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ANNEX X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70]
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ANNEX X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70]
At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 12(1)(e).
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 1000 tonnes or more in accordance with Article 12(1)(e). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII, VIII and IX. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each adaptation under the appropriate headings in the registration dossier.
In addition to these specific rules, a registrant may propose to adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI [71].
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.
When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.
8. TOXICOLOGICAL INFORMATION
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
| 8.4.If there is a positive result in any of the in vitro genotoxicity studies in Annexes VII or VIII, a second in vivo somatic cell test may be necessary, depending on the quality and relevance of all the available data.If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered. |
| 8.6.3.A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, oreffects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, orthe substance may have a dangerous property that cannot be detected in a 90-day study. |
| 8.6.4.Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:toxicity of particular concern (e.g. serious/severe effects), orindications of an effect for which the available evidence is inadequate for toxicological evaluation and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity), orparticular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity is observed). |
8.7.Reproductive toxicity | 8.7.The studies need not be conducted if:the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, orthe substance is known to be a germ cell mutagen and appropriate risk management measures are implemented, orthe substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for development toxicity must be considered.If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr Cat 1 or 2: R61, and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered. |
8.7.2.Developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure (OECD 414). | |
8.7.3.Two-generation reproductive toxicity study, one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, unless already provided as part of Annex IX requirements | |
8.9.1.Carcinogenicity study | 8.9.1.A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, andthe substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.If the substances is classified as mutagen category 1 or 2, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required. |
9. ECOTOXICOLOGICAL INFORMATION
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
9.2.Degradation | 9.2.Further biotic degradation testing shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil). |
9.2.1.Biotic | |
9.3.Fate and behaviour in the environment
9.3.4.Further information on the environmental fate and behaviour of the substance and/or degradation products | 9.3.4.Further testing shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the chemical safety assessment according to Annex I indicates the need to investigate further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. |
9.4.Effects on terrestrial organisms | 9.4.Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment.These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. |
9.4.4.Long-term toxicity testing on invertebrates, unless already provided as part of Annex IX requirements. | |
9.4.6.Long-term toxicity testing on plants, unless already provided as part of Annex IX requirements. | |
9.5.1.Long-term toxicity to sediment organisms | 9.5.1.Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. |
9.6.1.Long-term or reproductive toxicity to birds | 9.6.1.Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level. |
10. METHODS OF DETECTION AND ANALYSIS
Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.
Referred by:
ARTICLE 10: Information to be submitted for general registration purposes
ARTICLE 12: Information to be submitted depending on tonnage
ARTICLE 13: General requirements for generation of information on intrinsic properties of substances
ARTICLE 22: Further duties of registrants
ARTICLE 40: Examination of testing proposals
ARTICLE 41: Compliance check of registrations
ARTICLE 43: Procedure and time periods for examination of testing proposals
ARTICLE 46: Requests for further information and check of information submitted
ARTICLE 119: Electronic public access
ANNEX I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
ANNEX VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ANNEX XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X