Atsauce uz Regulas (ES) Nr. 283/2013 pielikuma A daļu Testēšanas metodes (2) Vadlīnijas (3)

1. DARBĪGĀS VIELAS IDENTITĀTE — WHO/FAO. 2002. Pesticide Specifications. Manual on development and use of FAO and WHO specifications for pesticides. Series FAO Plant Production and Protection Papers, Rome, 2002 (4) EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No. 1107/2009 (5) (SANCO/10597/2003 rev. 10.1)

2. DARBĪGĀS VIELAS FIZIKĀLĀS UN ĶĪMISKĀS ĪPAŠĪBAS —

2.1. Kušanas punkts un viršanas punkts Method A.1 Melting/Freezing temperature (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 102: Melting Point/ Melting Range Method A.2 Boiling temperature (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 103: Boiling point —

2.2. Tvaika spiediens, gaistamība Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Izskats (fizikālais stāvoklis, krāsa) — —

2.4. Spektri (UV/VIS, IR, NMR, MS), molārā ekstinkcija pie attiecīgiem viļņu garumiem, optiskā tīrība OECD Test Guideline 101: UV-VIS Absorption Spectra —

2.5. Šķīdība ūdenī Method A.6 Water solubility (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 105: Water Solubility —

2.6. Šķīdība organiskajos šķīdinātājos CIPAC Method MT 181: Solubility in organic solvents —

2.7. N-oktanola/ūdens sadalījuma koeficients Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Ja savienojums ir virsmaktīvs (kā definēts A.5. metodē “Virsmas spraigums”), var izmantot A.8. metodē aprakstīto “kolbu kratīšanas metodi”, ja ziņojumā ir skaidri norādīts, ka problēmas nav radušās (piem., fāzu atdalīšana). A.8. metodē aprakstītā augstas izšķirtspējas šķidruma hromatogrāfijas (HPLC) metode virsmaktīviem savienojumiem nav izmantojama. —

2.8. Disociācija ūdenī OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Uzliesmojamība un pašsakarstamība Uzliesmojamība Methods A.10 Flammability (solids), A.11 Flammability (gases), A.12 Flammability (contact with water) (Annex to Regulation (EC) No 440/2008), as appropriate; Test N.1: test method for readily combustible solids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 33.2.1.4) Pašsakarstamība Methods A.15 Auto-ignition temperature (liquids and gases), A16 Relative self-ignition temperature for solids, (Annex to Regulation (EC) No 440/2008), as appropriate. Test N.4: test method for self-heating substances (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 33.3.1.6) —

2.10. Uzliesmošanas punkts Method A.9 Flash-point (Annex to Regulation (EC) No 440/2008) - only closed cup methods should be used. Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008 (6) (liquids); —

2.11. Sprādzienbīstamība Method A.14 Explosive properties (Annex to Regulation (EC) No 440/2008) United Nations Recommendations on the Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/ Rev. 5 – Part I (Test series), section 11. —

2.12. Virsmas spraigums Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Oksidējamība Cietas vielas: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Šķidrumi: Method A.21 Oxidising properties (liquids) (Annex to Regulation (EC) No 440/2008) United Nations Recommendations on the Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 4 – Part I (Test series). Test O.1: Test for oxidizing solids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 34.4.1) Test O.2: Test for oxidizing liquids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 34.4.2) —

2.14. Citi pētījumi Regulas (EK) Nr. 1272/2008 I pielikuma II daļā izklāstītās pārbaudes metodes —

3. SĪKĀKA INFORMĀCIJA PAR DARBĪGO VIELU EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. Darbīgās vielas izmantojums — —

3.2. Funkcija — —

3.3. Iedarbība uz kaitīgajiem organismiem — —

3.4. Paredzētā lietošanas joma — —

3.5. Apkarotie kaitīgie organismi un aizsargātie vai apstrādātie kultūraugi vai produkti — —

3.6. Iedarbības veids — —

3.7. Informācija par rezistences veidošanos vai iespējamu veidošanos un attiecīgām pārvaldības stratēģijām EPPO standard PP 1/213: Resistance risk analysis —

