{"id":9033,"date":"2025-09-08T09:05:47","date_gmt":"2025-09-08T09:05:47","guid":{"rendered":"https:\/\/chromeclair.com\/?p=9033"},"modified":"2025-09-08T09:06:55","modified_gmt":"2025-09-08T09:06:55","slug":"2025-pigments-toxicology","status":"publish","type":"post","link":"https:\/\/chromeclair.com\/es\/2025-pigments-toxicology\/","title":{"rendered":"2025 Pigmentos y toxicolog\u00eda"},"content":{"rendered":"<p><strong>01 Panorama de la legislaci\u00f3n relativa a los pigmentos<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Para cumplir los requisitos medioambientales y de seguridad de los productos, los pl\u00e1sticos y los productos pl\u00e1sticos deben ajustarse a las normativas de los distintos pa\u00edses y regiones, sobre todo en lo que respecta a los controles de sustancias qu\u00edmicas. Entre ellas, las especificaciones qu\u00edmicas de los colorantes (pigmentos) son objeto de gran atenci\u00f3n. Dependiendo de la regi\u00f3n y del tipo de producto, los requisitos pertinentes pueden referirse a los propios pigmentos, a los materiales pl\u00e1sticos o abarcar disposiciones generales.<\/p>\n\n\n\n<p>Los efectos de las sustancias qu\u00edmicas sobre las mucosas, como la piel y los ojos, se eval\u00faan mediante ensayos de contacto con animales en laboratorios y se clasifican en funci\u00f3n de la gravedad de la irritaci\u00f3n o la corrosi\u00f3n. Las investigaciones indican que la gran mayor\u00eda de los pigmentos org\u00e1nicos no irritan la piel ni las mucosas; entre 192 pigmentos org\u00e1nicos de uso com\u00fan, s\u00f3lo 6 mostraron una irritaci\u00f3n leve en animales de experimentaci\u00f3n.<\/p>\n\n\n\n<p>Los pigmentos org\u00e1nicos no muestran toxicidad en las pruebas de exposici\u00f3n repetida y est\u00e1n excluidos de las sustancias que requieren la etiqueta R48 (la exposici\u00f3n repetida causa da\u00f1os graves) seg\u00fan la normativa de la UE.<\/p>\n\n\n\n<p>Los pigmentos inorg\u00e1nicos suelen contener metales pesados (definidos como los que tienen una densidad &gt;4,5 g\/mL). Excepto el polvo de aluminio, el negro de humo y el azul ultramarino\/violeta, la mayor\u00eda contienen metales pesados. Las pruebas realizadas indican que, aparte de los pigmentos a base de cromo y cadmio, la mayor\u00eda de los pigmentos inorg\u00e1nicos son inocuos desde el punto de vista toxicol\u00f3gico y ecol\u00f3gico.<\/p>\n\n\n\n<p><strong>02 Toxicolog\u00eda y ecolog\u00eda de los pigmentos<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Los pigmentos son poco solubles en agua y disolventes comunes. Su impacto ecol\u00f3gico procede principalmente de las emisiones de gases de escape y aguas residuales durante su producci\u00f3n.<\/p>\n\n\n\n<p><strong>-Gas residual:<\/strong>&nbsp;La contaminaci\u00f3n por polvo de pigmentos org\u00e1nicos requiere concentraciones en el aire inferiores a 6 mg\/m\u00b3 y debe someterse a depuraci\u00f3n antes de su vertido. El personal de producci\u00f3n debe llevar equipo de protecci\u00f3n.<\/p>\n\n\n\n<p><strong>- Aguas residuales: <\/strong>Los efluentes de producci\u00f3n pueden contener agentes cancer\u00edgenos como aminas arom\u00e1ticas y nitritos, por lo que es necesario un tratamiento f\u00edsico y biol\u00f3gico para que no sean t\u00f3xicos para los peces.