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Article ; Online: A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals.

Aggarwal, Manoj / Chikwana, Edward / Corvaro, Marco

Regulatory toxicology and pharmacology : RTP

2022 Volume 135, Page(s) 105250

Abstract: Phototoxicity testing is required by European regulations for agrochemicals with UV/visible molar extinction/absorption coefficient (MEC) higher than 10 L x ... ...

Abstract	Phototoxicity testing is required by European regulations for agrochemicals with UV/visible molar extinction/absorption coefficient (MEC) higher than 10 L x mol
MeSH term(s)	Agrochemicals/toxicity ; Dermatitis, Phototoxic/etiology ; Herbicides ; Humans ; Risk Assessment ; Skin
Chemical Substances	Agrochemicals ; Herbicides
Language	English
Publishing date	2022-08-23
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2022.105250
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Article ; Online: Reproductive and developmental evaluations of triclopyr acid, triclopyr butoxyethyl ester and triclopyr triethylamine salt in the rat.

Barlow, Susan M / Terry, Claire / Gehen, Sean / Corvaro, Marco

Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association

2022 Volume 161, Page(s) 112806

Abstract: Reproductive and developmental toxicity studies have been conducted in rat and rabbit on triclopyr acid and its active-ingredient variants, triclopyr butoxyethyl ester (T-BEE) and triclopyr triethylamine salt (T-TEA). In this paper the results of a rat ... ...

Abstract	Reproductive and developmental toxicity studies have been conducted in rat and rabbit on triclopyr acid and its active-ingredient variants, triclopyr butoxyethyl ester (T-BEE) and triclopyr triethylamine salt (T-TEA). In this paper the results of a rat two-generation study on triclopyr acid are presented, together with a review of all the reproductive and developmental toxicity data available from the rat studies. In the rat two-generation study, triclopyr acid was administered in the diet, giving doses of 0, 5, 25 or 250 mg/kg bw per day. Parental toxicity, especially maternal toxicity, occurred at 250 mg/kg bw per day with reduced body weight and feed intake, organ weight changes, and kidney toxicity. Slight kidney toxicity was also evident at 25 mg/kg bw per day. Developmental toxicity, in the form of reduced postnatal survival in the F1 and F2 generations and reductions in pre-weaning offspring body weight in both generations, was seen only at a dose causing significant parental toxicity. There were no effects on any other reproductive or developmental parameters at any dose. It is concluded that the developmental toxicity, seen only at the highest dose, was most likely attributable to maternal toxicity. The no-observed-adverse-effect levels were 5 mg/kg bw per day for parental toxicity and 25 mg/kg bw per day for developmental toxicity. From the multigeneration and developmental toxicity studies on triclopyr and its variants, it can also be concluded that triclopyr is not specifically toxic to reproduction and is not selectively toxic to the embryo, fetus or neonate in the rat.
MeSH term(s)	Animal Feed ; Animals ; Dose-Response Relationship, Drug ; Female ; Food Contamination ; Glycolates/administration & dosage ; Glycolates/toxicity ; Male ; Pregnancy ; Prenatal Exposure Delayed Effects ; Rats ; Rats, Sprague-Dawley ; Reproduction/drug effects
Chemical Substances	Glycolates ; triclopyr (MV06PHJ6I0)
Language	English
Publishing date	2022-01-05
Publishing country	England
Document type	Journal Article
ZDB-ID	782617-5
ISSN	1873-6351 ; 0278-6915
ISSN (online)	1873-6351
ISSN	0278-6915
DOI	10.1016/j.fct.2021.112806
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Article ; Online: Developmental toxicity studies on triclopyr acid, triclopyr butoxyethyl ester and triclopyr triethylamine salt in the rabbit.

Barlow, Susan M / Terry, Claire / Gehen, Sean / Corvaro, Marco

Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association

2022 Volume 161, Page(s) 112845

Abstract: Developmental toxicity studies have been conducted in the rabbit on triclopyr acid and its active-ingredient variants, triclopyr triethylamine salt (T-TEA) and triclopyr butoxyethyl ester (T-BEE), which are dissociated or hydrolysed in vivo to triclopyr ... ...

