6.3.2023   

GA

Iris Oifigiúil an Aontais Eorpaigh

L 68/37

RIALACHÁN (AE) 2023/464 ÓN gCOIMISIÚN

an 3 Márta 2023

lena leasaítear, chun críoch a hoiriúnaithe don dul chun cinn teicniúil, an Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 lena leagtar síos modhanna tástála de bhun Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle maidir le Clárú, Meastóireacht, Údarú agus Srianadh Ceimiceán

(Téacs atá ábhartha maidir le LEE)

TÁ AN COIMISIÚN EORPACH,

Ag féachaint don Chonradh ar Fheidhmiú an Aontais Eorpaigh,

Ag féachaint do Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle an 18 Nollaig 2006 maidir le Clárú, Meastóireacht, Údarú agus Srianadh Ceimiceán (REACH), lena mbunaítear Gníomhaireacht Eorpach Ceimiceán, lena leasaítear Treoir 1999/45/CE agus lena n-aisghairtear Rialachán (CEE) Uimh. 793/93 ón gComhairle agus Rialachán (CE) Uimh. 1488/94 ón gCoimisiún, chomh maith le Treoir 76/769/CEE ón gComhairle agus Treoracha 91/155/CEE, 93/67/CEE, 93/105/CE agus 2000/21/CE ón gCoimisiún (1), agus go háirithe Airteagal 13(2) agus (3) de,

De bharr an mhéid seo a leanas:

(1)

Le hAirteagal 13(3) de Rialachán (CE) Uimh. 1907/2006, i gcás ina gceanglaítear go ghintear faisnéis le tástálacha ar shubstaintí faoi airíonna intreacha substaintí, foráiltear go bhfuil na tástálacha sin le déanamh i gcomhréir leis na modhanna tástála a leagtar síos i Rialachán ón gCoimisiún nó i gcomhréir le modhanna tástála idirnáisiúnta eile a n-aithníonn an Coimisiún nó an Ghníomhaireacht Eorpach Ceimiceán go bhfuil siad iomchuí.

(2)

San Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 ón gCoimisiún (2), tá modhanna tástála a aithnítear mar mhodhanna iomchuí chun faisnéis a ghiniúint maidir leis na hairíonna fisiciceimiceacha, tocsaineolaíocha agus éiceathocsaineolaíocha de cheimiceáin chun críoch Rialachán (CE) Uimh. 1907/2006.

(3)

Tá an chuid is mó de na modhanna tástála san Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 coibhéiseach le modhannaatá comhaontaithe agus a bhfuil glacadh leo go hidirnáisiúnta (amhail treoirlínte tástála na hEagraíochta um Chomhar agus Forbairt Eacnamaíochta). Déantar athbhreithniú ar na modhanna sin go minic agus athraítear iad ionas go dtagann siad le staid na heolaíochta.

(4)

Bhí moill ar oiriúnú an Rialacháin sin toisc go ndearnadh athrá ar thuairisc iomlán na modhanna sin atá comhaontaithe agus a bhfuil glacadh leo go hidirnáisiúnta san Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 chun iad a thabhairt isteach i reachtaíocht an Aontais. Dá réir sin, na modhanna tástála a leagtar síos san Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008, ní bhíonn siad ailínithe go minic leis an leagan is cothroime le dáta de na modhanna idirnáisiúnta comhfhreagracha. Ar ábhar gaolmhar, ní chuirtear modhanna tástála idirnáisiúnta nua le Rialachán (CE) Uimh. 440/2008 ach amháin tar éis tréimhse fhada ama.