<\/p>\n\n\n\n<p>Amplias investigaciones confirman que la toxicolog\u00eda y la ecolog\u00eda de los tintes abarcan nueve aspectos:<\/p>\n\n\n\n<p><strong>2.1 Toxicidad aguda<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Se refiere a la toxicidad resultante de una \u00fanica exposici\u00f3n. Las pruebas realizadas en ratones con 108 pigmentos org\u00e1nicos mostraron que su DL<sub>50<\/sub>&nbsp;superaban todos los 5000 mg\/kg, m\u00e1s que la sal de mesa (aproximadamente 3000 mg\/kg). La UE define las sustancias con una DL<sub>50<\/sub>&nbsp;por debajo de 2000 mg\/kg como t\u00f3xicos. Las pruebas de ETAD de m\u00e1s de 4.400 tintes y pigmentos revelaron que s\u00f3lo unos 8% presentan toxicidad aguda, principalmente tintes cati\u00f3nicos, tintes de complejos met\u00e1licos y productos que contienen auxiliares. En la actualidad, est\u00e1n prohibidos 13 pigmentos de toxicidad aguda (Tabla 1), entre los que se incluyen 6 pigmentos b\u00e1sicos, 2 pigmentos \u00e1cidos, 1 pigmento directo, 3 bases de tinte helado y 1 ftalocianina.<\/p>\n\n\n\n<p><strong>Tabla 1: Pigmentos de toxicidad aguda actualmente prohibidos en el mercado <\/strong><strong><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>N\u00famero de serie<\/strong><strong><\/strong><\/td><td><strong>Pigmento<\/strong><strong><\/strong><\/td><td><strong>N\u00famero de serie<\/strong><strong><\/strong><\/td><td><strong>Pigmento<\/strong><strong><\/strong><\/td><\/tr><tr><td>1<\/td><td>Basic Amarillo 21<\/td><td>8<\/td><td>Naranja \u00e1cida 165<\/td><\/tr><tr><td>2<\/td><td>Rojo b\u00e1sico 12<\/td><td>9<\/td><td>Naranja directo 62<\/td><\/tr><tr><td>3<\/td><td>Violeta b\u00e1sico 16<\/td><td>10<\/td><td>Tinte Ice Base 20<\/td><\/tr><tr><td>4<\/td><td>Azul b\u00e1sico 3<\/td><td>11<\/td><td>Tinte hielo Base 24<\/td><\/tr><tr><td>5<\/td><td>Azul b\u00e1sico 7<\/td><td>12<\/td><td>Tinte hielo Base 41<\/td><\/tr><tr><td>6<\/td><td>Azul b\u00e1sico 81<\/td><td>13<\/td><td>Ingrain Azul 2:2<\/td><\/tr><tr><td>7<\/td><td>Naranja \u00e1cida 156<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Estos pigmentos de toxicidad aguda presentan las siguientes caracter\u00edsticas: los pigmentos hidrosolubles constituyen la gran mayor\u00eda; se disuelven f\u00e1cilmente en disolventes polares como el etanol; y sus estructuras moleculares contienen fuertes sustituyentes donadores de electrones, como grupos amino o grupos amino sustituidos.<\/p>\n\n\n\n<p><strong>2.2 Toxicidad por exposici\u00f3n repetida<\/strong><strong><\/strong><\/p>\n\n\n\n<p>En ensayos de exposici\u00f3n repetida con dosis subletales en animales, la mayor\u00eda de los tintes y pigmentos no mostraron toxicidad org\u00e1nica a dosis no superiores a 1.000 mg\/kg.<\/p>\n\n\n\n<p><strong>2.3 Irritaci\u00f3n<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Se refiere a los efectos irritantes sobre la piel y las mucosas. Las pruebas ETAD de 68 tintes y pigmentos encontraron que aproximadamente 30% causan irritaci\u00f3n ocular o cut\u00e1nea, en parte atribuible a los aditivos.