Update of the risk assessment on 3-monochloropropane diol and its fatty acid esters

EFSA Journal

Volumn 16, Issue 1, 2018, Pages

  Knutsen, Helle Katrine ^a   Alexander, Jan ^a   Barregård, Lars ^a   Bignami, Margherita ^a   Brüschweiler, Beat ^a   Ceccatelli, Sandra ^a   Cottrill, Bruce ^a   Dinovi, Michael ^a   Edler, Lutz ^a   Grasl Kraupp, Bettina ^a   more..

^a Ron)

Author keywords

3 MCPD; benchmark dose; fatty acid esters; process contaminant; refined vegetable oils; risk assessment

Indexed keywords

EID: 85059785344     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2018.5083     Document Type: Review

References (58)

1. Ban Y, Asanabe U, Inagaki S, Sasaki M, Nakatsuka T and Matsumoto H, 1999. Effects of alpha-chlorohydrin on rat sperm motions in relation to male reproductive functions. Journal of Toxicological Sciences, 24, 407–413.
2. Ban Y, Naya M, Nishimura T, Kaneto M, Kishi K, Inoue T, Yoshizaki H and Ooshima Y, 2001. Collaborative study on rat sperm motion analysis using Cell Soft Series 4000 semen analyzer. Journal of Toxicological Sciences, 26, 9–24. https://doi.org/10.2131/jts.26.9
3. Banik UK, Tanikella T and Rakhit S, 1972. Oral antifertility effects of hallo propanediol derivatives in male rats. Journal of Reproduction and Fertility, 30, 117–124.
4. Barocelli E CA, Mutti A and Petronini PG, 2011. Comparison between 3-MCPD and its palmitic esters in a 90-day toxicological study. EFSA supporting publication 2011;8(9):EN-187, 131 pp. https://doi.org/10.2903/sp.efsa.2011.en-187
5. Braeuning A, Sawada S, Oberemm A and Lampen A, 2015. Analysis of 3-MCPD- and 3-MCPD dipalmitate-induced proteomic changes in rat liver. Food and Chemical Toxicology, 86, 374–384. https://doi.org/10.1016/j.fct.2015.11.010
6. Buhrke T, Voss L, Briese A, Stephanowitz H, Krause E, Braeuning A and Lampen A, 2017. Oxidative inactivation of the endogenous antioxidant protein DJ-1 by the food contaminants 3-MCPD and 2-MCPD. Archives of Toxicology, https://doi.org/10.1007/s00204-017-2027-5
7. Cho WS, Han BS, Lee H, Kim C, Nam KT, Park K, Choi M, Kim SJ, Kim SH, Jeong J and Jang DD, 2008a. Subchronic toxicity study of 3-monochloropropane-1,2-diol administered by drinking water to B6C3F1 mice. Food and Chemical Toxicology, 46, 1666–1673. https://doi.org/10.1016/j.fct.2007.12.030
8. Cho WS, Han BS, Nam KT, Park K, Choi M, Kim SH, Jeong J and Jang DD, 2008b. Carcinogenicity study of 3-monochloropropane-1,2-diol in Sprague-Dawley rats. Food and Chemical Toxicology, 46, 3172–3177. https://doi.org/10.1016/j.fct.2008.07.003
9. Coppola JA, 1969. An extragonadal male antifertility agent. Life Sciences, 8, 43–48. https://doi.org/10.1016/0024-3205(69)90291-4
10. Creasy D, Bube A, de Rijk E, Kandori H, Kuwahara M, Masson R, Nolte T, Reams R, Regan K, Rehm S, Rogerson P and Whitney K, 2012. Proliferative and nonproliferative lesions of the rat and mouse male reproductive system. Toxicologic Pathology, 40, 40s–121s. https://doi.org/10.1177/0192623312454337
11. EFSA (European Food Safety Authority), 2005. Opinion of the Scientific Committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic. EFSA Journal 2005;3(10):282, 33 pp. https://doi.org/10.2903/j.efsa.2005.282
12. EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on a request from EFSA on the use of the benchmark dose approach in risk assessment. EFSA Journal 2009;7(6):1150, 72 pp. https://doi.org/10.2903/j.efsa.2009.1150
13. EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2016. Scientific opinion on the risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. EFSA Journal 2016;14(5):4426, 159 pp. https://doi.org/10.2903/j.efsa.2016.4426