3.8. Metodes un piesardzības pasākumi attiecībā uz manipulēšanu, uzglabāšanu, transportēšanu un ugunsdrošību — —

3.9. Iznīcināšanas un dekontaminācijas procedūras — —

3.10. Ārkārtas pasākumi avārijas gadījumā — —

4. ANALĪZES METODES — Tehniskais materiāls un preparāti EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Atliekas EU guidance document on analytical methods for the determination of residues (Post-registration monitoring and control) (SANCO/825/00 rev. 8.1, 2010) EU guidance document for generating and reporting methods of analysis in support of pre-registration data requirements (SANCO/3029/99 rev. 4). OECD (2007). Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment No. 72 and Series on Pesticides No. 39.

5. TOKSIKOLOĢIJAS UN METABOLIZĒŠANĀS PĒTĪJUMI — —

5.1. Absorbēšanās, izplatīšanās pa organismu, metabolizēšanās un ekskrēcijas pētījumi ar zīdītājiem — EU Working Document. Draft Guidance for the Setting and Application of Acceptable Operator Exposure Levels (AOEL’s) (SANCO 7531 rev. 10, 10.07.2006) OECD (2010) Guidance for the Derivation of an Acute Reference Dose” OECD Series on testing and assessment, No. 124, 08-Jun-2010

5.1.1. Absorbēšanās, izplatīšanās pa organismu, metabolizēšanās un ekskrēcija pēc orālās ekspozīcijas Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. Absorbēšanās, izplatīšanās pa organismu, metabolizēšanās un ekskrēcija pēc ekspozīcijas pa citiem ceļiem Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Akūtais toksiskums — —

5.2.1. Orālais toksiskums Method B.1 bis Acute oral toxicity - fixed dose procedure (Annex to Regulation (EC) No 440/2008). Method B.1 tris Acute oral toxicity - Acute toxic class method (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure OECD Test Guideline 423: Acute oral toxicity: acute toxic class method OECD Test Guideline 425: Acute oral toxicity: up-and-down procedure OECD Test Guideline No 401: Acute oral toxicity (only acceptable, if performed before December 2002) —

5.2.2. Dermālais toksiskums Method B.3 Acute toxicity (dermal) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 402: Acute Dermal Toxicity —

5.2.3. Inhalatīvais toksiskums Method B.2 Acute toxicity (inhalation) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 403: Acute Inhalation Toxicity OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method —

5.2.4. Ādas kairinājums Method B.4 Acute toxicity: dermal irritation/corrosion (Annex to Regulation (EC) No 440/2008). Method B.40 In vitro skin corrosion: transcutaneous electrical resistance test (TER) (Annex to Regulation (EC) No 440/2008). Method B.40 bis In vitro skin corrosion: human skin model test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 404: Acute Dermal Irritation/Corrosion OECD Test Guideline 431: In vitro Skin Corrosion: Human Skin Model Test OECD Test Guideline 430: In vitro Skin Corrosion: Transcutaneous Electrical Resistance Test OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method Method B.46 In vitro skin irritation: reconstructed human epidermis model test (Annex III of Regulation (EC) No 761/2009 (8)). —

5.2.5. Acu kairinājums Method B.5 Acute toxicity: eye irritation/corrosion (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 405: Acute eye irritation/corrosion OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants Method B.47 Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants (Annex of Regulation (EC) No 1152/2010 (9)) Method B.48 Isolated chicken eye test method for identifying ocular corrosives and severe irritants (Annex of Regulation (EC) No 1152/2010) —

5.2.6. Ādas sensibilizācija Method B.42 Skin sensitisation: Local lymph node assay (Annex to Regulation (EC) No 440/2008). Method B.6 Skin sensitisation (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay OECD Test Guideline 406: Skin sensitisation OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA —

5.2.7. Fototoksiskums Method B.41 In vitro 3T3 NRU phototoxicity test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 432: In vitro 3T3 NRU Phototoxicity Test OECD Test Guideline 101: UV-VIS Absorption Spectra —

5.3. Īslaicīgais toksiskums — —

5.3.1. 28 dienu orālās iedarbības pētījums Method B.7 Repeated dose (28 days) toxicity (oral) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 407: Repeated dose 28-day oral toxicity study in rodents —

5.3.2. 90 dienu orālās iedarbības pētījums Method B.26 Sub-chronic oral toxicity test. Repeated dose 90-day oral toxicity study in rodents (Annex to Regulation (EC) No 440/2008). Method B.27 Sub-chronic oral toxicity test. Repeated dose 90-day oral toxicity study in non-rodents (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 408: Repeated dose 90-day oral toxicity study in rodents OECD Test Guideline 409: Repeated dose 90-day oral toxicity study in non-rodents —

5.3.3. Citi iedarbības ceļi Method B8 Repeated dose (28 days) toxicity (inhalation) (Annex to Regulation (EC) No 440/2008). Method B.9 Repeated dose (28 days) toxicity (dermal) (Annex to Regulation (EC) No 440/2008). Method B.28 Sub-chronic dermal toxicity test: 90-day repeated dermal dose study using rodent species (Annex to Regulation (EC) No 440/2008). Method B.29 Sub-chronic inhalation toxicity study 90-day repeated inhalation dose study using rodent species (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 410: Repeated dose dermal toxicity: 21/28-day study. OECD Test Guideline 411: Subchronic dermal toxicity: 90-day study. OECD Test Guideline 412: Subacute inhalation toxicity: 28-day study. OECD Test Guideline 413: Subchronic inhalation toxicity: 90-day study. —

5.4. Genotoksiskuma testēšana — —

5.4.1. In vitro pētījumi Method B.13/14 Mutagenicity - reverse mutation test using bacteria (Annex to Regulation (EC) No 440/2008). Method B.10 Mutagenicity - In vitro mammalian chromosome aberration test (Annex to Regulation (EC) No 440/2008). Method B.17 – Mutagenicity – In vitro mammalian cell gene mutation test (Annex to Regulation (EC) No 440/2008). - For this test mouse lymphoma assay is recommended. OECD Test Guideline 471: Bacterial Reverse Mutation Test OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test OECD Test Guideline 476: In vitro Mammalian Cell Gene Mutation Test - For this test mouse lymphoma assay is recommended. OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test. In vitro Comet assay could be used when justified. —

5.4.2. In vivo pētījumi somatiskajās šūnās Method B.12 - Mutagenicity - In vivo mammalian erythrocyte micronucleus test (Annex to Regulation (EC) No 440/2008). Method B.11 - Mutagenicity – In vivo mammalian bone-marrow chromosome aberration test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test OECD Test Guideline 486: Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo. OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays Method B.39 Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo (Annex to Regulation (EC) No 440/2008). In vivo Comet assay could be used when justified and considering EFSA (2012). Minimum Criteria for the acceptance of in vivo alkaline Comet Assay Reports. EFSA Journal 2012;10(11):2977

5.4.3. In vivo pētījumi dzimumšūnās Method B.23 Mammalian spermatogonial chromosome aberration test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test. OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays. —

5.5. Ilglaicīgs toksiskums un kancerogenitāte Method B.30 Chronic toxicity test (Annex to Regulation (EC) No 440/2008). Method B.32 Carcinogenicity test (Annex to Regulation (EC) No 440/2008). Method B.33 Combined chronic toxicity/carcinogenicity test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 451: Carcinogenicity Studies. OECD Test Guideline 452: Chronic Toxicity Studies. OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies. —

5.6. Reprotoksiskums —

5.6.1. Paaudžu pētījumi Method B.35 Two-generation reproduction toxicity study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 416: Two-Generation Reproduction Toxicity. OECD Test Guideline 443: Extended One-generation Reproduction Toxicity. —

