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Assessment of perfluorocarboxylic acids in fluorinated high-density polyethylene containers and estimation of potential non-cancer risks associated with anticipated use scenarios
This study measured the amounts of PFCAs that may be present in the fluorinated HDPE containers, which could migrate into products stored in these containers. Migration studies were also conducted using water and mineral spirits to estimate the amount of PFCAs that might be found in the products stored in these containers. The migration results were used to conservatively model potential PFCA exposures from use of six product types: indoor-sprayed products, floor products, hand-applied products, manually-sprayed pesticides, hose-end sprayed products, and agricultural (industrial) pesticides. The potential that such uses co...
Source: Regulatory Toxicology and Pharmacology : RTP - January 5, 2024 Category: Toxicology Authors: LeeAnn Racz Alison Gauthier Jennifer Bare Melissa Heintz David Feifarek Stephanie Kennedy Julie Panko Source Type: research

Examining animal testing for risk assessment: A WC-12 workshop report
Regul Toxicol Pharmacol. 2024 Jan 3:105564. doi: 10.1016/j.yrtph.2024.105564. Online ahead of print.ABSTRACTIn toxicology and regulatory testing, the use of animal methods has been both a cornerstone and a subject of intense debate. To continue this discourse a panel and audience representing scientists from various sectors and countries convened at a workshop held during the 12th World Congress on Alternatives and Animal Use in the Life Sciences (WC-12). The ensuing discussion focused on the scientific and ethical considerations surrounding the necessity and responsibility of defending the creation of new animal data in r...
Source: Regulatory Toxicology and Pharmacology : RTP - January 5, 2024 Category: Toxicology Authors: Yadvinder Bhuller Agnes Karmaus Nicole Kleinstreuer Troy Seidle Harald Schlatter Michael Wade P Charukeshi Chandrasekera Source Type: research

Assessment of perfluorocarboxylic acids in fluorinated high-density polyethylene containers and estimation of potential non-cancer risks associated with anticipated use scenarios
This study measured the amounts of PFCAs that may be present in the fluorinated HDPE containers, which could migrate into products stored in these containers. Migration studies were also conducted using water and mineral spirits to estimate the amount of PFCAs that might be found in the products stored in these containers. The migration results were used to conservatively model potential PFCA exposures from use of six product types: indoor-sprayed products, floor products, hand-applied products, manually-sprayed pesticides, hose-end sprayed products, and agricultural (industrial) pesticides. The potential that such uses co...
Source: Regulatory Toxicology and Pharmacology : RTP - January 5, 2024 Category: Toxicology Authors: LeeAnn Racz Alison Gauthier Jennifer Bare Melissa Heintz David Feifarek Stephanie Kennedy Julie Panko Source Type: research

Corrigendum to "Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products" [Regul. Toxicol. Pharmacol. 72 3 (2015) 673-68]
Regul Toxicol Pharmacol. 2024 Jan 3:105545. doi: 10.1016/j.yrtph.2023.105545. Online ahead of print.NO ABSTRACTPMID:38177031 | DOI:10.1016/j.yrtph.2023.105545 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - January 4, 2024 Category: Toxicology Authors: B Safford A M Api C Barratt D Comiskey E J Daly G Ellis C McNamara C O'Mahony S Robison B Smith R Thomas S Tozer Source Type: research

Corrigendum to "Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products" [Regul. Toxicol. Pharmacol. 72 3 (2015) 673-68]
Regul Toxicol Pharmacol. 2024 Jan 3:105545. doi: 10.1016/j.yrtph.2023.105545. Online ahead of print.NO ABSTRACTPMID:38177031 | DOI:10.1016/j.yrtph.2023.105545 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - January 4, 2024 Category: Toxicology Authors: B Safford A M Api C Barratt D Comiskey E J Daly G Ellis C McNamara C O'Mahony S Robison B Smith R Thomas S Tozer Source Type: research

Are current regulatory log K < sub > ow < /sub > cut-off values fit-for-purpose as a screening tool for bioaccumulation potential in aquatic organisms?
In this study, the experimentally determined log Kow and fish bioconcentration factors (BCF) of 532 chemicals were compared. While the analysis underlined the robustness of using log Kow as a screening tool (5/532 were false negatives; log Kow: non-bioaccumulative, but BCF: bioaccumulative), it also demonstrated the conservatism of the cut-offs used worldwide. Indeed, many chemicals were deemed potentially Bioaccumulative based on log Kow when a fish bioaccumulation test showed no concern (false positives), therefore, leading to unnecessary use of vertebrate animals. Our analysis shows that the log Kow cut-off could be inc...
Source: Regulatory Toxicology and Pharmacology : RTP - December 29, 2023 Category: Toxicology Authors: Sylvia Gimeno Dawn Allan Paul Kai Pauline Remuzat Marie Collard Source Type: research