(5)

Dá bharr sin, cruthaíodh éiginnteacht le haghaidh cláraithe faoi Rialachán (CE) Uimh. 1907/2006, agus le haghaidh sealbhóirí dualgais faoi reachtaíocht eile an Aontais, maidir le céard iad na modhanna ar cheart iad a úsáid chun sonraí a ghiniúint chun críocha an Rialacháin sin agus chun críoch reachtaíochta eile. Le hAirteagal 13(2) de Rialachán (CE) Uimh. 1907/2006 foráiltear go bhfuil athbhreithnithe rialta le déanamh ar mhodhanna agus go bhfuil na modhanna sin le feabhsú d’fhonn tástáil ar ainmhithe veirteabracha agus an líon ainmhithe lena mbaineann a laghdú, agus go bhfuil an Coimisiún le togra a dhéanamh, más iomchuí, a luaithe agus is féidir chun Rialachán (CE) Uimh. 440/2008 a leasú, chun tástáil ar ainmhithe a laghdú, a bheachtú, nó chun rud éigin a chur ina hionad. Thairis sin, de bharr Airteagal 13 de Threoir 2010/63/AE ó Pharlaimint na hEorpa agus ón gComhairle (3) maidir le cosaint ainmhithe a úsáidtear chun críoch eolaíoch, tá sé ina oibleagáid dhlíthiúil san Aontas modh malartach a úsáid nach bhfuil ainmhí beo le húsáid ann, seachas modh ina n-úsáidtear ainmhí, a luaithe a aithnítear modh den chineál sin faoi reachtaíocht an Aontais. Dá mbeadh aon mhoill ar an bpróiseas chun modhanna nua malartacha a thabhairt isteach i Rialachán (CE) Uimh. 440/2008, d’fhéadfaí bac a chur ar ghlacadh tráthúil na modhanna sin a luaithe a ghlacfar ar leibhéal idirnáisiúnta iad dá bharr sin.

(6)

Sa Chinneadh i gcás 23/2018/SRS, mhol an Ombudsman Eorpach don Choimisiún dlús a chur lena iarrachtaí an próiseas a shimpliú agus a bhrostú maidir le modhanna tástála nua malartacha a thabhairt isteach faoi Rialachán (CE) Uimh. 440/2008. Ina theannta sin, i rún 2021/2784 (RSP) ó Pharlaimint na hEorpa an 16 Meán Fómhair 2021 maidir le pleananna agus gníomhaíochtaí chun dlús a chur leis an aistriú chuig an nuálaíocht gan ainmhithe a úsáid i réimsí an taighde, na tástála rialála agus an oideachais, mheabhraigh Parlaimint na hEorpa go gceanglaítear le hAirteagal 13 de Rialachán (CE) Uimh. 1907/2006 go ndéantar na ceanglais maidir le modhanna tástála a thabhairt cothrom le dáta a luaithe a bheidh fáil ar mhodhanna neamhainmhithe.

(7)

Dá bhrí sin, chun a áirithiú go soláthraítear modhanna tástála cearta atá cothrom le dáta le Rialachán (CE) Uimh. 440/2008 ar modhanna tástála iomchuí iad chun faisnéis a ghiniúint faoi Rialachán (CE) Uimh. 1907/2006, ba cheart tábla a bheith san Iarscríbhinn a ghabhann leis an Rialachán sin, lena dtugtar liosta cuimsitheach na modhanna sin le tagairt don mhodh tástála idirnáisiúnta ábhartha. Maidir le tagairt do mhodh tástála idirnáisiúnta a bheith sa tábla, ba cheart é sin a mheas mar aitheantas ón gCoimisiún i leith an mhodha sin chun críocha Airteagal 13(3) de Rialachán (CE) Uimh. 1907/2006.

(8)

Tuairiscí iomlána ar mhodhanna tástála i gCodanna A, B agus C den Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 nach gcomhfhreagraíonn don leagan is déanaí den mhodh tástála idirnáisiúnta, ba cheart na tuairiscí sin a scriosadh ón Iarscríbhinn sin ionas nach ndéantar tástálacha de réir prótacail nach bhfuil faisnéis eolaíoch úrscothach ina bunús leo.

