Source: EURLEX
Language: es
Format: md

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| European flag | Diario Oficial  de la Unión Europea | ES  Serie L |

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|  | 2024/2492 | 24.9.2024 |

REGLAMENTO (UE) 2024/2492 DE LA COMISIÓN

de 23 de septiembre de 2024

que modifica el Reglamento (CE) n.o 440/2008 en lo que respecta a los métodos de ensayo, con vistas a su adaptación al progreso técnico

(Texto pertinente a efectos del EEE)

LA COMISIÓN EUROPEA,

Visto el Tratado de Funcionamiento de la Unión Europea,

Visto el Reglamento (CE) n.o 1907/2006 del Parlamento Europeo y del Consejo, de 18 de diciembre de 2006, relativo al registro, la evaluación, la autorización y la restricción de las sustancias y mezclas químicas (REACH), por el que se crea la Agencia Europea de Sustancias y Mezclas Químicas, se modifica la Directiva 1999/45/CE y se derogan el Reglamento (CEE) n.o 793/93 del Consejo y el Reglamento (CE) n.o 1488/94 de la Comisión, así como la Directiva 76/769/CEE del Consejo y las Directivas 91/155/CEE, 93/67/CEE, 93/105/CE y 2000/21/CE de la Comisión [(1)](#ntr1-L_202402492ES.000101-E0001), y en particular su artículo 13, apartado 2,

Considerando lo siguiente:

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| (1) | El Reglamento (CE) n.o 440/2008 de la Comisión [(2)](#ntr2-L_202402492ES.000101-E0002) contiene, en su anexo, los métodos de ensayo que se han considerado adecuados para generar información acerca de las propiedades fisicoquímicas, toxicológicas y ecotoxicológicas de las sustancias químicas a efectos del Reglamento (CE) n.o 1907/2006. |

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| (2) | La Organización para la Cooperación y el Desarrollo Económico (OCDE) elabora directrices de ensayo armonizadas y acordadas a nivel internacional para los ensayos de sustancias y mezclas químicas con fines normativos. La OCDE publica periódicamente directrices de ensayos nuevas y revisadas, teniendo en cuenta el progreso científico en este ámbito. |

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| (3) | A fin de mantener actualizado el Reglamento (CE) n.o 440/2008 a tenor del progreso técnico y reducir el número de animales utilizados en los experimentos, y de conformidad con la Directiva 2010/63/UE del Parlamento Europeo y del Consejo [(3)](#ntr3-L_202402492ES.000101-E0003), deben añadirse siete métodos de ensayo al anexo del Reglamento (CE) n.o 440/2008: un método de ensayo nuevo relativo a las propiedades fisicoquímicas básicas [(4)](#ntr4-L_202402492ES.000101-E0004), un método de ensayo nuevo y dos actualizados para la determinación de los efectos sobre la salud humana de los ensayos in vitro relativos a la inmunotoxicidad y a la sensibilización cutánea [(5)](#ntr5-L_202402492ES.000101-E0005), y tres métodos de ensayo actualizados para la evaluación de la ecotoxicidad [(6)](#ntr6-L_202402492ES.000101-E0006). |

