“…DGBE is not mutagenic or genotoxic [15]. No embryotoxic or fetotoxic effects were noted in mice receiving the substance during organogenesis or in rats receiving it throughout the pregnancy [16,17]. This study was intended to evaluate the effects of DGBE, given orally on the estrous cycle in female rats, and administered with drinking water on the fertility of male and female rats.…”

Section: Estrous Cyclicitymentioning

confidence: 99%

Fertility and developmental toxicity studies of diethylene glycol monobutyl ether (DGBE) in rats

Sitarek¹,

Gromadzińska²,

Lutz³

et al. 2012

International Journal of Occupational Medicine and Environmental Health

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Objectives: The solvent, dimethylene glycol monobutyl ether (DGBE), is a component of latex paints, inks; it is used as a degreasing agent, industrial detergent. The aim of the study was evaluating the effects of DGBE administered by gavage on the estrous cycle and given with drinking water on fertility in rats and early development of their progeny. Materials and Methods: Female rats were exposed to DGBE by gavage during 8 weeks at 250, 500 or 1000 mg/kg/day. Vaginal smears were collected during the exposure and 4 weeks after its cessation. Fertility studies were performed in male and female animals exposed to in drinking water. Males were exposed for 10 weeks and then mated with females exposed before mating, during pregnancy and lactation. Young animals were observed during 3 weeks after birth. Results: DGBE does not cause disturbances of the menstrual cycle in females. Parameters used to assess the general toxicity indicate that males receiving DGBE in drinking water are more sensitive to this compound than females: significantly greater, dose-dependent relative spleen weight, significant decrease in hematological parameters from 8% to 15% depending on the dose, were observed. Clinical chemistry parameters (HDL-cholesterol, BUN) and some markers of oxidative stress differ between the exposed groups and the control one, but without adverse health effect. The microscopic examination of internal organs did not reveal morphological changes in male and female rats. Conclusion: The results of our study on the impact of exposure to DGBE on fertility in rats indicate that the substance administered for 9-10 weeks to females and males at a limit dose of 1000 mg/kg did not impair fertility or viability of their offspring during the first three weeks of life.

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“…The supporting and structurally related substances are listed in brackets. (Gulati et al, 1985b;Heindel et al, 1990) FGE.10 refers to (EPA, 1999;EU-RAR, 2004a (1000 mg/kg/day) (Gulati et al, 1985b;Heindel et al, 1990) FGE.10 refers to (EPA, 1999;EU-RAR, 2004a (Gulati et al, 1985b;Heindel et al, 1990) FGE.10 refers to (EPA, 1999;EU-RAR, 2004a (Gulati et al, 1985b;Heindel et al, 1990) FGE.10 refers to (EPA, 1999;EU-RAR, 2004a (Hardin et al, 1987;Schuler et al, 1984;Smith, 1983) FGE.10 refers to (EPA, 1999;EU-RAR, 2004a 2 Dose range-finding phase: Based on the results of this dose range-finding study the highest concentration investigated further was 2 % in the drinking water.…”

Section: Annex Iv: Toxicitymentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 10, Revision 3 (FGE.10Rev3): Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30

Flavourings¹

2012

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 63 flavouring substances in the Flavouring Group Evaluation 10, including additional two substances in this Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. For one substance .170] a concern for genotoxicity could not be ruled out. The remaining 62 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 the 62 substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For four substances evaluated through the Procedure, the stereoisomeric composition has not been specified sufficiently. The flavouring substances are alcohols, aldehydes, acetals, carboxylic acids and esters containing additional oxygenated functional groups and lactones. © European FoodThirty-six of the candidate substances possess one or more chiral centres and eight can exist as geometrical isomers due to the presence and the position of a double bond. For five of these substances 10.040, 10.059, 10.063 and 10.170] the stereoisomeric composition / composition of mixture has not been specified sufficiently.Fifty-five candidate substances belong to structural class I, six belong to structural class II, and two belong to structural class III according to the decision tree approach presented by Cramer et al. (1978).Fifty of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intakes" (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 consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a "modified Theoretical Added Maximum Daily Intake" (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated th...

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Results of Testing Fifteen Glycol Ethers in a Short-Term in Vivo Reproductive Toxicity Assay

Cited by 15 publications

References 1 publication

Flavouring Group Evaluation 10, Revision 1 (FGE10 Rev1) - Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical g

Flavouring Group Evaluation 10, Revision 1 (FGE10 Rev1) - Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical g

Fertility and developmental toxicity studies of diethylene glycol monobutyl ether (DGBE) in rats

Scientific Opinion on Flavouring Group Evaluation 10, Revision 3 (FGE.10Rev3): Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30

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