Abstract	Developmental toxicity studies have been conducted in the rabbit on triclopyr acid and its active-ingredient variants, triclopyr triethylamine salt (T-TEA) and triclopyr butoxyethyl ester (T-BEE), which are dissociated or hydrolysed in vivo to triclopyr acid. In this paper, the available developmental toxicity studies on triclopyr acid, T-TEA and T-BEE are summarised and evaluated. For triclopyr acid and T-TEA, there was no evidence of impaired reproductive performance, fetotoxicity, or teratogenicity, even at maternally toxic doses. The no-observed-adverse-effect levels (NOAELs) for developmental toxicity were 75 mg/kg bw per day for triclopyr acid and 100 mg/kg bw per day for T-TEA, equivalent to 72 mg/kg bw per day expressed as triclopyr acid. A study on T-BEE showed increased post-implantation loss and slight increases in skeletal anomalies and variants at the highest dose tested of 100 mg/kg bw per day, a maternally toxic dose. In a follow-up study on T-BEE, focusing on post-implantation loss, no general increase in post-implantation loss was observed, but one animal at 100 mg/kg bw per day with maternal toxicity had complete resorption of implants. The NOAEL for post-implantation loss was 60 mg/kg bw per day, equivalent to 44 mg/kg bw per day expressed as triclopyr acid. It cannot be excluded that T-BEE may be associated with increased post-implantation loss, but it was only seen in association with maternal toxicity. It is concluded that triclopyr acid and its variants are not specifically toxic to the rabbit embryo and fetus, since post-implantation loss only occurred at doses causing maternal toxicity.
MeSH term(s)	Abnormalities, Drug-Induced ; Animals ; Dose-Response Relationship, Drug ; Female ; Fetus/drug effects ; Glycolates/chemistry ; Glycolates/toxicity ; No-Observed-Adverse-Effect Level ; Rabbits ; Reproduction/drug effects
Chemical Substances	Glycolates ; triclopyr (MV06PHJ6I0)
Language	English
Publishing date	2022-02-02
Publishing country	England
Document type	Journal Article
ZDB-ID	782617-5
ISSN	1873-6351 ; 0278-6915
ISSN (online)	1873-6351
ISSN	0278-6915
DOI	10.1016/j.fct.2022.112845
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Article ; Online: The ADME profile of the fungicide tricyclazole in rodent via the oral route: A critical review for human health safety assessment.

Corvaro, Marco / Bartels, Michael

Regulatory toxicology and pharmacology : RTP

2019 Volume 108, Page(s) 104438

Abstract: Herein, we publish data from regulatory studies investigating the oral ADME (absorption, distribution, metabolism, excretion) of tricyclazole in vivo, in silico and in vitro. The oral route is relevant to human dietary exposure assessment. Tricyclazole ... ...

Abstract	Herein, we publish data from regulatory studies investigating the oral ADME (absorption, distribution, metabolism, excretion) of tricyclazole in vivo, in silico and in vitro. The oral route is relevant to human dietary exposure assessment. Tricyclazole is readily absorbed and highly bioavailable in rodents (>86%) with indication of saturation of absorption at high doses. Enterohepatic recirculation is evident. Excretion occurs quickly both via urinary (31-64%) and faecal routes (39-65%), with substantial biliary elimination in the rat (≥58%). The tricyclazole-derived radioactivity is distributed to major organs, including those investigated in in vivo genotoxicity studies (liver, kidney, gastrointestinal tract and bone marrow). There is no evidence of bioaccumulation. Metabolism is extensive (approximately 30 metabolites), with the liver being identified as the primary metabolism organ with Phase I and II enzymes involved. Several metabolites are formed following an initial cleavage of the central thiazole ring, with no loss of free triazole from the remaining phenyl ring. A group of 4 metabolites derive from an initial oxidation step with the formation of the tricyclazole-alcohol, a relevant crop metabolite, and account for up to 13% of the administered dose. In vitro metabolism, investigated with liver microsomes, confirmed that humans do not form unique metabolites.
MeSH term(s)	Administration, Oral ; Animals ; Fungicides, Industrial/pharmacokinetics ; Humans ; Risk Assessment ; Thiazoles/pharmacokinetics
Chemical Substances	Fungicides, Industrial ; Thiazoles ; tricyclazole (R7U3MEU7VR)
Language	English
Publishing date	2019-08-25
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2019.104438
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Article ; Online: GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations.

