[X1ANNEX VIII U.K. STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE (1)
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 10 tonnes or more in accordance with Article 12(1)(c). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annex VII. 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 required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.
In addition to these specific rules, a registrant may 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 adapt 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 (2) .
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, information is not provided 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 U.K.
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
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8.1. Skin irritation | |
8.1.1. In vivo skin irritation | 8.1.1. The study does not need to be conducted if:
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8.2. Eye irritation | |
8.2.1. In vivo eye irritation | 8.2.1. The study does not need to be conducted if:
|
8.4. Mutagenicity | |
8.4.2. In vitro cytogenicity study in mammalian cells or in vitro micronucleus study | 8.4.2. The study does not usually need to be conducted
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8.4.3. In vitro gene mutation study in mammalian cells, if a negative result in Annex VII, Section 8.4.1. and Annex VIII, Section 8.4.2. | 8.4.3. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available. |
8.4. Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII. | |
8.5. Acute toxicity | 8.5. The study/ies do(es) not generally need to be conducted if:
In addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. |
8.5.2. By inhalation | 8.5.2. 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. |
8.5.3. By dermal route | 8.5.3. Testing by the dermal route is appropriate if:(1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. |
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. | 8.6.1. The short-term toxicity study (28 days) does not need to be conducted if:
The appropriate route shall be chosen on the following basis: Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. 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. The sub-chronic toxicity study (90 days) (Annex IX, Section 8.6.2) shall be proposed by the registrant if: the frequency and duration of human exposure indicates that a longer term study is appropriate; and one of the following conditions is met:
Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case of:
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8.7. Reproductive toxicity | |
8.7.1. Screening for reproductive/developmental toxicity, one species (OECD 421 or 422), if there is no evidence from available information on structurally related substances, from (Q)SAR estimates or from in vitro methods that the substance may be a developmental toxicant | 8.7.1. This study does not need to be conducted if:
[F1If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), 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.] In cases where there are serious concerns about the potential for adverse effects on fertility or development, either a pre-natal developmental toxicity study (Annex IX, Section 8.7.2) or a two-generation reproductive toxicity study (Annex IX, Section 8.7.3) may be proposed by the registrant instead of the screening study. |
8.8. Toxicokinetics | |
8.8.1. Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information |
9. ECOTOXICOLOGICAL INFORMATION U.K.
[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]
[X1Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.]
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).