Safety considerations for dietary supplement manufacturers in the United States
Regul Toxicol Pharmacol. 2023 Dec 27;147:105544. doi: 10.1016/j.yrtph.2023.105544. Online ahead of print.ABSTRACTDue to significant dietary supplement use in the US, product manufacturers must understand the importance of implementing a robust approach to establishing safety for all ingredients, including dietary ingredients, components, and finished dietary supplement products. Different regulatory pathways exist by which the safety of dietary ingredients can be established, and thus allowed to be marketed in a dietary supplement. For individual dietary ingredients, safety information may come from a variety of sources in...
Source: Regulatory Toxicology and Pharmacology : RTP - December 29, 2023 Category: Toxicology Authors: Jay Sirois Sudheer Reddy Tony Nguyen Heather Walker Jessica Rendall Georges Bergen Mark Reimers Erica Cermak Asheesh Tiwary Emily Helmes Jennifer Palmer Steve Teo Tami Mackle Mimi Park Charlene Wang Source Type: research

Are current regulatory log K < sub > ow < /sub > cut-off values fit-for-purpose as a screening tool for bioaccumulation potential in aquatic organisms?
In this study, the experimentally determined log Kow and fish bioconcentration factors (BCF) of 532 chemicals were compared. While the analysis underlined the robustness of using log Kow as a screening tool (5/532 were false negatives; log Kow: non-bioaccumulative, but BCF: bioaccumulative), it also demonstrated the conservatism of the cut-offs used worldwide. Indeed, many chemicals were deemed potentially Bioaccumulative based on log Kow when a fish bioaccumulation test showed no concern (false positives), therefore, leading to unnecessary use of vertebrate animals. Our analysis shows that the log Kow cut-off could be inc...
Source: Regulatory Toxicology and Pharmacology : RTP - December 29, 2023 Category: Toxicology Authors: Sylvia Gimeno Dawn Allan Paul Kai Pauline Remuzat Marie Collard Source Type: research

Safety considerations for dietary supplement manufacturers in the United States
Regul Toxicol Pharmacol. 2023 Dec 27:105544. doi: 10.1016/j.yrtph.2023.105544. Online ahead of print.ABSTRACTDue to significant dietary supplement use in the US, product manufacturers must understand the importance of implementing a robust approach to establishing safety for all ingredients, including dietary ingredients, components, and finished dietary supplement products. Different regulatory pathways exist by which the safety of dietary ingredients can be established, and thus allowed to be marketed in a dietary supplement. For individual dietary ingredients, safety information may come from a variety of sources includ...
Source: Regulatory Toxicology and Pharmacology : RTP - December 29, 2023 Category: Toxicology Authors: Jay Sirois Sudheer Reddy Tony Nguyen Heather Walker Jessica Rendall Georges Bergen Mark Reimers Erica Cermak Asheesh Tiwary Emily Helmes Jennifer Palmer Steve Teo Tami Mackle Mimi Park Charlene Wang Source Type: research

Are current regulatory log K < sub > ow < /sub > cut-off values fit-for-purpose as a screening tool for bioaccumulation potential in aquatic organisms?
In this study, the experimentally determined log Kow and fish bioconcentration factors (BCF) of 532 chemicals were compared. While the analysis underlined the robustness of using log Kow as a screening tool (5/532 were false negatives; log Kow: non-bioaccumulative, but BCF: bioaccumulative), it also demonstrated the conservatism of the cut-offs used worldwide. Indeed, many chemicals were deemed potentially Bioaccumulative based on log Kow when a fish bioaccumulation test showed no concern (false positives), therefore, leading to unnecessary use of vertebrate animals. Our analysis shows that the log Kow cut-off could be inc...
Source: Regulatory Toxicology and Pharmacology : RTP - December 29, 2023 Category: Toxicology Authors: Sylvia Gimeno Dawn Allan Paul Kai Pauline Remuzat Marie Collard Source Type: research