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| (4) | Además, la OCDE publicó en 2023 nuevas versiones corregidas de los siguientes métodos de ensayo, incluidas en el Reglamento (CE) n.o 440/2008: Directriz de ensayo 125 de la OCDE [(7)](#ntr7-L_202402492ES.000101-E0007); Directriz de ensayo 316 de la OCDE [(8)](#ntr8-L_202402492ES.000101-E0008); Directriz de ensayo 405 de la OCDE [(9)](#ntr9-L_202402492ES.000101-E0009); Directriz de ensayo 437 de la OCDE [(10)](#ntr10-L_202402492ES.000101-E0010); Directriz de ensayo 438 de la OCDE [(11)](#ntr11-L_202402492ES.000101-E0011); Directriz de ensayo 456 de la OCDE [(12)](#ntr12-L_202402492ES.000101-E0012); Directriz de ensayo 458 de la OCDE [(13)](#ntr13-L_202402492ES.000101-E0013); Directriz de ensayo 460 de la OCDE [(14)](#ntr14-L_202402492ES.000101-E0014); Directriz de ensayo 487 de la OCDE [(15)](#ntr15-L_202402492ES.000101-E0015); Directriz de ensayo 491 de la OCDE [(16)](#ntr16-L_202402492ES.000101-E0016); Directriz de ensayo 492 de la OCDE [(17)](#ntr17-L_202402492ES.000101-E0017); Directriz de ensayo 496 de la OCDE [(18)](#ntr18-L_202402492ES.000101-E0018); Directriz de ensayo 497 de la OCDE [(19)](#ntr19-L_202402492ES.000101-E0019); y Directriz de ensayo 498 de la OCDE [(20)](#ntr20-L_202402492ES.000101-E0020). Procede, por tanto, suprimir de las partes B y C del anexo del Reglamento (CE) n.o 440/2008 las versiones obsoletas de las descripciones completas de dichos métodos de ensayo. |

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| (5) | Para lograr una mejor armonización con la legislación conexa, en particular el Reglamento (CE) n.o 1272/2008 del Parlamento Europeo y del Consejo [(21)](#ntr21-L_202402492ES.000101-E0021), debe reestructurarse la lista de los métodos de ensayo para las propiedades fisicoquímicas que figura en la parte 0, cuadro 1, del anexo del Reglamento (CE) n.o 440/2008 y deben añadirse a ella los siguientes métodos de ensayo: ASTM D4359-90: Standard Test Method for Determining whether a Material Is a Liquid or a Solid; Test for determining fluidity according to section 2.3.4 of Annex A of the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR); Calorimetric test methods according to section 20.3.3.3 of Part II of the UN Manual of Tests and Criteria; DIN 66137-2: Determination of solid state density-Part 2: Gas pycnometry; ISO 12154: Determination of density by volumetric displacement-Skeleton density by gas pycnometry; ISO/TR 14187:2020: Surface chemical analysis-Characterization of nanostructured materials; EN 17199-1:2019: Workplace exposure-Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles; EN 15051-1: Workplace exposure-Measurement of the dustiness of bulk materials-Part 1: Requirements and choice of test methods; EN 15051-2: Workplace exposure-Measurement of the dustiness of bulk materials-Part 2: Rotating drum method; y EN 15051-3: Workplace exposure-Measurement of the dustiness of bulk materials-Part 3: Continuous drop method. Deben añadirse asimismo los siguientes métodos de ensayo, conforme a lo dispuesto en el anexo I, parte 2, del Reglamento (CE) n.o 1272/2008 del Parlamento Europeo y del Consejo: método de ensayo para los gases pirofóricos [(22)](#ntr22-L_202402492ES.000101-E0022); método de ensayo para la inestabilidad química [(23)](#ntr23-L_202402492ES.000101-E0023); métodos de ensayo para determinar el punto inicial de ebullición de líquidos inflamables [(24)](#ntr24-L_202402492ES.000101-E0024); métodos de ensayo para determinar el punto de inflamación de líquidos inflamables [(25)](#ntr25-L_202402492ES.000101-E0025); método de ensayo para las sustancias que reaccionan espontáneamente [(26)](#ntr26-L_202402492ES.000101-E0026); métodos de ensayo para los peróxidos orgánicos [(27)](#ntr27-L_202402492ES.000101-E0027); método de ensayo para las sustancias corrosivas para los metales [(28)](#ntr28-L_202402492ES.000101-E0028); y métodos de ensayo para los explosivos desensibilizados [(29)](#ntr29-L_202402492ES.000101-E0029). |

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| (6) | Procede, por tanto, modificar el Reglamento (CE) n.o 440/2008 en consecuencia. |

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| (7) | Se ha consultado a las partes interesadas pertinentes sobre la modificación propuesta. |

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| (8) | Las medidas previstas en el presente Reglamento se ajustan al dictamen del Comité creado en virtud del artículo 133, apartado 1, del Reglamento (CE) n.o 1907/2006. |

HA ADOPTADO EL PRESENTE REGLAMENTO:

Artículo 1

Se modifica el anexo del Reglamento (CE) n.o 440/2008 de conformidad con el anexo del presente Reglamento.