14. EFSA Scientific Committee, 2017. Update: guidance on the use of the benchmark dose approach in risk assessment. EFSA Journal 2017;15(1):4658, 41 pp. https://doi.org/10.2903/j.efsa.2017.4658
15. El Ramy R, Ould Elhkim M, Poul M, Forest MG, Leduque P and Le Magueresse-Battistoni B, 2006. Lack of effect on rat testicular organogenesis after in utero exposure to 3-monochloropropane-1,2-diol (3-MCPD). Reprod Toxicol 2006 Oct, 22, 485–492.
16. Ericsson RJ and Baker VF, 1970. Male antifertility compounds: biological properties of U-5897 and U-l5,646. Journal of Reproduction and Fertility, 21, 267–273.
17. Ericsson SA and Ericsson RJ, 1996. Effects of norepinephrine/testosterone propionate on formation of epididymal lesion rats administered α-chlorohydrin. Advances in Contraceptive Delivery Systems, 12, 215–221.
18. FAO/WHO (Joint FAO/WHO Expert Committee on Food Additives), 2016. Joint FAO/WHO Expert Committee on Food Additives. Eighty-third meeting Rome, 8–17 November 2016. Summary and Conclusions Issued 23 November 2016. Available online: http://www.fao.org/3/a-bq821e.pdf
19. FAO/WHO (Joint FAO/WHO Expert Committee on Food Additives), 2017. Evaluation of certain contaminants in food. Technical Report Series 1002. Available online: http://apps.who.int/iris/bitstream/10665/254893/1/9789241210027-eng.pdf
20. Ford WC and Harrison A, 1983. The activity of glyceraldehyde 3-phosphate dehydrogenase in spermatozoa from different regions of the epididymis in laboratory rodents treated with alpha-chlorohydrin or 6-chloro-deoxyglucose. Journal of Reproduction and Fertility, 69, 147–156.
21. Ford WCL and Waites GMH, 1982. Activities of various 6-chloro-6-deoxysugars and (S)α-chlorohydrin in producing spermatocoeles in rats and paralysis in mice and in inhibiting glucose metabolism in bull spermatozoa in vitro. Journal of Reproduction and Fertility, 65, 177–183.
22. Helal TY, 1982. Chemo sterilant and rodenticidal effects of 3 chloro 1 2 propanediol epibloc against the albino laboratory rat and the Nile field rat. International Pest Control, 24, 20–23.
23. Hoyt JA, Fisher LF, Hoffman WP, Swisher DK and Seyler DE, 1994. Utilization of a short-term male reproductive toxicity study design to examine effects of alpha-chlorohydrin (3-chloro-1,2-propanediol). Reproductive Toxicology, 8, 237–250. Available online: https://doi.org/10.1016/0890-6238(94)90008-6
24. Jackson H, Rooney FR, Fitzpatrick RW and Gibson KH, 1977. Characterization and antifertility activity in rats of S(+) α chlorohydrin. Chemico-Biological Interactions, 17, 117–120. Available online: https://doi.org/10.1016/0009-2797(77)90077-1
25. Jelks K, Berger T, Horner C and Miller MG, 2001. α-chlorohydrin induced changes in sperm fertilizing ability in the rat: association with diminished sperm ATP levels and motility. Reproductive Toxicology, 15, 11–20. Available online: https://doi.org/10.1016/S0890-6238(00)00115-5
26. Johnson LA and Pursel VG, 1972. Reversible infertility in male swine fed alpha chlorohydrin. Journal of Animal Science, 34, 241–245.
27. Jones AR, 1983. Antifertility actions of alpha-chlorohydrin in the male. Australian Journal of Biological Sciences, 36, 333–350.
28. Jones AR and Porter LM, 1995. Inhibition of glycolysis in boar spermatozoa by alpha-chlorohydrin phosphate appears to be mediated by phosphatase activity. Reproduction Fertility and Development, 7, 1089–1094. https://doi.org/10.1071/rd9951089
29. Jones AR, Gadiel P and Stevenson D, 1981. The fate of oxalic acid in the Wistar rat. Xenobiotica, 11, 385–390.