Safety considerations for dietary supplement manufacturers in the United States
Regul Toxicol Pharmacol. 2023 Dec 27:105544. doi: 10.1016/j.yrtph.2023.105544. Online ahead of print.ABSTRACTDue to significant dietary supplement use in the US, product manufacturers must understand the importance of implementing a robust approach to establishing safety for all ingredients, including dietary ingredients, components, and finished dietary supplement products. Different regulatory pathways exist by which the safety of dietary ingredients can be established, and thus allowed to be marketed in a dietary supplement. For individual dietary ingredients, safety information may come from a variety of sources includ...
Source: Regulatory Toxicology and Pharmacology : RTP - December 29, 2023 Category: Toxicology Authors: Jay Sirois Sudheer Reddy Tony Nguyen Heather Walker Jessica Rendall Georges Bergen Mark Reimers Erica Cermak Asheesh Tiwary Emily Helmes Jennifer Palmer Steve Teo Tami Mackle Mimi Park Charlene Wang Source Type: research

Ninety-day toxicity and genotoxic effects of synthetically derived fully saturated forms of anacardic acid in mice
In this study, organically synthesized fully saturated form of AA was orally administered to male and female Swiss albino mice for 90 consecutive days at doses of 25, 50 and 100 mg/kg BW (n = 20 per sex/group). Administration of AA was well tolerated at all dose levels. The treated animals did not show a dose-response toxicity in their hematology, liver, or metabolic profile. Minimally significant changes in serum biochemistry and hematology parameters were noted, but these were not considered to be of biological or toxicological importance and were not outside the known accepted ranges. Sporadic differences in organ weigh...
Source: Regulatory Toxicology and Pharmacology : RTP - December 27, 2023 Category: Toxicology Authors: S Sriram M Sai Kumar G K Shourie A Palukurthi S Kadam T M Srikanth Source Type: research

Ninety-day toxicity and genotoxic effects of synthetically derived fully saturated forms of anacardic acid in mice
In this study, organically synthesized fully saturated form of AA was orally administered to male and female Swiss albino mice for 90 consecutive days at doses of 25, 50 and 100 mg/kg BW (n = 20 per sex/group). Administration of AA was well tolerated at all dose levels. The treated animals did not show a dose-response toxicity in their hematology, liver, or metabolic profile. Minimally significant changes in serum biochemistry and hematology parameters were noted, but these were not considered to be of biological or toxicological importance and were not outside the known accepted ranges. Sporadic differences in organ weigh...
Source: Regulatory Toxicology and Pharmacology : RTP - December 27, 2023 Category: Toxicology Authors: S Sriram M Sai Kumar G K Shourie A Palukurthi S Kadam T M Srikanth Source Type: research

Ninety-day toxicity and genotoxic effects of synthetically derived fully saturated forms of anacardic acid in mice
In this study, organically synthesized fully saturated form of AA was orally administered to male and female Swiss albino mice for 90 consecutive days at doses of 25, 50 and 100 mg/kg BW (n = 20 per sex/group). Administration of AA was well tolerated at all dose levels. The treated animals did not show a dose-response toxicity in their hematology, liver, or metabolic profile. Minimally significant changes in serum biochemistry and hematology parameters were noted, but these were not considered to be of biological or toxicological importance and were not outside the known accepted ranges. Sporadic differences in organ weigh...
Source: Regulatory Toxicology and Pharmacology : RTP - December 27, 2023 Category: Toxicology Authors: S Sriram M Sai Kumar G K Shourie A Palukurthi S Kadam T M Srikanth Source Type: research

Ninety-day toxicity and genotoxic effects of synthetically derived fully saturated forms of anacardic acid in mice
In this study, organically synthesized fully saturated form of AA was orally administered to male and female Swiss albino mice for 90 consecutive days at doses of 25, 50 and 100 mg/kg BW (n = 20 per sex/group). Administration of AA was well tolerated at all dose levels. The treated animals did not show a dose-response toxicity in their hematology, liver, or metabolic profile. Minimally significant changes in serum biochemistry and hematology parameters were noted, but these were not considered to be of biological or toxicological importance and were not outside the known accepted ranges. Sporadic differences in organ weigh...
Source: Regulatory Toxicology and Pharmacology : RTP - December 27, 2023 Category: Toxicology Authors: S Sriram M Sai Kumar G K Shourie A Palukurthi S Kadam T M Srikanth Source Type: research