Triethylene Glycol Ethers: Evaluations of In Vitro Absorption Through Human Epidermis, 21-Day Dermal Toxicity in Rabbits, and a Developmental Toxicity Screen in Rats

Leber, A. Philip; Scott, Robert C.; Hodge, M.C.E.; Johnson, Debra; Krasavage, Walter J.

doi:10.3109/10915819009078759

Cited by 15 publications

(13 citation statements)

References 26 publications

(1 reference statement)

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“…Loeser and Lorke (1976a): The death of 3 male rats, one in each dose group (1, 3, and 30 ppm), which the authors of the study could not establish a connection to the treatment for, was reported as "no effects" in the study summary. Leber et al (1990): In the study, focal testicular degeneration was observed "to a slight degree in 1 rabbit in each of the TM (unilateral) and TE (bilateral) groups." The authors of the study stated that this lesion can appear spontaneously in the species tested.…”

Section: Appropriate Reflection Of Informationmentioning

confidence: 89%

“…The study summary focused on one of the tests but the registrant also included results from another test that used different doses and exposure time. Leber et al (1990): Three similar substances, including the substance registered in the dossier, were tested. The registrant also reported results for one of the substances similar to the test substance without making this clear in the study summary.…”

Section: Differences In Conclusionmentioning

confidence: 99%

“…For the studies by Ballantyne et al (2006), Gaunt et al (1968), Leber et al (1990), and Maltoni et al (1986), for which certain conclusions and/or results were not reported in the study summaries, the reason for not reporting this information is unclear.…”

Section: Omission Of Information On Study Designmentioning

confidence: 99%

“…Summarizing and rephrasing data also puts high demands on the registrants to unambiguously report data in the study summaries. Any unclear reporting as seen in the studies by Ballantyne et al (2006), Barnes and Stoner (1958), and Leber et al (1990) will not be revealed unless one goes back to the full study report. However, this report might not be publicly available and, due to time constraints, not discovered.…”

Section: Appropriate Reflection Of Informationmentioning

confidence: 99%

“…The registrant did not mention in the study summary that damage to the bile duct had been observed in previous studies and could have been overlooked in this study due to too-short exposure duration. Leber et al (1990): The study investigated systemic toxicity through dermal exposure and also included a dermal penetration test. The authors concluded that the tested substances "did not produce systemic toxicity.…”

Section: Appropriate Reflection Of Informationmentioning

confidence: 99%

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Toxicity studies used in registration, evaluation, authorisation and restriction of chemicals (REACH): How accurately are they reported?

Ingre-Khans

Ågerstrand²,

Beronius

et al. 2019

Integr Envir Assess & Manag

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Toxicity studies on chemicals registered under the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation are provided as summaries instead of as a full study report. Because the registration data are used by regulatory agencies to identify chemicals of concern, the study summaries must accurately reflect the information in studies. A “study summary” should include sufficient information on the objectives, methods, results, and conclusions in the full study report in order for the relevance of the study to be determined. Sometimes a “robust study summary” is required, which should contain more detailed information to enable an independent assessment of the study. The aim of the present investigation is to examine how well published toxicity papers were reflected in study summaries submitted by registrants under REACH. Summaries of 20 published studies (peer‐reviewed studies, including 1 abstract) were examined and broad categories of various types of observed differences were derived. The extent to which information in the published studies was reported, as well as how accurately the information was reflected, varied. How accurately the information was reflected also varied. Differences between the published studies and the summaries included simple typing errors, unclear and incomplete reporting, as well as the omission of information on, for example, study design, results, or interpretation of the results, which in some cases could be considered relevant for the risk assessment. This raises concerns regarding the accuracy of study summaries and their use for decision making. Moreover, the possibility for third parties to independently assess and scrutinize the summaries is limited. Considering that we rely on REACH registration data for chemical safety, all data used for risk assessment should be accessible for thorough examination and fully independent assessment. Integr Environ Assess Manag 2019;00:000–000. © 2019 SETAC

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Section: Appropriate Reflection Of Informationmentioning

confidence: 89%

Section: Differences In Conclusionmentioning

confidence: 99%

Section: Omission Of Information On Study Designmentioning

confidence: 99%

Section: Appropriate Reflection Of Informationmentioning

confidence: 99%

Section: Appropriate Reflection Of Informationmentioning

confidence: 99%

See 3 more Smart Citations

Toxicity studies used in registration, evaluation, authorisation and restriction of chemicals (REACH): How accurately are they reported?

