Grouping of esters of 4-hydroxybenzoic acid for hazard assessment.
Journal
Archives of toxicology
ISSN: 1432-0738
Titre abrégé: Arch Toxicol
Pays: Germany
ID NLM: 0417615
Informations de publication
Date de publication:
05 Dec 2023
05 Dec 2023
Historique:
received:
11
09
2023
accepted:
16
11
2023
medline:
6
12
2023
pubmed:
6
12
2023
entrez:
5
12
2023
Statut:
aheadofprint
Résumé
Hazardous properties of a large number of esters of 4-hydroxybenzoic acid (parabens) have been proposed by ECHA to be assessed as a group. We recommend to restrict the grouping approach to short chain esters, i.e. methyl, ethyl, propyl and butyl paraben which are very similar in chemical structures, physicochemical properties, toxicokinetics, and hazardous properties. While these parabens show a weak estrogenicity in some in vitro or in vivo screening assays, they do not induce estrogen-receptor-mediated adverse effects in intact animals. Therefore, there is no support regarding classification and labeling of endocrine disruption or reproductive toxicity of these parabens.
Identifiants
pubmed: 38052763
doi: 10.1007/s00204-023-03641-x
pii: 10.1007/s00204-023-03641-x
doi:
Types de publication
Letter
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Abbas S, Greige-Gerges H, Karam N, Piet MH, Netter P, Magdalou J (2010) Metabolism of parabens (4-hydroxybenzoic acid esters) by hepatic esterases and UDP-glucuronosyltransferases in man. Drug Metab Pharmacokinet 25:568–577
doi: 10.2133/dmpk.DMPK-10-RG-013
pubmed: 20930423
Api AM, Belsito D, Bruze M, Cadby P, Calow P, Dagli ML, Dekant W, Ellis G, Fryer AD, Fukayama M, Griem P, Hickey C, Kromidas L, Lalko JF, Liebler DC, Miyachi Y, Politano VT, Renskers K, Ritacco G, Salvito D, Schultz TW, Sipes IG, Smith B, Vitale D, Wilcox DK (2015) Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients. Food Chem Toxicol 82:S1-s19
doi: 10.1016/j.fct.2014.11.014
pubmed: 25510979
Aubert N, Ameller T, Legrand J-J (2012) Systemic exposure to parabens: pharmacokinetics, tissue distribution, excretion balance and plasma metabolites of [14C]-methyl-, propyl- and butylparaben in rats after oral, topical or subcutaneous administration. Food Chem Toxicol 50:445–454
doi: 10.1016/j.fct.2011.12.045
pubmed: 22265941
Cirep CIR, Cherian P, Zhu J, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, Heldreth B (2020) Amended safety assessment of parabens as used in cosmetics. Int J Toxicol 39:5S-97S
CoRAP. Substance evaluation report EC 202–804–9: 4-hydroxybenzoic acid. 2016. Available online at: https://echa.europa.eu/documents/10162/d31417dd-484b-f6e9-3184-d5522d536453 .
CoRAP. Justification for removing a substance from CoRAP prior to evaluation, substance name ethyl 4-hydroxybenzoate (ethylparaben). 2022. Available online at: https://www.echa.europa.eu/documents/10162/578b6d23-9654-9d60-0841-e80240fdd5c8
Ding K, Kong X, Wang J, Lu L, Zhou W, Zhan T, Zhang C, Zhuang S (2017) Side chains of parabens modulate antiandrogenic activity. In vitro and molecular docking studies. Environ Sci Technol 51:6452–6460
doi: 10.1021/acs.est.7b00951
pubmed: 28466639
ECHA. European Chemicals Agency, Assessment of regulatory needs: Group Name: Paraben acid, salts and esters. 2022. Available online at: https://echa.europa.eu/documents/10162/7c9e3c51-a5e7-cba6-f651-9bde1f5ef362 .