5.6.2. Pētījumi par toksiskuma ietekmi attīstības stadijās Method B.31 Prenatal developmental toxicity study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 414: Prenatal developmental toxicity study. OECD Test Guideline 426: Developmental neurotoxicity study. —

5.7. Neirotoksiskuma pētījumi —

5.7.1. Neirotoksiskuma pētījumi ar grauzējiem Method B.43 Neurotoxicity study in rodents (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 424: Neurotoxicity study in rodents. —

5.7.2. Novēlotas polineiropātijas pētījumi Method B.37 Delayed neurotoxicity of organophosphorus substances after acute exposure (Annex to Regulation (EC) No 440/2008). Method B.38 Delayed neurotoxicity of organophosphorus substances 28-day repeated dose study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure. OECD Test Guideline 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study. —

5.8. Citi toksiskuma pētījumi — —

5.8.1. Metabolītu toksiskuma pētījumi EU Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council Directive 91/414/EEC (SANCO/221/2000 – rev.10. final)

5.8.2. Papildu pētījumi par darbīgo vielu — OECD (2010) Guidance for conducting a single exposure toxicity study. IN: OECD (2010) Guidance for the Derivation of an Acute Reference Dose” OECD Series on testing and assessment, No. 124, 08-Jun-2010

5.8.3. Īpašības, kas izraisa endokrīnās sistēmas darbības traucējumus OECD Test Guideline 456: H295R Steroidogenesis Assay OECD Test Guideline 441: Hershberger Bioassay in Rats, A Short-term Screening Assay for (Anti)Androgenic Properties OECD Test Guideline 455: Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals OECD Test Guideline 440: Uterotrophic Bioassay in Rodents A short-term screening test for oestrogenic properties OCSPP Guideline 890.1500: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Male Rats Assay OCSPP Guideline 890.1450: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Female Rats Assay U.S. Environmental Protection Agency (2007): 15-Day Intact Adult Male Rat Assay —

5.9. Medicīniskie dati — —

6. ATLIEKAS APSTRĀDĀTOS PRODUKTOS, PĀRTIKĀ UN BARĪBĀ VAI UZ TIEM OECD (2009). Guidance Document on Overview of Residue Chemistry Studies (as revised in 2009). Environment, Health and Safety Publications. Series on Testing and Assessment No. 64 and Series on Pesticides No. 32.

6.1. Atlieku stabilitāte uzglabāšanā OECD Test Guideline 304A: Stability of pesticide residues in stored commodities —

6.2. Atlieku metabolizēšanās, izplatīšanās organismā un izteikšana — —

6.2.1. Augi OECD Test Guideline 501: Metabolism in crops —

6.2.2. Mājputni OECD Test Guideline 503: Metabolism in livestock —

6.2.3. Atgremotāji laktācijas periodā OECD Test Guideline 503: Metabolism in livestock —

6.2.4. Cūkas OECD Test Guideline 503: Metabolism in livestock —

6.2.5. Zivis — —

6.3. Atlieku daudzuma noteikšanas izmēģinājumi ar augiem OECD Test Guideline 509: Crop field trials OECD (2011) Guidance Document on Crop Field Trials (Series on Testing and Assessment No. 164 and Series on Pesticides No. 66)

6.4. Barošanās pētījumi — —

6.4.1. Mājputni OECD Test Guideline 505: Residues in livestock. —

6.4.2. Atgremotāji OECD Test Guideline 505: Residues in livestock. —

6.4.3. Cūkas OECD Test Guideline 505: Residues in livestock. —

6.4.4. Zivis — —

6.5. Apstrādes ietekme — —

6.5.1. Atlieku īpašības OECD Test Guideline 507: Nature of the pesticide residues in processed commodities – High temperature hydrolysis. —

6.5.2. Atlieku sadalījums neēdamā mizā un augļu mīkstumā OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Atlieku daudzums apstrādātās precēs OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD (2008). Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment No. 96.

