{"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":"

01 Panorama de la legislaci\u00f3n relativa a los pigmentos<\/strong><\/strong><\/p>\n\n\n\n

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

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

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

Inorganic pigments often contain heavy metals (defined as having a density >4.5 g\/mL). Except for aluminum powder, carbon black, and ultramarine blue\/violet, most contain heavy metals. Testing indicates that, apart from chromium and cadmium-based pigments, most inorganic pigments are harmless in terms of toxicology and ecology.<\/p>\n\n\n\n

02 Toxicolog\u00eda y ecolog\u00eda de los pigmentos<\/strong><\/strong><\/p>\n\n\n\n

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

-Gas residual:<\/strong>\u00a0La 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

- 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

Amplias investigaciones confirman que la toxicolog\u00eda y la ecolog\u00eda de los tintes abarcan nueve aspectos:<\/p>\n\n\n\n

2.1 Toxicidad aguda<\/strong><\/strong><\/p>\n\n\n\n

Se refiere a la toxicidad resultante de una \u00fanica exposici\u00f3n. Las pruebas realizadas en ratones con 108 pigmentos org\u00e1nicos mostraron que su DL50<\/sub>\u00a0superaban todos los 5000 mg\/kg, m\u00e1s que la sal de mesa (aproximadamente 3000 mg\/kg). La UE define las sustancias con una DL50<\/sub>\u00a0por 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

Tabla 1: Pigmentos de toxicidad aguda actualmente prohibidos en el mercado <\/strong><\/strong><\/p>\n\n\n\n

N\u00famero de serie<\/strong><\/strong><\/td>Pigmento<\/strong><\/strong><\/td>N\u00famero de serie<\/strong><\/strong><\/td>Pigmento<\/strong><\/strong><\/td><\/tr>
1<\/td>Basic Amarillo 21<\/td>8<\/td>Naranja \u00e1cida 165<\/td><\/tr>
2<\/td>Rojo b\u00e1sico 12<\/td>9<\/td>Naranja directo 62<\/td><\/tr>
3<\/td>Violeta b\u00e1sico 16<\/td>10<\/td>Tinte Ice Base 20<\/td><\/tr>
4<\/td>Azul b\u00e1sico 3<\/td>11<\/td>Tinte hielo Base 24<\/td><\/tr>
5<\/td>Azul b\u00e1sico 7<\/td>12<\/td>Tinte hielo Base 41<\/td><\/tr>
6<\/td>Azul b\u00e1sico 81<\/td>13<\/td>Ingrain Azul 2:2<\/td><\/tr>
7<\/td>Naranja \u00e1cida 156<\/td>\u00a0<\/td>\u00a0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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

2.2 Toxicidad por exposici\u00f3n repetida<\/strong><\/strong><\/p>\n\n\n\n

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

2.3 Irritaci\u00f3n<\/strong><\/strong><\/p>\n\n\n\n

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

2.4 Alergenicidad<\/strong><\/strong><\/p>\n\n\n\n

Certain pigments may cause skin or respiratory allergies. Allergenic pigments in textiles must be controlled below 0.006%. ETAD identified 27 allergenic pigments (Table 2), including 26 disperse dyes and 1 acid dye; the Oeko-Tex Standard 100 lists 20. Their common characteristics include: predominantly azo or anthraquinone structures, relatively low molecular weight (230\u00a0\u2013 400), presence of strong electron-donating groups such as hydroxyl or amino, and solubility in organic solvents.<\/p>\n\n\n\n

Cuadro 2 Pigmentos alerg\u00e9nicos conocidos en la actualidad <\/strong><\/strong><\/p>\n\n\n\n

N\u00famero de serie<\/strong><\/strong><\/td>Pigmento<\/strong><\/strong><\/td>N\u00famero de serie<\/strong><\/strong><\/td>Pigmento<\/strong><\/strong><\/td><\/tr>
1<\/td>C.I. Disperse Yellow 1<\/td>15<\/td>C.I. Dispersi\u00f3n Azul 1<\/td><\/tr>
2<\/td>C.I. Disperse Yellow 3<\/td>16<\/td>C.I. Dispersi\u00f3n Azul 3<\/td><\/tr>
3<\/td>C.I. Disperse Yellow 9<\/td>17<\/td>C.I. Dispersi\u00f3n Azul 7<\/td><\/tr>
4<\/td>C.I. Disperse Amarillo 39<\/td>18<\/td>C.I. Dispersi\u00f3n Azul 26<\/td><\/tr>
5<\/td>C.I. Disperse Amarillo 49<\/td>19<\/td>C.I. Dispersi\u00f3n Azul 35<\/td><\/tr>
6<\/td>C.I. Dispersi\u00f3n Naranja 1<\/td>20<\/td>C.I. Azul disperso 85<\/td><\/tr>
7<\/td>C.I. Dispersi\u00f3n Naranja 3<\/td>21<\/td>C.I. Dispersi\u00f3n Azul 102<\/td><\/tr>
8<\/td>C.I. Dispersi\u00f3n Naranja 13<\/td>22<\/td>C.I. Dispersi\u00f3n Azul 106<\/td><\/tr>
9<\/td>C.I. Naranja Dispersa 37<\/td>23<\/td>C.I. Dispersi\u00f3n Azul 124<\/td><\/tr>
10<\/td>C.I. Naranja Dispersa 76<\/td>24<\/td>C.I. Dispersi\u00f3n Marr\u00f3n 1<\/td><\/tr>
11<\/td>C.I. Disperse Red 1<\/td>25<\/td>C.I. Dispersi\u00f3n Negro 1<\/td><\/tr>
12<\/td>C.I. Dispersi\u00f3n Rojo 11<\/td>26<\/td>C.I. Disperse Black 2<\/td><\/tr>
13<\/td>C.I. Disperse Red 15<\/td>27<\/td>C.I. \u00c1cido Negro 48<\/td><\/tr>
14<\/td>C.I. Disperse Red 17<\/td>\u00a0<\/td>\u00a0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