(9)

Modhanna tástála áirithe a leagtar amach san Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008, chomh maith lena modhanna tástála idirnáisiúnta comhfhreagracha, ní mheastar a thuilleadh gurb iomchuí iad chun faisnéis nua a ghiniúint faoi Rialachán (CE) Uimh. 1907/2006. Maidir leis na modhanna tástála B.22. Tástáil le haghaidh sócháin mharfaigh cheannasaigh i gcreimirí; B.25. Tástáil tras-suíomh inoidhreachta i lucha; B.34. Staidéar tocsaineachta ar atáirgeadh aonghlúine; B.35. Staidéar tocsaineachta ar atáirgeadh thar dhá ghlúin; B.39. Tástáil sintéise DNA neamhsceidealta (UDS) ina n-úsáidtear cealla ae mamacha in vivo; agus C.15. Éisc, Tástáil tocsaineachta ghearrthéarmach ag staid an tsutha agus ag staid an ghilidín saic; ba cheart iad a scriosadh ón Iarscríbhinn sin, dá bhrí sin, agus níor cheart tagairt a dhéanamh dóibh le haon iontráil sa tábla a leagtar amach san Iarscríbhinn sin.

(10)

Dá bhrí sin, ba cheart Rialachán (CE) Uimh. 440/2008 a leasú dá réir sin.

(11)

Na bearta dá bhforáiltear sa Rialachán seo, tá siad i gcomhréir leis an tuairim ón gCoiste arna bhunú faoi Airteagal 133 de Rialachán (CE) Uimh. 1907/2006,

TAR ÉIS AN RIALACHÁN SEO A GHLACADH:

Airteagal 1

Leasaítear an Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 i gcomhréir leis an Iarscríbhinn a ghabhann leis an Rialachán seo.

Airteagal 2

Tiocfaidh an Rialachán seo i bhfeidhm an fichiú lá tar éis lá a fhoilsithe in Iris Oifigiúil an Aontais Eorpaigh.

Beidh an Rialachán seo ina cheangal go huile agus go hiomlán agus beidh sé infheidhme go díreach i ngach Ballstát.

Arna dhéanamh sa Bhruiséil, an 3 Márta 2023.

Thar ceann an Choimisiúin

An tUachtarán

Ursula VON DER LEYEN

(1)  IO L 396, 30.12.2006, lch. 1

(2)  Rialachán (CE) Uimh. 440/2008 ón gCoimisiún an 30 Bealtaine 2008 lena leagtar síos modhanna tástála de bhun Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle maidir le Clárú, Meastóireacht, Údarú agus Srianadh Ceimiceán (REACH) (IO L 142, 31.5.2008, lch. 1).

(3)  Treoir 2010/63/AE ó Pharlaimint na hEorpa agus ón gComhairle an 22 Meán Fómhair 2010 maidir le cosaint ainmhithe a úsáidtear chun críoch eolaíoch (IO L 276, 20.10.2010, lch. 33).

IARSCRÍBHINN

Leasaítear an Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 mar a leanas:

(1)

roimh Chuid A, cuirtear isteach an Chuid 0 seo a leanas

“Cuid 0

Modhanna tástála idirnáisiúnta a aithnítear a bheith iomchuí chun faisnéis a ghiniúint faoi airíonna intreacha substaintí chun críocha Rialachán (CE) Uimh. 1907/2006

TÁBLA 1: MODHANNA TÁSTÁLA LE hAGHAIDH AIRÍONNA FISICEIMICEACHA NA SUBSTAINTE

Críochphointe

Modh tástála

Caibidil chomhfhreagrach i gCuid A den Iarscríbhinn seo, ina bhfuil tuairisc iomlán ar an modh tástála (léirítear leis na huimhreacha atá idir lúibíní gur scriosadh tuairisc iomlán an mhodha tástála ó Chuid A; cill fholamh: gan modh tástála comhfhreagrach i gCuid A den Iarscríbhinn seo)

Leáphointe/reophointe

OECD Test Guideline 102: Melting Point/Melting Range (1995)

A.1.

Fiuchphointe

OECD Test Guideline 103: Boiling point (1995)

A.2.

Dlús

OECD Test Guideline 109: Density of Liquids and Solids (2012)

(A.3.)

Galbhrú

OECD Test Guideline 104: Vapour Pressure (2006)

(A.4)

Teannas dromchla

OECD Test Guideline 115: Surface Tension of Aqueous Solutions (1995)

A.5.

Tuaslagthacht an uisce

OECD Test Guideline 105: Water Solubility (1995)

A.6.