6.6. Atliekas augu sekas kultūrās — —

6.6.1. Metabolizēšanās augu sekas kultūrās OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Atlieku daudzums augu sekas kultūrās OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Piedāvātās atlieku definīcijas un maksimālie atlieku līmeņi — —

6.7.1. Piedāvātās atlieku definīcijas — OECD (2009). Guidance Document on the Definition of Residues. Environment, Health and Safety Publications. Series on Testing and Assessment No. 63 and Series on Pesticides No. 31

6.7.2. Piedāvātie maksimālie atlieku līmeņi (MAL) un to pieļaujamības pamatojums — EU guidance document "Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs" (SANCO 7525/VI/95 rev. 9, March 2011). OECD MRL calculator (2011)

6.7.3. Piedāvātie maksimālie atlieku līmeņi (MAL) un to pieļaujamības pamatojums importētiem produktiem (importa pielaide) — EU guidance document "Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs" (SANCO 7525/VI/95 rev. 9, March 2011). OECD MRL calculator (2011)

6.8. Piedāvātie drošuma intervāli — EU guidance document "Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals" (SANCO 7039/VI/95, 22/7/1997)

6.9. Skaitliskais novērtējums par iespējamo un faktisko ekspozīciju ar uztura un citu avotu starpniecību — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Citi pētījumi — —

6.10.1. Atlieku līmenis ziedputekšņos un bišu produktos — —

7. APRITE UN UZVEDĪBA VIDĒ — —

7.1. Aprite un uzvedība augsnē OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. ISO 10381-6:2009 Soil quality. Sampling. Guidance on the collection, handling and storage of soil under aerobic conditions for the assessment of microbiological processes, biomass and diversity in the laboratory —

7.1.1. Noārdīšanās ceļš augsnē — —

7.1.1.1. Aerobā noārdīšanās OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Anaerobā noārdīšanās OECD Test Guideline 304A: Aerobic and anaerobic transformation in soil. —

7.1.1.3. Augsnes fotolīze — SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

7.1.2. Noārdīšanās ātrums augsnē — EFSA (2010). EFSA Panel on Plant Protection Products; Guidance for evaluating laboratory and field dissipation studies to obtain DegT50 values of plant protection products in soil. EFSA Journal 2010;8(12):1936.

7.1.2.1. Laboratoriskie pētījumi OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water FOCUS Degradation Kinetics EFSA (2007). Scientific Opinion on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil. The EFSA Journal (2007) 622, 1-32.

7.1.2.2. Lauka pētījumi US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Noārdīšanās ātruma augsnē noteikšanas lauka pētījumos: tehniskie aspekti Regulatory Directive DIR2006-01: Harmonization of Guidance for Terrestrial Field Studies of Pesticide Dissipation under the North American Free Trade Agreement. Pest Management Regulatory Agency (PMRA). Health Canada (11)

7.1.3. Adsorbcija un desorbcija augsnē — —

7.1.3.1. Adsorbcija un desorbcija OECD Test Guideline 106: Adsorption - Desorption Using a Batch Equilibrium Method OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water European Commission. Scientific Committee on plants SCP/KOC/002-Final. Opinion of the Scientific Committee on Plants on methods for the determination of the organic carbon adsorption coefficient (K0c) for a plant protection product active substance in the context of Council Directive 91/414/EEC (18 July 2002) (12)

7.1.3.2. Dinamiskā sorbcija — FOCUS Ground Water

7.1.4. Mobilitāte augsnē — —

7.1.4.1. Kolonnas pētījumi par izskalošanos OECD Test Guideline 312: Leaching in Soil Columns —

7.1.4.2. Lizimetriskie pētījumi OECD Guidance Document 22: Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies FOCUS Ground Water

7.1.4.3. Lauka pētījumi par izskalošanos — FOCUS Ground Water

7.2. Aprite un uzvedība ūdenī un nogulās — —

7.2.1. Noārdīšanās ceļš un ātrums ūdens sistēmās (ķīmiskā un fotoķīmiskā noārdīšanās) — —

7.2.1.1. Hidrolītiskā noārdīšanās OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Tiešā fotoķīmiskā noārdīšanās OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Netiešā fotoķīmiskā noārdīšanās — —