Corvaro, Marco / Henriquez, Joseph / Settivari, Raja / Mattson, Ulrika / Forreryd, Andy / Gradin, Robin / Johansson, Henrik / Gehen, Sean

Regulatory toxicology and pharmacology : RTP

2024 Volume 148, Page(s) 105595

Abstract: Several New Approach Methodologies (NAMs) for hazard assessment of skin sensitisers have been formally validated. However, data regarding their applicability on certain product classes are limited. The purpose of this project was to provide initial ... ...

Abstract	Several New Approach Methodologies (NAMs) for hazard assessment of skin sensitisers have been formally validated. However, data regarding their applicability on certain product classes are limited. The purpose of this project was to provide initial evidence on the applicability domain of GARD™skin and GARD™potency for the product class of agrochemical formulations. For this proof of concept, 30 liquid and 12 solid agrochemical formulations were tested in GARDskin for hazard predictions. Formulations predicted as sensitisers were further evaluated in the GARDpotency assay to determine GHS skin sensitisation category. The selected formulations were of product types, efficacy groups and sensitisation hazard classes representative of the industry's products. The performance of GARDskin was estimated by comparing results to existing in vivo animal data. The overall accuracy, sensitivity, and specificity were 76.2% (32/42), 85.0% (17/20), and 68.2% (15/22), respectively, with the predictivity for liquid formulations being slightly higher compared to the solid formulations. GARDpotency correctly subcategorized 14 out of the 17 correctly predicted sensitisers. Lack of concordance was justifiable by compositional or borderline response analysis. In conclusion, GARDskin and GARDpotency showed satisfactory performance in this initial proof-of-concept study, which supports consideration of agrochemical formulations being within the applicability domain of the test methods.
MeSH term(s)	Animals ; Agrochemicals/chemistry ; Irritants/pharmacology ; Skin ; Biological Assay ; Proof of Concept Study ; Animal Testing Alternatives ; Dermatitis, Allergic Contact
Chemical Substances	Agrochemicals ; Irritants
Language	English
Publishing date	2024-03-05
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2024.105595
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Article ; Online: Use of guinea pig data to obtain starting points for skin sensitisation risk assessment - A commentary.

Basketter, David / Corea, Namali / Corvaro, Marco / Grivel, Arthur / Kluxen, Felix M / Morgan, Neil / Wiemann, Christiane

Regulatory toxicology and pharmacology : RTP

2024 Volume 148, Page(s) 105584

Abstract: The increasing drive to understand the likelihood of skin sensitisation from plant protection products (PPPs) in workers and the general public has resulted in recent initiatives to establish a quantitative risk assessment (QRA) methodology applicable to ...

Abstract	The increasing drive to understand the likelihood of skin sensitisation from plant protection products (PPPs) in workers and the general public has resulted in recent initiatives to establish a quantitative risk assessment (QRA) methodology applicable to these products and their exposure scenarios. The effective evaluation of skin sensitising substances requires not only the identification of that toxicological hazard, but also determination of relative sensitising potency. Typically, this has been achieved by interpretation of local lymph node assay (LLNA) dose response data, delivering what is known as the EC3 value. This permitted regulatory division of skin sensitisers into defined potency sub-categories, but more importantly enabled derivation of a no expected sensitisation induction level (NESIL) as the point of departure for QRA. However, for many existing substances there is no LLNA data, only older guinea pig results exist. To avoid additional (in vivo) testing, an approach has been outlined to employ guinea pig data and existing regulatory guidelines on the determination of potency sub-categorisation to provide a guinea pig based NESIL. The approach adopts a conservative extrapolation from LLNA NESIL benchmarks to deliver points of departure as the basis for the type of QRA process already in successful use by other industries.
MeSH term(s)	Guinea Pigs ; Animals ; Dermatitis, Allergic Contact/prevention & control ; Allergens/toxicity ; Skin ; Local Lymph Node Assay ; Risk Assessment/methods
Chemical Substances	Allergens
Language	English
Publishing date	2024-02-28
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2024.105584
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Article: Reproductive and developmental evaluations of triclopyr acid, triclopyr butoxyethyl ester and triclopyr triethylamine salt in the rat