Ingre-Khans

Ågerstrand²,

Beronius

et al. 2019

Integr Envir Assess & Manag

View full text Add to dashboard Cite

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Ethers of Ethylene Glycol and Derivatives

Kelsey

2023

Patty's Toxicology

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E series Glycol ethers are alkyl ethers of ethylene glycol along with their acetate esters. They are commonly used in paints and cleaners and typically have a higher boiling point in conjunction with the favorable solvent properties of lower‐molecular weight ethers, esters, and alcohols. They are colorless liquids that have mild earthy or fruity odors. The ethers are miscible with water and/or with numerous organic solvents making them useful as solvents in oil‐water compositions. Their relatively slow rate of evaporation also makes them useful as solvents and coalescing agents in paints and inks. The surface tension and solvent properties of the ethers make them useful in cleaners. Other uses of the ethers include process solvents and deicers. The ethers of the higher glycols are used as hydraulic fluids. Occupational exposure to glycol ethers occurs dermally and by inhalation. Most glycol ethers have low acute, single‐dose toxicity to humans. The most notable and well‐known effect relevant to humans is toxicity to male fertility and developmental toxicity produced by those glycol ethers that can metabolize to produce significant amounts of methoxyacetic acid such as methoxy ethanol and the methyl glymes.

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Ethers of Ethylene Glycol and Derivatives

Boatman¹,

Knaak²

2001

Patty's Toxicology

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There are currently seven U.S. manufacturers of ethers and other derivatives of ethylene glycol (EG), diethylene glycol (DEG), and higher glycols. Five of them are members of the American Chemistry Council (ACC) Glycol Ethers' Panel. The glycol ethers most commonly encountered industrially are colorless liquids that have mild ethereal odors. Alkyl glycol ethers are manufactured in a closed, continuous process by reacting ethylene oxide with an anhydrous alcohol in the presence of a suitable catalyst. Depending on the molar ratios of the reactants and other process parameters, the product mixtures obtained contain varying amounts of the monoethylene‐, diethylene‐, triethylene‐, and higher glycol ethers. Typically, the products in these mixtures are separated and purified by fractional distillation. The miscibility of most of these ethers with water and with a large number of organic solvents makes them especially useful as solvents in oil–water compositions. Their relatively slow rate of evaporation also makes them useful as solvents and coalescing agents in paints. Other uses include inks, cleaners, chemical intermediates, process solvents, brake fluids, and deicers. The ethers of the higher glycols are used as hydraulic fluids. An estimate of the U.S. production and use of representative ethylene glycol ethers is presented. Production of ethylene glycol ethers (total) in Western Europe amounted to 245 thousand metric tons in 1995. Occupational exposure to glycol ethers occurs dermally and by inhalation. Ingestion is not a concern in industrial exposure, although some cases of intentional ingestion of consumer products containing ethylene glycol ethers have been reported. A number of analytical methods have been published that are suitable for detecting glycol ethers in environmental air samples. Glycol ethers generally have low acute, single‐dose toxicity, and LD 50 values generally range from 1.0 to 4.0 g/kg of body weight. In animals and humans, high‐dose administrations (>350 mg/kg) result in central nervous system depression, although the results from many studies show no specific damage to neural tissues. Other toxicological effects attributable to glycol ethers are associated with metabolism to the corresponding alkoxyacetic acids. In the case of EGME, EGEE, and certain other glycol ether derivatives, significant reproductive, developmental, hematologic, and immunologic effects have been associated with the formation of either methoxyacetic (MAA) or ethoxyacetic acids (EAA). For other glycol ether derivatives substituted with propyl, butyl, or higher homologues, developmental effects secondary to maternal toxicity (without teratogenic effects), as well as hematologic effects, are observed. Ethylene glycol ethers and acetates may enter the environment from manufacturing effluents and emissions and as a result of their use in commercial products.

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Triethylene Glycol Ethers: Evaluations of In Vitro Absorption Through Human Epidermis, 21-Day Dermal Toxicity in Rabbits, and a Developmental Toxicity Screen in Rats

Cited by 15 publications

References 26 publications

Toxicity studies used in registration, evaluation, authorisation and restriction of chemicals (REACH): How accurately are they reported?

Toxicity studies used in registration, evaluation, authorisation and restriction of chemicals (REACH): How accurately are they reported?

Ethers of Ethylene Glycol and Derivatives

Ethers of Ethylene Glycol and Derivatives

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