<\/p>\n\n\n\n<p><strong>2.4 Alergenicidad<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Algunos pigmentos pueden provocar alergias cut\u00e1neas o respiratorias. Los pigmentos alerg\u00e9nicos en los textiles deben controlarse por debajo de 0,006%. El ETAD identific\u00f3 27 pigmentos alerg\u00e9nicos (cuadro 2), de los cuales 26 son colorantes dispersos y 1 es un colorante \u00e1cido; la norma Oeko-Tex Standard 100 enumera 20. Sus caracter\u00edsticas comunes son: estructuras predominantemente azoicas o antraquin\u00f3nicas, colorantes \u00e1cidos y colorantes dispersos. Sus caracter\u00edsticas comunes son: estructuras predominantemente azoicas o antraquin\u00f3nicas, peso molecular relativamente bajo (230 - 400), presencia de grupos fuertemente donadores de electrones, como hidroxilo o amino, y solubilidad en disolventes org\u00e1nicos.<\/p>\n\n\n\n<p><strong>Cuadro 2 Pigmentos alerg\u00e9nicos conocidos en la actualidad <\/strong><strong><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>N\u00famero de serie<\/strong><strong><\/strong><\/td><td><strong>Pigmento<\/strong><strong><\/strong><\/td><td><strong>N\u00famero de serie<\/strong><strong><\/strong><\/td><td><strong>Pigmento<\/strong><strong><\/strong><\/td><\/tr><tr><td>1<\/td><td>C.I. Disperse Yellow 1<\/td><td>15<\/td><td>C.I. Dispersi\u00f3n Azul 1<\/td><\/tr><tr><td>2<\/td><td>C.I. Disperse Yellow 3<\/td><td>16<\/td><td>C.I. Dispersi\u00f3n Azul 3<\/td><\/tr><tr><td>3<\/td><td>C.I. Disperse Yellow 9<\/td><td>17<\/td><td>C.I. Dispersi\u00f3n Azul 7<\/td><\/tr><tr><td>4<\/td><td>C.I. Disperse Amarillo 39<\/td><td>18<\/td><td>C.I. Dispersi\u00f3n Azul 26<\/td><\/tr><tr><td>5<\/td><td>C.I. Disperse Amarillo 49<\/td><td>19<\/td><td>C.I. Dispersi\u00f3n Azul 35<\/td><\/tr><tr><td>6<\/td><td>C.I. Dispersi\u00f3n Naranja 1<\/td><td>20<\/td><td>C.I. Azul disperso 85<\/td><\/tr><tr><td>7<\/td><td>C.I. Dispersi\u00f3n Naranja 3<\/td><td>21<\/td><td>C.I. Dispersi\u00f3n Azul 102<\/td><\/tr><tr><td>8<\/td><td>C.I. Dispersi\u00f3n Naranja 13<\/td><td>22<\/td><td>C.I. Dispersi\u00f3n Azul 106<\/td><\/tr><tr><td>9<\/td><td>C.I. Naranja Dispersa 37<\/td><td>23<\/td><td>C.I. Dispersi\u00f3n Azul 124<\/td><\/tr><tr><td>10<\/td><td>C.I. Naranja Dispersa 76<\/td><td>24<\/td><td>C.I. Dispersi\u00f3n Marr\u00f3n 1<\/td><\/tr><tr><td>11<\/td><td>C.I. Disperse Red 1<\/td><td>25<\/td><td>C.I. Dispersi\u00f3n Negro 1<\/td><\/tr><tr><td>12<\/td><td>C.I. Dispersi\u00f3n Rojo 11<\/td><td>26<\/td><td>C.I. Disperse Black 2<\/td><\/tr><tr><td>13<\/td><td>C.I. Disperse Red 15<\/td><td>27<\/td><td>C.I. \u00c1cido Negro 48<\/td><\/tr><tr><td>14<\/td><td>C.I. Disperse Red 17<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>2.5 Mutagenicidad<\/strong><strong><\/strong><\/p>\n\n\n\n<p>La genotoxicidad se eval\u00faa mediante pruebas como el ensayo de Ames. M\u00e1s de dos tercios de m\u00e1s de 200 tintes no muestran mutagenicidad, mientras que s\u00f3lo uno de 36 pigmentos org\u00e1nicos demuestra genotoxicidad. Las impurezas tambi\u00e9n pueden contribuir a los efectos mutag\u00e9nicos.<\/p>\n\n\n\n<p>La Tabla 3 enumera la mutagenicidad de 25 pigmentos org\u00e1nicos ensayados mediante el m\u00e9todo Ames, revelando s\u00f3lo efectos mutag\u00e9nicos menores en unas pocas variedades espec\u00edficas de pigmentos org\u00e1nicos.