Barlow, Susan M. / Terry, Claire / Gehen, Sean / Corvaro, Marco

Food and chemical toxicology. 2022 Mar., v. 161

2022

Abstract	Reproductive and developmental toxicity studies have been conducted in rat and rabbit on triclopyr acid and its active-ingredient variants, triclopyr butoxyethyl ester (T-BEE) and triclopyr triethylamine salt (T-TEA). In this paper the results of a rat two-generation study on triclopyr acid are presented, together with a review of all the reproductive and developmental toxicity data available from the rat studies. In the rat two-generation study, triclopyr acid was administered in the diet, giving doses of 0, 5, 25 or 250 mg/kg bw per day. Parental toxicity, especially maternal toxicity, occurred at 250 mg/kg bw per day with reduced body weight and feed intake, organ weight changes, and kidney toxicity. Slight kidney toxicity was also evident at 25 mg/kg bw per day. Developmental toxicity, in the form of reduced postnatal survival in the F1 and F2 generations and reductions in pre-weaning offspring body weight in both generations, was seen only at a dose causing significant parental toxicity. There were no effects on any other reproductive or developmental parameters at any dose. It is concluded that the developmental toxicity, seen only at the highest dose, was most likely attributable to maternal toxicity. The no-observed-adverse-effect levels were 5 mg/kg bw per day for parental toxicity and 25 mg/kg bw per day for developmental toxicity. From the multigeneration and developmental toxicity studies on triclopyr and its variants, it can also be concluded that triclopyr is not specifically toxic to reproduction and is not selectively toxic to the embryo, fetus or neonate in the rat.
Keywords	developmental toxicity ; diet ; feed intake ; fetus ; neonates ; nephrotoxicity ; progeny ; rabbits ; rats ; reproduction ; tissue weight ; triclopyr
Language	English
Dates of publication	2022-03
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	782617-5
ISSN	1873-6351 ; 0278-6915
ISSN (online)	1873-6351
ISSN	0278-6915
DOI	10.1016/j.fct.2021.112806
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Article: Developmental toxicity studies on triclopyr acid, triclopyr butoxyethyl ester and triclopyr triethylamine salt in the rabbit

Barlow, Susan M. / Terry, Claire / Gehen, Sean / Corvaro, Marco

Food and chemical toxicology. 2022 Mar., v. 161

2022

Abstract	Developmental toxicity studies have been conducted in the rabbit on triclopyr acid and its active-ingredient variants, triclopyr triethylamine salt (T-TEA) and triclopyr butoxyethyl ester (T-BEE), which are dissociated or hydrolysed in vivo to triclopyr acid. In this paper, the available developmental toxicity studies on triclopyr acid, T-TEA and T-BEE are summarised and evaluated. For triclopyr acid and T-TEA, there was no evidence of impaired reproductive performance, fetotoxicity, or teratogenicity, even at maternally toxic doses. The no-observed-adverse-effect levels (NOAELs) for developmental toxicity were 75 mg/kg bw per day for triclopyr acid and 100 mg/kg bw per day for T-TEA, equivalent to 72 mg/kg bw per day expressed as triclopyr acid. A study on T-BEE showed increased post-implantation loss and slight increases in skeletal anomalies and variants at the highest dose tested of 100 mg/kg bw per day, a maternally toxic dose. In a follow-up study on T-BEE, focusing on post-implantation loss, no general increase in post-implantation loss was observed, but one animal at 100 mg/kg bw per day with maternal toxicity had complete resorption of implants. The NOAEL for post-implantation loss was 60 mg/kg bw per day, equivalent to 44 mg/kg bw per day expressed as triclopyr acid. It cannot be excluded that T-BEE may be associated with increased post-implantation loss, but it was only seen in association with maternal toxicity. It is concluded that triclopyr acid and its variants are not specifically toxic to the rabbit embryo and fetus, since post-implantation loss only occurred at doses causing maternal toxicity.
Keywords	fetotoxicity ; fetus ; rabbits ; reproductive performance ; resorption ; teratogenicity ; triclopyr
Language	English
Dates of publication	2022-03
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	782617-5
ISSN	1873-6351 ; 0278-6915
ISSN (online)	1873-6351
ISSN	0278-6915
DOI	10.1016/j.fct.2022.112845
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Article ; Online: Increased Cell Proliferation as a Key Event in Chemical Carcinogenesis: Application in an Integrated Approach for the Testing and Assessment of Non-Genotoxic Carcinogenesis.