Comhéifeacht rannach ochtanól/uisce

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.

Tairiseach díthiomsúcháin

OECD Test Guideline 112: Dissociation Constants in Water. (1981)

A.25.

Slaodacht

OECD Test Guideline 114: Viscosity of Liquids (2012)

 

Splancphointe

Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Íosteorainn agus uasteorainn sophléascachta

EN 1839:2017 – Determination of the explosion limits and the limiting oxygen concentration (LOC) for flammable gases and vapours

 

Inadhainteacht

Test methods according to section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Test L.2: sustained combustibility test, Part III, section 32 of the UN RTDG Manual of Tests and Criteria

 

Test N.1: test method for readily combustible solids, Part III, sub-section 33.2.4 of the UN RTDG Manual of Tests and Criteria

 

Test N.5: test method for substances which in contact with water emit flammable gases, Part III, sub-section 33.5.4 of the UN RTDG Manual of Tests and Criteria

 

Teocht féinadhainte (solaid)

Test N.4: test method for self-heating substances, Part III, sub-section 33.4.6 of the UN RTDG Manual of Tests and Criteria

 

EN 15188:2020 – Determination of the spontanous ignition behaviour of dust accumulations

 

Teocht uathadhainte (leachtanna, gáis)

ISO/IEC 80079-20-1:2017 – Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data

 

Teocht fhéinluathaithe

Test Series H, part II, section 28, of the UN RTDG Manual of Tests and Criteria

 

Airíonna pléascacha

Test methods according to Test series 1-3, Part I, sections 11-13 of the UN RTDG Manual of Tests and Criteria

 

EU Test method A.14 Explosive Properties

A.14

Airíonna ocsaídiúcháin

Test method according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Test O.2: test for oxidizing liquids, Part III, sub-section 34.4.2 of the UN RTDG Manual of Tests and Criteria

 

Test O.1: Test for oxidizing solids, Part III, sub-section 34.4.1 of the UN RTDG Manual of Tests and Criteria

 

Test O.3 Gravimetric test for oxidizing solids, Part III, sub-section 34.4 3 of the UN RTDG Manual of Tests and Criteria

 

Pireafóracht

Test N.3: test method for pyrophoric liquids, Part III, sub-section 33.3.1.5 of the UN RTDG Manual of Tests and Criteria

 

Test N.2: test method for pyrophoric solids, Part III, sub-section 33.3.1.4 of the UN RTDG Manual of Tests and Criteria

 

Gráinnmhéadracht/saintréithe cáithníní

EU test method A.22. Length Weighted Geometric Mean Diameter of Fibres

A.22.

ISO 13318 - Determination of Particle Size Distribution by Centrifugal Liquid Sedimentation Methods

 

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 (2022)

 

pH

OECD Test Guideline 122: Determination of pH, Acidity and Alkalinity (2013)

 

Airíonna polaiméirí

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.)

TÁBLA 2: MODHANNA TÁSTÁLA LE hAGHAIDH AIRÍONNA TOCSAINEOLAÍOCHA

Críochphointe

Modh tástála

Caibidil chomhfhreagrach i gCuid B den Iarscríbhinn seo, ina bhfuil tuairisc iomlán ar an modh tástála (léirítear leis na huimhreacha atá idir lúibíní gur scriosadh caibidil ó Chuid B ina raibh an tuairisc iomlán ar an modh tástála; cill fholamh: níl modh tástála AE comhfhreagrach i gCuid B den Iarscríbhinn seo)

Creimeadh/greannú craicinn

In vitro:

OECD Test Guideline 430: In vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER) (2015)

B.40.

OECD Test Guideline 431: In vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test Method (2019)

(B.40bis.)

OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion (2015)

B.65.

OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method (2021)

(B.46.)

In vivo:

OECD Test Guideline 404: Acute Dermal Irritation/Corrosion (2015)

B.4.

Damáiste/greannú tromchúiseach súile

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 (2020)

(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 (2018)

(B.48.)

OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (2017)

(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 (2020)

(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 (2019)

(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 (2019)

 

OECD Test Guideline 467: Defined Approaches for Serious Eye Damage and Eye Irritation (2022)

 

In vivo:

OECD Test Guideline 405: Acute Eye Irritation/Corrosion (2021)

(B.5.)

Íogrú craicinn

In vitro:

OECD Test Guideline 442C: In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA) (2022)

(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 (2022)

(B.71.)

OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2021)

 

In vivo:

OECD Test Guideline 429: Skin Sensitisation - Local Lymph Node Assay (2010)

B.42.

OECD Test Guideline 442A: Skin Sensitisation - Local Lymph Node Assay: DA (2010)

B.50.

OECD Test Guideline 442B: Skin Sensitisation - Local Lymph Node Assay: BrdU-ELISA or –FCM (2018)

(B.51.)

OECD Test Guideline 406: Skin Sensitisation Guinea Pig

Maximisation Test and Buehler Test (2022)

(B.6.)

Só-ghineacht

In vitro:

OECD Test Guideline 471: Bacterial Reverse Mutation Test (2020)

(B.13./14.)

OECD Test Guideline 476: In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt Genes (2016)

(B.17.)

OECD Test Guideline 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene (2016)

B.67.

OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test (2016)

B.10.

OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2016)

B.49.

In vivo:

OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test (2016)

B.11.

OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test (2016)

B.12.

OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test (2016)

B.23.

OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays (2022)

(B.58.)

OECD Test Guideline 489: In Vivo Mammalian Alkaline Comet Assay (2016)

B.62.

OECD Test Guideline 470: Mammalian Erythrocyte Pig-a Gene mutation Assay (2022)

 

Géarthocsaineacht

Oral:

OECD Test Guideline 420: Acute Oral Toxicity: Fixed Dose Procedure (2002)

B.1 bis.

OECD Test Guideline 423: Acute Oral Toxicity: Acute Toxic Class Method (2002)

B.1 tris.

OECD Test Guideline 425: Acute Oral Toxicity: Up-and-Down Procedure (2022)

 

Dermal:

OECD Test Guideline 402: Acute Dermal Toxicity - Fixed Dose Procedure (2017)

(B.3.)

Inhalation:

OECD Test Guideline 403: Acute Inhalation Toxicity (2009)

B.2.

OECD Test Guideline 436: Acute Inhalation Toxicity - Acute Toxic Class Method (2009)

B.52.

OECD Test Guideline 433: Acute Inhalation Toxicity: Fixed Concentration Procedure (2018)

 

Tocsaineacht ildáileog

OECD Test Guideline 407: Repeated Dose 28-Day Oral Toxicity Study in Rodents (2008)

B.7.

OECD Test Guideline 412: Subacute Inhalation Toxicity: 28-Day Study (2018)

(B.8.)

OECD Test Guideline 410: Repeated Dose Dermal Toxicity: 21/28-Day Study (1981)

B.9.

OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (2016)

B.64.

OECD Test Guideline 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents (2018)

(B.26.)

OECD Test Guideline 409: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents (1998)

B.27.

OECD Test Guideline 413: Subchronic Inhalation Toxicity: 90-Day Study (2018)

(B.29.)

OECD Test Guideline 411: Subchronic Dermal Toxicity: 90-Day Study (1981)

B.28.

OECD Test Guideline 452: Chronic Toxicity Studies (2018)

(B.30.)

OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies (2018)

(B.33.)

Tocsaineacht atáirgthe/Tocsaineacht forbraíochta

OECD Test Guideline 443: Extended One-Generation Reproduction Toxicity Study (2018)

(B.56.)

OECD Test Guideline 421: Reproduction/Developmental Toxicity Screening Test (2016)

B.63.

OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (2016)

B.64.

OECD Test Guideline 414: Prenatal Developmental Toxicity Study (2018)

(B.31.)

Tocsainchinéitic

OECD Test Guideline 417: Toxicokinetics (2010)

B.36.

OECD Test Guideline 428: Skin Absorption: In Vitro Method (2004)

B.45.