Artículo 2

El presente Reglamento entrará en vigor a los veinte días de su publicación en el Diario Oficial de la Unión Europea.

El presente Reglamento será obligatorio en todos sus elementos y directamente aplicable en cada Estado miembro.

Hecho en Bruselas, el 23 de septiembre de 2024.

Por la Comisión

La Presidenta

Ursula VON DER LEYEN

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ANEXO

El anexo del Reglamento (CE) n.o 440/2008 se modifica como sigue:

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| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1) | La parte 0 se modifica como sigue:   |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | a) | el cuadro 1 se sustituye por el texto siguiente:  «CUADRO 1: MÉTODOS DE ENSAYO PARA LAS PROPIEDADES FISICOQUÍMICAS DE LA SUSTANCIA   |  |  |  | | --- | --- | --- | | Propiedades fisicoquímicas básicas | | | | Parámetro | Método de ensayo | Capítulo correspondiente en la parte A del presente anexo, que contiene la descripción completa del método de ensayo (los números entre paréntesis indican que la descripción completa del método de ensayo ha sido suprimida de la parte A; casilla vacía: no hay ningún método de ensayo correspondiente en la parte A del presente anexo) | | Punto de fusión/punto de congelación | OECD Test Guideline 102: Melting Point/Melting Range (1995) | A.1. | | ASTM D4359-90: Standard Test Method for Determining whether a Material Is a Liquid or a Solid |  | | Test for determining fluidity according to section 2.3.4 of Annex A of the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) |  | | Punto de ebullición | OECD Test Guideline 103: Boiling point (1995) | A.2. | | Test methods according to Table 2.6.4 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |  | | Inflamabilidad | EN 15188:2020 – Determination of the spontaneous ignition behaviour of dust accumulations |  | | Límite superior e inferior de explosividad | Test methods according to section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 (ISO 10156 and EN 1839) |  | | Punto de inflamación | Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |  | | Temperatura de autoinflamabilidad (líquidos, gases) | ISO/IEC 80079-20-1:2017 – Explosive atmospheres-Part 20-1: Material characteristics for gas and vapour classification-Test methods and data |  | | Temperatura de descomposición | Calorimetric test methods according to section 20.3.3.3 of Part II of the UN Manual of Tests and Criteria |  | | Test Series H, part II, section 28, of the UN Manual of Tests and Criteria for the self-accelerating decomposition temperature (SADT) (with reference to a specific package) |  | | pH | OECD Test Guideline 122: Determination of pH, Acidity and Alkalinity (2013) |  | | Viscosidad cinemática | OECD Test Guideline 114: Viscosity of Liquids (2012) |  | | Hidrosolubilidad | OECD Test Guideline 105: Water Solubility (1995) | A.6. | | Coeficiente de reparto  n-octanol/agua | OECD Test Guideline 107: Partition Coefficient (n-octanol/water): Shake-Flask Method (1995) | (A.8.) | | OECD Test Guideline 123: Partition Coefficient (1-Octanol/Water): Slow-Stirring Method (2022) | A.23. | | OECD Test Guideline 117: Partition Coefficient (n-octanol/water): HPLC Method (2022) | A.24. | | Presión de vapor | OECD Test Guideline 104: Vapour Pressure (2006) | (A.4.) | | Densidad/densidad relativa | OECD Test Guideline 109: Density of Liquids and Solids (2012) | (A.3.) | | DIN 66137-2-Determination of solid state density-Part 2: Gas pycnometry | | ISO 12154-Determination of density by volumetric displacement-Skeleton density by gas pycnometry | | Características de las partículas | EU test method A.22. Length Weighted Geometric Mean Diameter of Fibres | A.22. | | ISO 21501-Determination of Particle Size Distribution-Single Particle Light Interaction Methods |  | | OECD Test Guideline 124: Determination of the Volume Specific Surface Area of Manufactured Nanomaterials (2022) |  | | OECD Test Guideline 125: Particle Size and Particle Size Distribution of Nanomaterials (2023) |  | | ISO/TR 14187:2020-Surface chemical analysis-Characterization of nanostructured materials | | Pulverulencia (para las nanoformas de una sustancia) | EN 17199-1:2019 – Workplace exposure-Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles |  | | EN 15051-1: Workplace exposure-Measurement of the dustiness of bulk materials-Part 1: Requirements and choice of test methods | | EN 15051-2: Workplace exposure-Measurement of the dustiness of bulk materials-Part 2: Rotating drum method | | EN 15051-3: Workplace exposure-Measurement of the dustiness of bulk materials-Part 3: Continuous drop method | | Tensión superficial | OECD Test Guideline 115: Surface Tension of Aqueous Solutions (1995) | A.5. | | Constante de disociación | OECD Test Guideline 112: Dissociation Constants in Water (1981) | A.25. | | Hidrofobicidad | OECD Test Guideline 126: Determination of the Hydrophobicity Index of Manufactured Nanomaterials Through an Affinity Measurement (2023) |  | | Propiedades relativas a peligros fisicoquímicos | | | | Explosivos | Test methods for explosives according to section 2.1.2.1. and 2.1.2.3. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | EU Test method A.14 Explosive Properties | A.14. | | Gases inflamables | Test method for the fundamental burning velocity according to section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Test method for pyrophoric gases according to section 2.2.4.2. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Test method for the chemical instability according to section 2.2.4.4. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Gases comburentes | Test method for oxidising gases according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Líquidos inflamables | Test method for the sustained combustibility according to section 2.6.4.5. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Test methods for determining the flash point of flammable liquids according to section 2.6.4.4. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 | | Sólidos inflamables | Test method for flammable solids according to section 2.7.2.3. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Sustancias que reaccionan espontáneamente | Test method for self-reactive substances according to section 2.8.4.1. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Líquidos pirofóricos | Test method for pyrophoric liquids according to section 2.9.2.1. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Sólidos pirofóricos | Test method for pyrophoric solids according to section 2.10.2.1. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008, |  | | Sustancias que se calientan espontáneamente | Test method for self-heating substances according to section 2.11.2.2 of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Sustancias que, en contacto con el agua, desprenden gases inflamables | Test method for substances which in contact with water emit flammable gases according to section 2.12.2.1. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Líquidos comburentes | Test method for oxidising liquids according to section 2.13.2.1. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Sólidos comburentes | Test method for oxidising solids according to section 2.14.2.1. of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Peróxidos orgánicos | Test methods according to section 2.15.4.1 of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Corrosivos para los metales | Test method for substances corrosive to metals according to section 2.16.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |  | | Explosivos insensibilizados | Test methods according to section 2.17.2.1 (b) and (c) and according to section 2.17.2.2 of Annex I, Part 2 of Regulation (EC) n.o 1272/2008 |  | | Propiedades de los polímeros | OECD Test Guideline 118: Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation Chromatography (1996) | A.18. | | OECD Test Guideline 119: Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation Chromatography (1996) | A.19. | | OECD Test Guideline 120: Solution/Extraction Behaviour of Polymers in Water (2000) | (A.20.)», | |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | b) | el cuadro 2 se modifica como sigue:   |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | i) | la entrada «Lesiones oculares graves o irritación ocular» se sustituye por el texto siguiente:   |  |  |  | | --- | --- | --- | | «Lesiones oculares graves o irritación ocular | In vitro: | | | OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023) | (B.47.) | | OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023) | (B.48.) | | OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (2023) | (B.61.) | | OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023) | (B.68.) | | OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage (2023) | (B.69.) | | OECD Test Guideline 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification (2022) |  | | OECD Test Guideline 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage (2021) |  | | OECD Test Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023) |  | | OECD Test Guideline 467: Defined Approaches for Serious Eye Damage and