<\/p>\n\n\n\n<p><strong>Tabla 3: Resultados de las pruebas de mutagenicidad de los pigmentos org\u00e1nicos mediante el ensayo de Ames <\/strong><strong><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Pigmentos &nbsp;&nbsp;&nbsp;<\/strong><strong><\/strong><\/td><td><strong>\u00cdndice de tinte N\u00famero de estructura<\/strong><strong><\/strong><\/td><td><strong>Resultados<\/strong><strong><\/strong><\/td><td><strong>Pigmentos &nbsp;&nbsp;&nbsp;<\/strong><strong><\/strong><\/td><td><strong>\u00cdndice de tinte N\u00famero de estructura<\/strong><strong><\/strong><\/td><td><strong>Resultados<\/strong><strong><\/strong><\/td><\/tr><tr><td>C.I.Pigment Yellow 1<\/td><td>11680<\/td><td>Negativo<\/td><td>C.I. Pigmento Rojo 49:2<\/td><td>15630:2<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Amarillo 12<\/td><td>21090<\/td><td>Negativo<\/td><td>C.I. Pigmento Rojo 53:1<\/td><td>15585 1<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Amarillo 74<\/td><td>11741<\/td><td>Negativo<\/td><td>C.I. Pigmento Rojo 57:1<\/td><td>15850 1<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Naranja 5<\/td><td>12075<\/td><td>Positivo d\u00e9bil<\/td><td>C.I. Pigmento Rojo 63:1<\/td><td>158801<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Naranja 13<\/td><td>21110<\/td><td>Negativo<\/td><td>C.1. Pigmento Azul 15<\/td><td>74160<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Red 1<\/td><td>12070<\/td><td>Positivo d\u00e9bil<\/td><td>C1. Pigmento azul 15:1<\/td><td>74160.1<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Red 4<\/td><td>12085<\/td><td>Negativo<\/td><td>C1. Pigmento Azul 1512<\/td><td>74160 2<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigmento Rojo 22<\/td><td>12815<\/td><td>Negativo<\/td><td>C1. Pigmento Azul 15:3<\/td><td>74160-3<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigmento Rojo 23<\/td><td>12355<\/td><td>Negativo<\/td><td>C1. Pigmento Azul 15:4<\/td><td>74160 4<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Red 48:1<\/td><td>15865-1<\/td><td>Negativo<\/td><td>C.1. Pigmento Verde 7<\/td><td>74260<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Red 48:2<\/td><td>15865 2<\/td><td>Negativo<\/td><td>C.1. Pigmento Verde 36<\/td><td>74265<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigmento Rojo 49<\/td><td>15630<\/td><td>Negativo<\/td><td>C.1. Pigmento Violeta 19<\/td><td>73900<\/td><td>Negativo<\/td><\/tr><tr><td>C.I.Pigment Red 49:1<\/td><td>15630:1<\/td><td>Negativo<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>2.6 Toxicidad cr\u00f3nica y carcinogenicidad<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Algunos tintes pueden descomponerse y liberar aminas arom\u00e1ticas carcin\u00f3genas o presentar carcinogenicidad directa. El ETAD identific\u00f3 143 tintes potencialmente descomponibles en aminas carcin\u00f3genas, de los cuales 11 se clasificaron como carcin\u00f3genos directos, la mayor\u00eda con estructuras azoicas o sustituyentes amino. Pigmentos como la ftalocianina de cobre pueden adsorberse a las prote\u00ednas s\u00e9ricas y acumularse, afectando a la composici\u00f3n de la sangre.