7.2.2. Bionoārdīšanās ceļš un ātrums ūdens sistēmās — —

7.2.2.1. “Tūlītēja bionoārdāmība” Method C.4 Determination of "ready" biodegradability (Annex to Regulation (EC) No 440/2008). OECD Guideline Test 301: Ready Biodegradability (301 A - F) —

7.2.2.2. Aerobā mineralizēšanās virszemes ūdeņos OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test ECHA Guidance on information requirements and chemical safety assessment Chapter R 11: PBT Assessment

7.2.2.3. Ūdens/nogulu pētījums OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Pētījums ar ūdens/nogulu apgaismošanu OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Noārdīšanās piesātinājuma zonā — —

7.3. Aprite un uzvedība gaisā FOCUS Air

7.3.1. Noārdīšanās ceļš un ātrums gaisā — —

7.3.2. Pārnese pa gaisu — —

7.3.3. Lokālā un globālā iedarbība — —

7.4. Atlieku definīcija — —

7.4.1. Atlieku definīcija riska novērtēšanai — —

7.4.2. Atlieku definīcija monitoringam — —

7.5. Monitoringa dati — —

8. EKOTOKSIKOLOĢISKIE PĒTĪJUMI — OECD series of testing and assessment Number 54. "Current approaches in the statistical analysis of ecotoxicity data: a guidance to application"

8.1. Ietekme uz putniem un citiem sauszemes mugurkaulniekiem — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Ietekme uz putniem — —

8.1.1.1. Akūtais orālais toksiskums putniem OECD Test Guideline No 223: Avian acute oral toxicity study vai US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Īslaicīgais uztura toksiskums putniem OECD Test Guideline 205: Avian Dietary Toxicity Test vai US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Subhroniskais toksiskums un reprotoksiskums putniem OECD Test Guideline 206: Avian Reproduction Test vai US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Ietekme uz sauszemes mugurkaulniekiem, kas nav putni — —

8.1.2.1. Akūtais orālais toksiskums zīdītājiem — —

8.1.2.2. Ilglaicīgais toksiskums un reprotoksiskums zīdītājiem — —

8.1.3. Darbīgās vielas biokoncentrācija putnu vai zīdītāju medījumā — —

8.1.4. Ietekme uz savvaļas sauszemes mugurkaulniekiem (putniem, zīdītājiem, rāpuļiem un abiniekiem) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Īpašības, kas izraisa endokrīnās sistēmas darbības traucējumus — Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters. Series on testing and assessment No 118. 18 January 2010.

8.2. Ietekme uz ūdens organismiem — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4) OECD (2000). Guidance document on aquatic toxicity testing of difficult substances and mixtures. OECD series on testing and assessment Number 23.

8.2.1. Akūtais toksiskums zivīm OECD Test Guideline 203: Fish, Acute Toxicity Test (13) OECD. Series on testing and assessment No 126. Short guidance on the threshold approach for acute fish toxicity. ENV/JM/MONO(2010)17

8.2.2. Ilglaicīgais un hroniskais toksiskums zivīm — —

8.2.2.1. Zivju agrīno attīstības stadiju toksiskuma tests OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Zivju pilna dzīves cikla tests US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Biokoncentrācija zivīs — —

8.2.3. Īpašības, kas izraisa endokrīnās sistēmas darbības traucējumus OECD Test Guideline 229: Fish Short Term Reproduction Assay OECD Test Guideline 230: 21-day Fish Assay: A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition OECD Test Guideline 231: Amphibian Metamorphosis Assay OECD Test Guideline 234 Fish Sexual Development Test Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters. Series on testing and assessment No 118. 18 January 2010.

