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ANNEX IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68]
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ANNEX IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68]
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)(d).
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 100 tonnes or more in accordance with Article 12(1)(d). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII and VIII. 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 [69].
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.
7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
7.15.Stability in organic solvents and identity of relevant degradation productsOnly required if stability of the substance is considered to be critical. | 7.15.The study does not need to be conducted if the substance is inorganic. |
7.16.Dissociation constant | 7.16.The study does not need to be conducted if:the substance is hydrolytically unstable (half-life less than 12 hours) or is readily oxidisable in water, orit is scientifically not possible to perform the test for instance if the analytical method is not sensitive enough. |
7.17.Viscosity | |
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 Annex VII or VIII and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed by the registrant.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.Repeated dose toxicity
8.6.1.Short-term repeated dose toxicity study (28 days), 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 VIII requirements or if tests according to Section 8.6.2 of this Annex is proposed. In this case, Section 3 of Annex XI shall not apply. | |
8.6.2.Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure. | 8.6.2.The sub-chronic toxicity study (90 days) does not need to be conducted if:a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure, ora reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, ora substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake), orthe substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day "limit test", particularly if such a pattern is coupled with limited human exposure.The appropriate route shall be chosen on the following basis:Testing by the dermal route is appropriate if:(1)skin contact in production and/or use is likely; and(2)the physicochemical properties suggest a significant rate of absorption through the skin; and(3)one of the following conditions is met:toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test, orsystemic effects or other evidence of absorption is observed in skin and/or eye irritation studies, orin vitro tests indicate significant dermal absorption, orsignificant dermal toxicity or dermal penetration is recognised for structurally-related substances.Testing by the inhalation route is appropriate if:exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.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:failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, ortoxicity of particular concern (e.g. serious/severe effects), orindications of an effect for which the available evidence is inadequate for toxicological 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 to humans may be expected). |
8.7.Reproductive toxicity | 8.7.The studies do not need to 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.Pre-natal developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure (B.31 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 414). | 8.7.2.The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data. |
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, if the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues. | 8.7.3.The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available date. |
9. ECOTOXICOLOGICAL INFORMATION
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
9.1.Aquatic toxicity | 9.1.Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. |
9.1.5.Long-term toxicity testing on invertebrates (preferred species Daphnia), (unless already provided as part of Annex VII requirements) | |
9.1.6.Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements)The information shall be provided for one of the Sections 9.1.6.1, 9.1.6.2 or 9.1.6.3. | |
9.1.6.2.Fish early-life stage (FELS) toxicity test | |
9.1.6.2.Fish short-term toxicity test on embryo and sac-fry stages | |
9.1.6.3.Fish, juvenile growth test | |
9.2.Degradation | 9.2.Further biotic degradation testing shall be proposed by the registrant 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 | |
9.2.1.2.Simulation testing on ultimate degradation in surface water | 9.2.1.2.The study need not be conducted if:the substances is highly insoluble in water, orthe substance is readily biodegradable. |
9.2.1.3.Soil simulation testing (for substances with a high potential for adsorption to soil) | 9.2.1.3.The study need not be conducted:if the substance is readily biodegradable, orif direct and indirect exposure of soil is unlikely. |
9.2.1.4.Sediment simulation testing (for substances with a high potential for adsorption to sediment) | 9.2.1.4.The study need not be conducted:if the substance is readily biodegradable, orif direct and indirect exposure of sediment is unlikely. |
9.2.3.Identification of degradation products | 9.2.3.Unless the substance is readily biodegradable |
9.3.Fate and behaviour in the environment
9.3.2.Bioaccumulation in aquatic species, preferably fish | 9.3.2.The study need not be conducted if:the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes, ordirect and indirect exposure of the aquatic compartment is unlikely. |
9.3.3.Further information on adsorption/desorption depending on the results of the study required in Annex VIII | 9.3.3.The study need not be conducted if:based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), orthe substance and its degradation products decompose rapidly. |
9.4.Effects on terrestrial organisms | 9.4.These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. The choice of the appropriate tests depends on the outcome of the chemical safety assessment.In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term. |
9.4.1.Short-term toxicity to invertebrates | |
9.4.2.Effects on soil micro-organisms | |
9.4.3.Short-term toxicity to plants | |
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 43: Procedure and time periods for examination of testing proposals
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 VII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE [64]
ANNEX VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE [66]
ANNEX X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70]
ANNEX XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X