ECHA. Report of the 8th Meeting of the Committee for Risk Assessment Working Group on Harmonised Classification and Labelling (RAC-64 CLH WG), 26 Jan 2023. 2023. Available online at: https://echa.europa.eu/documents/10162/17352003/rac_64_clh_wg_minutes_en.pdf/116382ab-3e72-7ac9-a831-169e89c8ddd2?t=1676284370096 .
ECHA, ECA, EFSA, EFSA, With the technical support of the JRC, Andersson N, Arena M, Auteri D, Barmaz S, Grignard E, Kienzler A, Lepper P, Lostia AM, Munn S, Parra Morte JM, Pellizzato F, Tarazona J, Terron A, Van der Linden S. Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA J. 2018; 16:e05311
ECHA-RAAF. European Chemicals Agency, Read-Across Assessment Framework (RAAF), ECHA-17-R-01-EN. 2017. Available online at: https://data.europa.eu/doi/ https://doi.org/10.2823/619212 .
Fayyaz S, Kreiling R, Sauer UG (2021) Application of grouping and read-across for the evaluation of parabens of different chain lengths with a particular focus on endocrine properties. Arch Toxicol 95:853–881
doi: 10.1007/s00204-020-02967-0
pubmed: 33459807
pmcid: 7904550
Golden R, Gandy J, Vollmer G (2005) A review of the endocrine activity of parabens and implications for potential risks to human health. Crit Rev Toxicol 35:435–458
doi: 10.1080/10408440490920104
pubmed: 16097138
HealthCanada. Draft screening assessment—Parabens group. 2020. Available online at: https://www.canada.ca/content/dam/eccc/documents/pdf/pded/parabens/Draft-screening-assessment-parabens-group.pdf .
Hoberman AM, Schreur DK, Leazer T, Daston GP, Carthew P, Re T, Loretz L, Mann P (2008) Lack of effect of butylparaben and methylparaben on the reproductive system in male rats. Birth Defects Res B 83:123–133
doi: 10.1002/bdrb.20153
Hubbard TD, Brix A, Blystone CR, McIntyre BS, Shockley K, Cunny H, Waidyanatha S, Turner KJ, McBride S, Roberts GK (2020) Butylparaben multigenerational reproductive assessment by continuous breeding in Hsd: Sprague Dawley SD rats following dietary exposure. Reprod Toxicol 96:258–272
doi: 10.1016/j.reprotox.2020.07.006
pubmed: 32702374
pmcid: 7837387
Jacobs MN, Laws SC, Willett K, Schmieder P, Odum J (2013) In vitro metabolism and bioavailability tests for endocrine active substances: what is needed next for regulatory purposes? ALTEX Altern Anim Exp 30:331–351
Lemini C, Jaimez R, Avila ME, Franco Y, Larrea F, Lemus AE (2003) In vivo and in vitro estrogen bioactivities of alkyl parabens. Toxicol Ind Health 19:69–79
doi: 10.1191/0748233703th177oa
pubmed: 15697177
Natsch A, Adamsson G, Rocha V (2023) ECHA ARN documents: chemical grouping without a toxicological rationale. Arch Toxicol 97:1433–1437
doi: 10.1007/s00204-023-03479-3
pubmed: 36947183
pmcid: 10110713
Obringer C, Wu S, Troutman J, Karb M, Lester C (2021) Effect of chain length and branching on the in vitro metabolism of a series of parabens in human liver S9, human skin S9, and human plasma. Regul Toxicol Pharmacol 122:104918
doi: 10.1016/j.yrtph.2021.104918
pubmed: 33741472
OECD. Conceptual Framework for Testing and Assessment of Endocrine Disrupters (as revised in 2012). 2012. Available online at: https://www.oecd.org/env/ehs/testing/OECD%20Conceptual%20Framework%20for%20Testing%20and%20Assessment%20of%20Endocrine%20Disrupters%20for%20the%20public%20website.pdf .
OECD. Guidance on Grouping of Chemicals, Second Edition, OECD Series on Testing and Assessment, No. 194, OECD Publishing, Paris. 2017. Available online at: https://doi.org/10.1787/9789264274679-en .