OECD Test Guideline 427: Skin Absorption: In Vivo Method (2004)

B.44.

Carcanaigineacht

OECD Test Guideline 451: Carcinogenicity Studies (2018)

(B.32.)

OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies (2018)

(B.33.)

EU test method B.21. In Vitro Mammalian Cell Transformation Test

B.21.

Néaratocsaineacht (forbraíochta)

OECD Test Guideline 424: Neurotoxicity Study in Rodents (1997)

B.43.

OECD Test Guideline 426: Developmental Neurotoxicity Study (2007)

B.53.

OECD Test Guideline 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure (1995)

B.37.

OECD Test Guideline 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study (1995)

B.38.

Airíonna suaite inchrínigh

In vitro

OECD Test Guideline 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonistsals (2021)

(B.66.)

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)

 

OECD Test Guideline 493: Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity (2015)

B.70.

In vivo

OECD Test Guideline 440: Uterotrophic Bioassay in Rodents A short-term screening test for oestrogenic properties (2007)

B.54.

OECD Test Guideline 441: Hershberger Bioassay in Rats, A Short-term Screening Assay for (Anti)Androgenic Properties (2009)

B.55.

Fótatocsaineacht

OECD Test Guideline 432: In Vitro 3T3 NRU Phototoxicity Test (2019)

(B.41.)

OECD Test Guideline 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity (2019)

 

OECD Test Guideline 498: In Vitro Phototoxicity Test Method Using the Reconstructed Human Epidermis (RhE) (2021)

 

TÁBLA 3: MODHANNA TÁSTÁLA LE hAGHAIDH AIRÍONNA ÉICEATHOCSAINEOLAÍOCHA

Críochphointe

Modh tástála

Caibidil chomhfhreagrach i gCuid C den Iarscríbhinn seo, ina bhfuil tuairisc iomlán an mhodha tástála (léirítear leis na huimhreacha atá idir lúibíní gur scriosadh caibidil ó Chuid C ina raibh an tuairisc iomlán ar an modh tástála; cill fholamh: níl modh tástála AE comhfhreagrach i gCuid C den Iarscríbhinn seo)

Tocsaineacht uisceach

OECD Test Guideline 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test (2011)

C.3.

OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation) (2010)

C.11.

OECD Test Guideline 224: Determination of the Inhibition of the Activity of Anaerobic Bacteria (2007)

C.34.

OECD Test Guideline 244: Protozoan Activated Sludge Inhibition Test (2017)

 

OECD Test Guideline 221: Lemna sp. Growth Inhibition Test (2006)

C.26.

OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test (2004)

C.2.

OECD Test Guideline 211: Daphnia magna Reproduction Test (2012)

C.20.

OECD Test Guideline 203: Fish, Acute Toxicity Test (2019)

(C.1.)

OECD Test Guideline 210: Fish, Early-life Stage Toxicity Test (2013)

C.47.

OECD Test Guideline 215: Fish, Juvenile Growth Test (2000)

C.14.

OECD Test Guideline 236: Fish Embryo Acute Toxicity (FET) Test (2013)

C.49.

OECD Test Guideline 249: Fish Cell Line Acute Toxicity - the RTgill-W1 Cell Line Assay (2021)

 

OECD Test Guideline 242: Potamopyrgus antipodarum Reproduction Test (2016)

 

OECD Test Guideline 243: Lymnaea stagnalis Reproduction Test (2016)

 

Díghrádú

OECD Test Guideline 111: Hydrolysis as a Function of pH (2004)

C.7.

OECD Test Guideline 301: Ready Biodegradability (1992)

C.4.

OECD Test Guideline 302A: Inherent Biodegradability: Modified SCAS Test (1981)

C.12.

OECD Test Guideline 302B: Inherent Biodegradability: Zahn-Wellens/EMPA Test (1992)

(C.9).

OECD Test Guideline 302C: Inherent Biodegradability: Modified MITI Test (II) (2009)

 

OECD Test Guideline 303: Simulation Test - Aerobic Sewage Treatment -- A: Activated Sludge Units; B: Biofilms (2001)

C.10.