30. Kaneto M, Kanamori S, Hishikawa A and Kishi K, 1999. Epididymal sperm motion as a parameter of male reproductive toxicity: sperm motion, fertility, and histopathology in ethinylestradiol-treated rats. Reproductive Toxicology, 13, 279–289.
31. Kaur S and Guraya SS, 1981. Biochemical observations on the protein and nucleic acid metabolism of the rat testis and epididymis after treatment with low doses of alpha-chlorohydrin. International Journal of Fertility, 26, 8–13.
32. Kawaguchi T, Kawachi M, Morikawa M, Kazuta H, Shibata K, Ishida M, Kitagawa N, Matsuo A and Kadota T, 2004. Key parameters of sperm motion in relation to male fertility in rats given α-chlorohydrin or nitrobenzene. Journal of Toxicological Sciences, 29, 217–231. Available online: https://doi.org/10.2131/jts.29.217
33. Kim SH, Lee IC, Lim JH, Moon C, Bae CS, Kim SH, Shin DH, Kim HC and Kim JC, 2012. Spermatotoxic effects of alpha-chlorohydrin in rats. Laboratory Animal Research, 28, 11–16. Available online: https://doi.org/10.5625/lar.2012.28.1.11
34. Kwack SJ, Kim SS, Choi YW, Rhee GS, Da Lee R, Seok JH, Chae SY, Won YH, Lim KJ, Choi KS, Park KL and Lee BM, 2004. Mechanism of antifertility in male rats treated with 3-monochloro-1,2-propanediol (3-MCPD). Journal of Toxicology and Environmental Health-Part A-Current Issues, 67, 2001–2011. Available online: https://doi.org/10.1080/15287390490514651
35. Larsen L, Scheike T, Jensen TK, Bonde JP, Ernst E, Hjollund NH, Zhou Y, Skakkebaek NE and Giwercman A, 2000. Computer-assisted semen analysis parameters as predictors for fertility of men from the general population. The Danish First Pregnancy Planner Study Team. Human Reproduction, 15, 1562–1567.
36. Li N, Liu Z, Jia X, Cui W, Wang W, Zhang X, Han C, Chen J and Wang M, 2003. Study on the toxicological effect of chloropropanols on rats. Wei sheng yan jiu = Journal of Hygiene Research, 32, 349–352.
37. Li Y, Liu S, Wang C, Li K, Shan YJ, Wang XJ and Sun CH, 2010. Novel biomarkers of 3-chloro-1,2-propanediol exposure by ultra performance liquid chromatography/mass spectrometry based metabonomic analysis of rat urine. Chemical Research in Toxicology, 23, 1012–1017. Available online: https://doi.org/10.1021/tx900400p
38. Lynch BS, Bryant DW, Hook GJ, Nestmann ER and Munro IC, 1998. Carcinogenicity of monochloro-1,2-propanediol (alpha-chlorohydrin, 3-MCPD). International Journal of Toxicology, 17, 47–76.
39. Mangelsdorf I, Buschmann J and Orthen B, 2003. Some aspects relating to the evaluation of the effects of chemicals on male fertility. Regulatory Toxicology and Pharmacology, 37, 356–369. Available online: https://doi.org/10.1016/S0273-2300(03)00026-6
40. Mineshima H, Fujioka M, Furukawa M, Ikeda T, Kinoshita K, Koida M, Kondoh K, Ozawa S, Oi A, Ohyama N, Takahashi H and Tanaka R, 2000. Comparison of sperm motility test methods (except computer-assisted sperm analysis) in rats under the condition of alfa-chlorohydrin treatment - collaborative investigation. Journal of Toxicological Sciences, 25, 443–454.
41. Onami S, Cho YM, Toyoda T, Mizuta Y, Yoshida M, Nishikawa A and Ogawa K, 2014. A 13-week repeated dose study of three 3-monochloropropane-1,2-diol fatty acid esters in F344 rats. Archives of Toxicology, 88, 871–880. Available online: https://doi.org/10.1007/s00204-013-1190-6
42. Perobelli JE, Alves TR, de Toledo FC, Fernandez CD, Anselmo-Franci JA, Klinefelter GR and Kempinas Wde G, 2012. Impairment on sperm quality and fertility of adult rats after antiandrogen exposure during prepuberty. Reproductive Toxicology, 33, 308–315. Available online: https://doi.org/10.1016/j.reprotox.2011.12.011
43. Rietjens IMCM, Scholz G, Berg I, Schilter B and Slob W, 2012. Refined hazard characterization of 3-MCPD using benchmark dose modeling. European Journal of Lipid Science and Technology, 114, 1140–1147. Available online: https://doi.org/10.1002/ejlt.201100145