2.5 Mutagenicidad<\/strong><\/strong><\/p>\n\n\n\n

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

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

Tabla 3: Resultados de las pruebas de mutagenicidad de los pigmentos org\u00e1nicos mediante el ensayo de Ames <\/strong><\/strong><\/p>\n\n\n\n

Pigmentos \u00a0\u00a0\u00a0<\/strong><\/strong><\/td>\u00cdndice de tinte N\u00famero de estructura<\/strong><\/strong><\/td>Resultados<\/strong><\/strong><\/td>Pigmentos \u00a0\u00a0\u00a0<\/strong><\/strong><\/td>\u00cdndice de tinte N\u00famero de estructura<\/strong><\/strong><\/td>Resultados<\/strong><\/strong><\/td><\/tr>
C.I.Pigment Yellow 1<\/td>11680<\/td>Negativo<\/td>C.I. Pigmento Rojo 49:2<\/td>15630:2<\/td>Negativo<\/td><\/tr>
C.I.Pigment Amarillo 12<\/td>21090<\/td>Negativo<\/td>C.I. Pigmento Rojo 53:1<\/td>15585 1<\/td>Negativo<\/td><\/tr>
C.I.Pigment Amarillo 74<\/td>11741<\/td>Negativo<\/td>C.I. Pigmento Rojo 57:1<\/td>15850 1<\/td>Negativo<\/td><\/tr>
C.I.Pigment Naranja 5<\/td>12075<\/td>Positivo d\u00e9bil<\/td>C.I. Pigmento Rojo 63:1<\/td>158801<\/td>Negativo<\/td><\/tr>
C.I.Pigment Naranja 13<\/td>21110<\/td>Negativo<\/td>C.1. Pigmento Azul 15<\/td>74160<\/td>Negativo<\/td><\/tr>
C.I.Pigment Red 1<\/td>12070<\/td>Positivo d\u00e9bil<\/td>C1. Pigmento azul 15:1<\/td>74160.1<\/td>Negativo<\/td><\/tr>
C.I.Pigment Red 4<\/td>12085<\/td>Negativo<\/td>C1. Pigmento Azul 1512<\/td>74160 2<\/td>Negativo<\/td><\/tr>
C.I.Pigmento Rojo 22<\/td>12815<\/td>Negativo<\/td>C1. Pigmento Azul 15:3<\/td>74160-3<\/td>Negativo<\/td><\/tr>
C.I.Pigmento Rojo 23<\/td>12355<\/td>Negativo<\/td>C1. Pigmento Azul 15:4<\/td>74160\u00a04<\/td>Negativo<\/td><\/tr>
C.I.Pigment Red 48:1<\/td>15865-1<\/td>Negativo<\/td>C.1. Pigmento Verde 7<\/td>74260<\/td>Negativo<\/td><\/tr>
C.I.Pigment Red 48:2<\/td>15865 2<\/td>Negativo<\/td>C.1. Pigmento Verde 36<\/td>74265<\/td>Negativo<\/td><\/tr>
C.I.Pigmento Rojo 49<\/td>15630<\/td>Negativo<\/td>C.1. Pigmento Violeta 19<\/td>73900<\/td>Negativo<\/td><\/tr>
C.I.Pigment Red 49:1<\/td>15630:1<\/td>Negativo<\/td>\u00a0<\/td>\u00a0<\/td>\u00a0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

2.6 Toxicidad cr\u00f3nica y carcinogenicidad<\/strong><\/strong><\/p>\n\n\n\n

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

2.7 Toxicidad acu\u00e1tica y biodegradabilidad<\/strong><\/strong><\/p>\n\n\n\n

ETAD testing indicates that 59% of dyes and pigments exhibit low fish toxicity (LD50 > 100 mg\/L), while only 2% demonstrate high toxicity (LD50 < 1 mg\/L). In bacterial toxicity tests, a small number of dyes inhibit bacterial growth.<\/p>\n\n\n\n

2.8 Irritaci\u00f3n de la piel y las mucosas<\/strong><\/strong><\/p>\n\n\n\n

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

2.9 Impurezas en los pigmentos<\/strong><\/p>\n\n\n\n

- Trazas de aminas arom\u00e1ticas:<\/strong>\u00a0Los 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

- Trazas de metales pesados:<\/strong>\u00a0La 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

- 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

In summary, organic pigments exhibit no acute toxicity, repeated-dose toxicity, significant mutagenicity, or carcinogenicity under conventional conditions. Germany\u2019s 1994 ban applies only to dyes, not organic pigments. However, attention must still be paid to harmful aromatic amines in production auxiliaries, additives, and raw materials. Additionally, monitor varieties prone to decomposing harmful substances at high temperatures (e.g., bichlorobenzidine-based pigments) and byproducts like dioxins that may form during wastewater treatment.<\/p>","protected":false},"excerpt":{"rendered":"

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 […]<\/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":"\nPigments & 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. Depending on the region and product type, relevant requirements may target the pigments themselves, the plastic materials, or encompass general provisions.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/chromeclair.com\/es\/2025-pigments-toxicology\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pigments & Toxicology\" \/>\n<meta property=\"og: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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