Eye Irritation (2022) |  | | In vivo: | | | OECD Test Guideline 405: Acute Eye Irritation/Corrosion (2023) | (B.5.)», | |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ii) | en la entrada «Sensibilización cutánea», la sección «In vitro» se sustituye por el texto siguiente:   |  |  | | --- | --- | | «In vitro: | | | OECD Test Guideline 442C: In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2023) | (B.59.) | | OECD Test Guideline 442D: In Vitro Skin Sensitisation Assays Addressing the AOP Key Event on Keratinocyte Activation (2022) | (B.60.) | | OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation (2023) | (B.71.)» | | OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2023), |  | |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | iii) | en la entrada «Mutagenicidad», la fila siguiente:   |  |  |  | | --- | --- | --- | |  |  | | | «OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2016) | B.49» |   se sustituye por el texto siguiente:   |  |  |  | | --- | --- | --- | |  |  | | | «OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2023) | (B.49.)», | |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | iv) | en la entrada «Propiedades de alteración endocrina», las filas siguientes:   |  |  |  | | --- | --- | --- | |  |  | | | «OECD Test Guideline 456: H295R Steroidogenesis Assay (2022) | B.57.» | | OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2020) |  |   se sustituyen por el texto siguiente:   |  |  |  | | --- | --- | --- | |  |  | | | «OECD Test Guideline 456: H295R Steroidogenesis Assay (2023) | (B.57.)» | | OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2023), |  | |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | v) | en la entrada «Fototoxicidad», la fila siguiente:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 498: In Vitro Phototoxicity Test Method Using the Reconstructed Human Epidermis (RhE) (2021)» |  |   se sustituye por el texto siguiente:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 498: In Vitro Phototoxicity Reconstructed Human Epidermis Phototoxicity test method (2023)», |  | |  |  |  |  |  |  | | --- | --- | --- | --- | --- | | vi) | después de la sección «Fototoxicidad», se inserta la entrada siguiente:   |  |  |  | | --- | --- | --- | | «Inmunotoxicidad | OECD Test Guideline 444A: In vitro immunotoxicity IL-2 Luc assay (2023)», |  | | |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | c) | el cuadro 3 se modifica como sigue:   |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | i) | en la entrada «Degradación», la fila siguiente:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2008)» |  |   se sustituye por el texto siguiente:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2023)»; |  | |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ii) | en la entrada «Efectos en organismos de sedimentos», las filas siguientes:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment (2004) | C.27. | | OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water (2004) | C.28.» |   se sustituyen por el texto siguiente:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Test Using Spiked Sediment (2023) | (C.27.) | | OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Test Using Spiked Water (2023) | (C.28.)» | |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | iii) | en la entrada «Propiedades de alteración endocrina», la fila siguiente:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 240: Medaka Extended OneGeneration Reproduction Test (MEOGRT) (2015) | C.52.» |   se sustituye por el texto siguiente:   |  |  |  | | --- | --- | --- | |  | «OECD Test Guideline 240: Medaka Extended One Generation Reproduction Test (MEOGRT) (2023) | (C.52.)» | | | |

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| 2) | En la parte B, el texto que figura debajo del encabezamiento de cada uno de los capítulos B.49 y B.57 se sustituye por el texto siguiente: «Se suprime la descripción completa de este método de ensayo. El método de ensayo internacional equivalente figura en el cuadro 2 de la parte 0.». |

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| 3) | En la parte C, el texto que figura debajo del encabezamiento de cada uno de los capítulos C.27, C.28 y C.52 se sustituye por el texto siguiente: «Se suprime la descripción completa de este método de ensayo. El método de ensayo internacional equivalente figura en el cuadro 3 de la parte 0.». |

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ELI: http://data.europa.eu/eli/reg/2024/2492/oj

ISSN 1977-0685 (electronic edition)

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