44. Rooney FR and Jackson H, 1980. Antifertility and toxicological studies with aromatic esters of alpha-chlorohydrin in male rats. Chemico-Biological Interactions, 32, 233–241.
45. Sawada S, Oberemm A, Buhrke T, Meckert C, Rozycki C, Braeuning A and Lampen A, 2015. Proteomic analysis of 3-MCPD and 3-MCPD dipalmitate toxicity in rat testis. Food and Chemical Toxicology, 83, 84–92. Available online: https://doi.org/10.1016/j.fct.2015.06.002
46. Sawada S, Oberemm A, Buhrke T, Merschenz J, Braeuning A and Lampen A, 2016. Proteomic analysis of 3-MCPD and 3-MCPD dipalmitate-induced toxicity in rat kidney. Archives of Toxicology, 90, 1437–1448. Available online: https://doi.org/10.1007/s00204-015-1576-8
47. Sun J, Bai S, Bai W, Zou F, Zhang L, Su Z, Zhang Q, Ou S and Huang Y, 2013. Toxic mechanisms of 3-monochloropropane-1,2-diol on progesterone production in R2C rat Leydig cells. Journal of Agricultural and Food Chemistry, 61, 9955–9960. Available online: https://doi.org/10.1021/jf400809r
48. Sunahara G, Perrin I and Marchesini M, 1993. Carcinogenicity study on 3-monochloro-1,2-propane diol (3-MCPD) administered in drinking water to Fischer 344 rats. Unpublished report No. RE-SR93003. Nestec Ltd. Research & Development, Switzerland.
49. Takayama S, Akaike M, Kawashima K, Takahashi M and Kurokawa Y, 1995. A collaborative study in Japan on optimal treatment period and parameters for detection of male fertility disorders induced by drugs in rats. Journal of the American College of Toxicology, 14, 266–292.
50. US EPA (US Environmental Protection Agency), 2012. Benchmark Dose Technical Guidance. EPA/100/R-12/001. Available online: https://www.epa.gov/sites/production/files/2015-01/documents/benchmark_dose_guidance.pdf
51. Vickery BH, Erickson GI and Bennett JP, 1974. Mechanism of antifertility action of low doses of alpha-chlorohydrin in the male rat. Journal of Reproduction and Fertility, 38, 1–10.
52. Wheeler MW and Bailer AJ, 2008. Model averaging software for dichotomous dose response risk estimation. Journal of Statistical Software, 26, 1–15. Available online: https://doi.org/10.18637/jss.v026.i05
53. WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2012. Benchmark Dose Technical Guidance. EPA/100/R-12/001. Available online: https://www.epa.gov/sites/production/files/2015-01/documents/benchmark_dose_guidance.pdf
54. Yamada T, Inoue T, Sato A, Yamagishi K and Sato M, 1995. Effects of short-term administration of alpha-chlorohydrin on reproductive toxicity parameters in male Sprague-Dawley rats. Journal of Toxicological Sciences, 20, 195–205.
55. Youn JS, Cha SH, Park CW, Yang KM, Kim JY, Koong MK, Kang IS, Song IO and Han SC, 2011. Predictive value of sperm motility characteristics assessed by computer-assisted sperm analysis in intrauterine insemination with superovulation in couples with unexplained infertility. Clinical Experimental Reproduction Medicine, 38, 47–52. Available online: https://doi.org/10.5653/cerm.2011.38.1.47
56. Zenick H and Clegg ED, 1986. Issues in risk assessment in male reproductive toxicology. Journal of the American College of Toxicology, 5, 249–259. Available online: https://doi.org/10.3109/10915818609140749
57. Zhang H, Qian G, Ling X and Zhao J, 2008. Effects of S-alpha-chiorohydrin on male ICR mice fertility. Journal of Hygiene Research, 37, 133–136.
58. Zhang H, Zheng W, Wang X, Liu L and Qu W, 2012. Inhibitory effect of (S)-chlorohydrin on rat sperm motility and hyperactivation. Wei sheng yan jiu = Journal of Hygiene Research, 41, 704–709.