OECD Test Guideline 304A: Inherent Biodegradability in Soil (1981)

 

OECD Test Guideline 306: Biodegradability in Seawater (1992)

C.42.

OECD Test Guideline 307: Aerobic and Anaerobic Transformation in Soil (2002)

C.23.

OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems (2002)

C.24.

OECD Test Guideline 309: Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test (2004)

C.25.

OECD Test Guideline 310: Ready Biodegradability - CO2 in sealed vessels (Headspace Test) (2014)

C.29.

OECD Test Guideline 311: Anaerobic Biodegradability of Organic Compounds in Digested Sludge: by Measurement of Gas Production (2006)

C.43.

OECD Test Guideline 314: Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater (2008)

 

OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2008)

 

EU test method C.5. Degradation – Biochemical Oxygen Demand

C.5.

EU test method C.6. Degradation – Chemical Oxygen Demand

C.6.

Cinniúint agus iompraíocht sa chomhshaol

OECD Test Guideline 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure (2012)

C.13.

OECD Test Guideline 315: Bioaccumulation in Sediment-Dwelling Benthic Oligochaetes (2008)

C.46.

OECD Test Guideline 317: Bioaccumulation in Terrestrial Oligochaetes (2010)

C.30.

OECD Test Guideline 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media (2017)

 

OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) (2001)

C.19.

OECD Test Guideline 106: Adsorption - Desorption Using a Batch Equilibrium Method (2000)

C.18.

OECD Test Guideline 312: Leaching in Soil Columns (2004)

C.44.

OECD Test Guideline 313: Estimation of Emissions from Preservative - Treated Wood to the Environment (2007)

C.45.

OECD Test Guideline 319A: Determination of In Vitro Intrinsic Clearance Using Cryopreserved Rainbow Trout Hepatocytes (RT-HEP) (2018)

 

OECD Test Guideline 319B: Determination of In Vitro Intrinsic Clearance Using Rainbow Trout Liver S9 Sub-Cellular Fraction (RT-S9) (2018)

 

OECD Test Guideline 320: Anaerobic Transformation of Chemicals in Liquid Manure (2022)

 

Éifeachtaí ar orgánaigh thalún

OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test (2000)

C.21.

OECD Test Guideline 217: Soil Microorganisms: Carbon Transformation Test (2000)

C.22.

OECD Test Guideline 207: Earthworm, Acute Toxicity Tests (1984)

C.8.

OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) (2016)

(C.33.)

OECD Test Guideline 220: Enchytraeid Reproduction Test (2016)

(C.32.)

OECD Test Guideline 226: Predatory Mite (Hypoaspis (Geolaelaps) aculeifer) Reproduction Test in Soil (2016)

(C.36.)

OECD Test Guideline 232: Collembolan Reproduction Test in Soil (2016)

(C.39.)

OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test (2006)

C.31.

OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test (2006)

 

Éifeachtaí ar orgánaigh dhríodair

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.

OECD Test Guideline 233: Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment (2010)

C.40.

OECD Test Guideline 235: Chironomus sp., Acute Immobilisation Test (2011)

 

OECD Test Guideline 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment (2007)

C.35.

OECD Test Guideline 238: Sediment-Free Myriophyllum Spicatum Toxicity Test (2014)

C.50.

OECD Test Guideline 239: Water-Sediment Myriophyllum Spicatum Toxicity Test (2014)

C.51.

Éifeachtaí ar éin

OECD Test Guideline 205: Avian Dietary Toxicity Test (1984)

 

OECD Test Guideline 206: Avian Reproduction Test (1984)

 

OECD Test Guideline 223: Avian Acute Oral Toxicity Test (2016)

 

Éifeachtaí ar fheithidí

OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test (1998)

C.16.

OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test (1998)

C.17.