8.2.4. Akūtais toksiskums ūdens bezmugurkaulniekiem — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Akūtais toksiskums Daphnia magna sugas bezmugurkaulniekiem OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Akūtais toksiskums vēl citai ūdens bezmugurkaulnieku sugai US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Ilglaicīgais un hroniskais toksiskums ūdens bezmugurkaulniekiem — —

8.2.5.1. Reprotoksiskums un toksiskums attīstības stadijās Daphnia magna sugas bezmugurkaulniekiem OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Reprotoksiskums un toksiskums attīstības stadijā vēl citai ūdens bezmugurkaulnieku sugai US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. Chironomus riparius sugu īpatņu attīstība un izšķilšanās OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [Augu aizsardzības līdzekļiem raksturīgos ekspozīcijas ceļus parasti labāk aptver sistēma, kurā ar darbīgo vielu ir bagātināts ūdens slānis (t. i., ESAO 219)] —

8.2.5.4. Nogulās mītošie organismi OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Ietekme uz aļģu augšanu — —

8.2.6.1. Ietekme uz zaļaļģu augšanu OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Ietekme uz vēl citas aļģu sugas augšanu OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Ietekme uz ūdens makrofītiem OECD Test Guideline 221: Lemna sp. Growth Inhibition Test ASTM E1913-04: Standard Guide for Conducting Static, Axenic, 14-Day Phytotoxicity Tests in Test Tubes with the Submersed Aquatic Macrophyte, Myriophyllum sibiricum Komarov Development of a proposed test method for the rooted aquatic macrophyte Myriophyllum sp. In: Maltby L, Arnold D, Arts G, et al (2010). Aquatic Macrophyte Risk Assessment for pesticides (AMRAP). SETAC Press & CRC Press, Taylor & -Francis Group, Boca Raton, London, New York, p. 46-56.

8.2.8. Papildu testēšana ar ūdens organismiem — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Ietekme uz posmkājiem — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.3.1. Ietekme uz bitēm — EPPO Standard PP 3/10 (3) Environmental risk assessment scheme for plant protection products. Chapter 10: honeybees.

8.3.1.1. Akūtais toksiskums bitēm —

8.3.1.1.1. Akūtais orālais toksiskums EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees. OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test

8.3.1.1.2. Akūtais kontakttoksiskums EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees. OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test

8.3.1.2. Hroniskais toksiskums bitēm Aupinel et al (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90 Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616.

8.3.1.3. Ietekme uz medus bišu attīstību un citiem medus bišu dzīves posmiem Aupinel et al (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90

8.3.1.4. Subletāla iedarbība Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616.

8.3.2. Ietekme uz nemērķa sugu posmkājiem, kas nav bites Candolfi et al (2001). Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing). SETAC press, pp 46. ISBN 1-880611-52-x.

8.3.2.1. Ietekme uz Aphidius rhopalosiphi sugas posmkājiem M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067-129-7.

8.3.2.2. Ietekme uz Typhlodromus pyri sugas posmkājiem M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067-129-7

8.4. Ietekme uz augsnes mezofaunas un makrofaunas nemērķa sugām — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Subletāla iedarbība uz sliekām OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Ietekme uz augsnes mezofaunas un makrofaunas nemērķa sugām (kas nav sliekas) —

8.4.2.1. Sugu līmeņa testēšana Kolembolas OECD Test Guideline 232: Collembolan Reproduction Test in Soil Plēsīgās ērces OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Ietekme uz augsnes slāpekļa transformāciju OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Ietekme uz sauszemes nemērķa augstāko augu sugām — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Skrīninga datu kopsavilkums — —

8.6.2. Testēšana ar nemērķa sugu augiem Sējeņu izdzīšanās un sējeņu augšana OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Sauszemes augu augtspējas testi OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Ietekme uz citiem sauszemes organismiem (floru un faunu) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Ietekme uz bioloģiskajām notekūdeņu attīrīšanas metodēm OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. LITERATŪRAS DATI EFSA (2011). Guidance of EFSA - Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011; 9(2):209