<\/p>\n\n\n\n<p><strong>2.7 Toxicidad acu\u00e1tica y biodegradabilidad<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Las pruebas de ETAD indican que 59% de tintes y pigmentos muestran una baja toxicidad en peces (LD50 &gt; 100 mg\/L), mientras que s\u00f3lo 2% demuestran una alta toxicidad (LD50 &lt; 1 mg\/L). En las pruebas de toxicidad bacteriana, un peque\u00f1o n\u00famero de tintes inhiben el crecimiento bacteriano.<\/p>\n\n\n\n<p><strong>2.8 Irritaci\u00f3n de la piel y las mucosas<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Entre los 192 pigmentos org\u00e1nicos, s\u00f3lo un n\u00famero muy reducido presenta irritaci\u00f3n en la piel y las mucosas de animales de experimentaci\u00f3n, incluidos los efectos de los aditivos.<\/p>\n\n\n\n<p><strong>2.9 Impurezas en los pigmentos<\/strong><\/p>\n\n\n\n<p><strong>- Trazas de aminas arom\u00e1ticas:<\/strong>&nbsp;Los pa\u00edses imponen l\u00edmites a su contenido; por ejemplo, los materiales de envasado de alimentos exigen niveles inferiores a 50\u03bcg\/g.<\/p>\n\n\n\n<p><strong>- Trazas de metales pesados:<\/strong>&nbsp;La investigaci\u00f3n de la DCMA estadounidense indica que los niveles de metales pesados de los pigmentos org\u00e1nicos cumplen la normativa.<\/p>\n\n\n\n<p><strong>- Bifenilos policlorados (PCB): <\/strong>Estrictamente restringido en Europa y EE.UU., puede estar presente en ciertos pigmentos azoicos o pigmentos producidos utilizando disolventes clorados.<\/p>\n\n\n\n<p>En resumen, los pigmentos org\u00e1nicos no presentan toxicidad aguda, toxicidad por dosis repetidas, mutagenicidad significativa ni carcinogenicidad en condiciones convencionales. La prohibici\u00f3n alemana de 1994 s\u00f3lo se aplica a los tintes, no a los pigmentos org\u00e1nicos. Sin embargo, hay que seguir prestando atenci\u00f3n a las aminas arom\u00e1ticas nocivas en los auxiliares de producci\u00f3n, aditivos y materias primas. Adem\u00e1s, hay que vigilar las variedades propensas a descomponer sustancias nocivas a altas temperaturas (por ejemplo, los pigmentos a base de biclorobenzidina) y los subproductos como las dioxinas que pueden formarse durante el tratamiento de las aguas residuales.<\/p>","protected":false},"excerpt":{"rendered":"<p>01 Overview of Pigment-Related Legislation To meet product safety and environmental requirements, plastics and plastic products must comply with regulations across countries and regions, particularly concerning chemical substance controls. Among these, chemical specifications for colorants (pigments) receive significant attention. Depending on the region and product type, relevant requirements may target the pigments themselves, the plastic [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9033","post","type-post","status-publish","format-standard","hentry","category-gel-polish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pigments &amp; Toxicology<\/title>\n<meta name=\"description\" content=\"To meet product safety and environmental requirements, plastics and plastic products must comply with regulations across countries and regions, particularly concerning chemical substance controls. Among these, chemical specifications for colorants (pigments) receive significant attention. 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