Strupp, Christian / Corvaro, Marco / Cohen, Samuel M / Corton, J Christopher / Ogawa, Kumiko / Richert, Lysiane / Jacobs, Miriam N

International journal of molecular sciences

2023 Volume 24, Issue 17

Abstract: In contrast to genotoxic carcinogens, there are currently no internationally agreed upon regulatory tools for identifying non-genotoxic carcinogens of human relevance. The rodent cancer bioassay is only used in certain regulatory sectors and is ... ...

Abstract	In contrast to genotoxic carcinogens, there are currently no internationally agreed upon regulatory tools for identifying non-genotoxic carcinogens of human relevance. The rodent cancer bioassay is only used in certain regulatory sectors and is criticized for its limited predictive power for human cancer risk. Cancer is due to genetic errors occurring in single cells. The risk of cancer is higher when there is an increase in the number of errors per replication (genotoxic agents) or in the number of replications (cell proliferation-inducing agents). The default regulatory approach for genotoxic agents whereby no threshold is set is reasonably conservative. However, non-genotoxic carcinogens cannot be regulated in the same way since increased cell proliferation has a clear threshold. An integrated approach for the testing and assessment (IATA) of non-genotoxic carcinogens is under development at the OECD, considering learnings from the regulatory assessment of data-rich substances such as agrochemicals. The aim is to achieve an endorsed IATA that predicts human cancer better than the rodent cancer bioassay, using methodologies that equally or better protect human health and are superior from the view of animal welfare/efficiency. This paper describes the technical opportunities available to assess cell proliferation as the central gateway of an IATA for non-genotoxic carcinogenicity.
MeSH term(s)	Animals ; Humans ; Carcinogenesis ; Carcinogens/toxicity ; Agrochemicals ; Biological Assay ; Cell Proliferation
Chemical Substances	Carcinogens ; Agrochemicals
Language	English
Publishing date	2023-08-26
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms241713246
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Article ; Online: Assessing the risk of induction of skin sensitization to plant protection products: A quantitative approach.

Corea, Namali / Corvaro, Marco / Kluxen, Felix M / Grivel, Arthur / Morgan, Neil / Wiemann, Christiane / Basketter, David

Regulatory toxicology and pharmacology : RTP

2023 Volume 141, Page(s) 105408

Abstract: Exposure to skin sensitizers is common and regulated in many industry sectors. For cosmetics, a risk-based approach has been implemented, focused on preventing the induction of sensitization. First, a No Expected Sensitization Induction Level (NESIL) is ... ...

Abstract	Exposure to skin sensitizers is common and regulated in many industry sectors. For cosmetics, a risk-based approach has been implemented, focused on preventing the induction of sensitization. First, a No Expected Sensitization Induction Level (NESIL) is derived, then modified by Sensitization Assessment Factors (SAFs) to derive an Acceptable Exposure Level (AEL). The AEL is used in risk assessment, being compared with an estimated exposure dose, specific to the exposure scenario. Since in Europe there is increased concern regarding exposure towards potentially sensitizing pesticides via spray drift, we explore how existing practice can be modified to allow Quantitative Risk Assessment (QRA) of pesticides for bystanders and residents. NESIL derivation by the Local Lymph Node Assay (LLNA), the globally required in vivo assay for this endpoint, is reviewed alongside consideration of appropriate SAFs. Using a case study, the principle that the NESIL in μg/cm
MeSH term(s)	Humans ; Allergens/toxicity ; Dermatitis, Allergic Contact/etiology ; Dermatitis, Allergic Contact/prevention & control ; Local Lymph Node Assay ; Pesticides/toxicity ; Risk Assessment ; Skin ; Skin Tests
Chemical Substances	Allergens ; Pesticides
Language	English
Publishing date	2023-05-18
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2023.105408
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