OECD. Series on testing and assessment. Revised Guidance Document No. 150 on standardised test guidelines for evaluating chemicals for endocrine disruption. 2018. OECD Publishing, Paris. Available online at: https://doi.org/10.1787/9789264304741-en .
Okubo T, Yokoyama Y, Kano K, Kano I (2001) ER-dependent estrogenic activity of parabens assessed by proliferation of human breast cancer MCF-7 cells and expression of ERα and PR. Food Chem Toxicol 39:1225–1232
doi: 10.1016/S0278-6915(01)00073-4
pubmed: 11696396
Patlewicz G, Roberts DW, Aptula A, Blackburn K, Hubesch B (2013) Workshop: use of “read-across” for chemical safety assessment under REACH. Regul Toxicol Pharmacol 65:226–228
doi: 10.1016/j.yrtph.2012.12.004
pubmed: 23266660
Routledge EJ, Parker J, Odum J, Ashby J, Sumpter JP (1998) Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicol Appl Pharmacol 153:12–19
doi: 10.1006/taap.1998.8544
pubmed: 9875295
SCCS. Scientific Committee on Consumer Safety—Opinion on parabens (SCCS/1348/10, COLIPA n° P82). 2011. 14 Dec 2010, revision of 22 Mar 2011.
SCCS. Scientific Committee on Consumer Safety—Opinion on parabens, updated request on propyl- and butylparaben (SCCS/1514/13, COLIPA n° P82). Adopted 3 May 2013.
SCCS (2021) Scientific Committee on Consumer Safety—Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7). Regul Toxicol Pharmacol 125:105005
doi: 10.1016/j.yrtph.2021.105005
Schultz TW, Amcoff P, Berggren E, Gautier F, Klaric M, Knight DJ, Mahony C, Schwarz M, White A, Cronin MTD (2015) A strategy for structuring and reporting a read-across prediction of toxicity. Regul Toxicol Pharmacol 72:586–601
doi: 10.1016/j.yrtph.2015.05.016
pubmed: 26003513
Scialli AR (2011) Reproductive effects of the parabens. Reprod Toxicol 32:138–140
doi: 10.1016/j.reprotox.2011.03.005
pubmed: 21440055
Soni MG, Carabin IG, Burdock GA (2005) Safety assessment of esters of p-hydroxybenzoic acid (parabens). Food Chem Toxicol 43:985–1015
doi: 10.1016/j.fct.2005.01.020
pubmed: 15833376
Terasaki M, Kamata R, Shiraishi F, Makino M (2009) Evaluation of estrogenic activity of parabens and their chlorinated derivatives by using the yeast two-hybrid assay and the enzyme-linked immunosorbent assay. Environ Toxicol Chem 28:204–208
doi: 10.1897/08-225.1
pubmed: 18717622
van Meeuwen JA, van Son O, Piersma AH, de Jong PC, van den Berg M (2008) Aromatase inhibiting and combined estrogenic effects of parabens and estrogenic effects of other additives in cosmetics. Toxicol Appl Pharmacol 230:372–382
doi: 10.1016/j.taap.2008.03.002
pubmed: 18486175
WHO/IPCS. International Programme on Chemical, Safety: Global assessment on the state of the science of endocrine disruptors. 2002. Available online at: https://apps.who.int/iris/bitstream/handle/10665/67357/WHO_PCS_EDC_02.2.pdf?sequence=1&isAllowed=y . World Health Organization, Geneva
Witorsch RJ, Thomas JA (2010) Personal care products and endocrine disruption: a critical review of the literature. Crit Rev Toxicol 40(Suppl 3):1–30
doi: 10.3109/10408444.2010.515563
pubmed: 20932229
Wohlleben W, Mehling A, Landsiedel R (2023) Lessons learned from the grouping of chemicals to assess risks to human health. Angew Chem Int Ed Engl 62:e202210651
doi: 10.1002/anie.202210651
pubmed: 36254879