OECD Test Guideline 237: Honey Bee (Apis Mellifera) Larval Toxicity Test, Single Exposure (2013)

 

OECD Test Guideline 245: Honey Bee (Apis Mellifera L.), Chronic Oral Toxicity Test (10-Day Feeding) (2017)

 

OECD Test Guideline 246: Bumblebee, Acute Contact Toxicity Test (2017)

 

OECD Test Guideline 247: Bumblebee, Acute Oral Toxicity Test (2017)

 

OECD Test Guideline 228: Determination of Developmental Toxicity to Dipteran Dung Flies (Scathophaga stercoraria L. (Scathophagidae), Musca autumnalis De Geer (Muscidae)) (2016)

 

Airíonna suaite inchrínigh

OECD Test Guideline 230: 21-Day Fish Assay (2009)

C.37.

OECD Test Guideline 229: Fish Short Term Reproduction Assay (2012)

C.48.

OECD Test Guideline 231: Amphibian Metamorphosis Assay (2009)

C.38.

OECD Test Guideline 234: Fish Sexual Development Test (2011)

C.41.

OECD Test Guideline 240: Medaka Extended OneGeneration Reproduction Test (MEOGRT) (2015)

C.52.

OECD Test Guideline 241: The Larval Amphibian Growth and Development Assay (LAGDA) (2015)

C.53.”

OECD Test Guideline 248: Xenopus Eleutheroembryonic Thyroid Assay (XETA) (2019)

 

OECD Test Guideline 250: EASZY assay - Detection of Endocrine Active Substances, Acting Through Estrogen Receptors, Using Transgenic tg(cyp19a1b:GFP) Zebrafish embrYos (2021)’

 

OECD Test Guideline 251: Rapid Androgen Disruption Activity Reporter (RADAR) Assay (2022)

 

(2)

i gcuid A, cuirtear an méid seo a leanas in ionad an téacs atá faoi theidil Chaibidlí A.3., A.4., A.8. go A.12., A15. go A.17., A.20. agus A.21.: “Scriosadh an tuairisc iomlán ar an modh tástála seo. An modh tástála idirnáisiúnta coibhéiseach, nó na modhanna tástála eile is infheidhme le haghaidh an chríochphointe atá i gceist, tá siad i dTábla 1 de Chuid 0.”

(3)

i gcuid B, cuirtear an méid seo a leanas in ionad an téacs atá faoi theidil Chaibidlí B.3., B.5., B.6., B.8., B.13/14., B.17., B.26., B.29. go B.33., B.40bis., B.41., B.46. go B.48., B.51., B.56., B.58. go B.61., B.66., B.68., B.69. agus B.71.: “Scriosadh an tuairisc iomlán ar an modh tástála seo. Tá an modh tástála idirnáisiúnta coibhéiseach i dTábla 2 de Chuid 0.”

(4)

i gcuid B, cuirtear an méid seo a leanas in ionad an téacs atá faoi theidil Chaibidlí B.22., B.25., B.34., B.35., B.39.: “Scriosadh an modh tástála seo, mar nach n-aithnítear a thuilleadh é mar mhodh tástála atá iomchuí chun faisnéis a ghiniúint maidir le hairíonna tocsaineolaíocha ceimiceán chun críoch Rialachán (CE) Uimh. 1907/2006. Na modhanna tástála is infheidhme le haghaidh an chríochphointe atá i gceist, tá siad i dTábla 2 de Chuid 0.”

(5)

i gcuid C, cuirtear an méid seo a leanas in ionad an téacs atá faoi theidil Chaibidlí C.1., C.9., C.32., C.33., C.36. agus C.39.: “Scriosadh an tuairisc iomlán ar an modh tástála seo. Tá an modh tástála idirnáisiúnta coibhéiseach i dTábla 3 de Chuid 0.”

(6)

i gcuid C, cuirtear an méid seo a leanas in ionad an téacs atá faoi theidil Chaibidil C.15: “Scriosadh an modh tástála seo, toisc nach n-aithnítear é a thuilleadh mar modh atá iomchuí chun faisnéis a ghiniúint maidir le hairíonna éiceathocsaineolaíocha ceimiceán chun críoch Rialachán (CE) Uimh. 1907/2006. Na modhanna tástála is infheidhme le haghaidh an chríochphointe atá i gceist, tá siad i dTábla 3 de Chuid 0.”