Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20160401 → 02006R1907-20160621

ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are … 1,289 unchanged words … in air. 7.14. Granulometry 7.14. The study does not need to be conducted if the substance is marketed or used in a non solid or granular form. 8. TOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 8.1. Skin irritation or skin corrosion corrosion/irritation 8.1. The assessment of this endpoint shall comprise the following consecutive steps: (1) an assessment of the available human and animal data, (2) an assessment of the acid or alkaline reserve, (3) in vitro study for skin corrosion, (4) in vitro study for skin irritation. 8.1. Steps 3 and 4 do study/ies do(es) not need to be conducted if: the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that the criteria are met for classification it should be classified as corrosive to the skin or irritating to eyes, corrosion (Category 1), or the substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or the substance is classified as very toxic in contact with skin, acute toxicity by the dermal route (Category 1), or an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight). 8.2. Eye irritation The assessment of this endpoint shall comprise the following consecutive steps: (1) an assessment If results from one of the available human and animal data, (2) an assessment two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the acid or alkaline reserve, (3) absence of skin irritation potential, the second study need not be conducted. 8.1.1. Skin corrosion, in vitro study for 8.1.2. Skin irritation, in vitro 8.2. Serious eye irritation. damage/eye irritation 8.2. Step 3 does The study/ies do(es) not need to be conducted if: the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1), or the substance is classified as skin irritation and the available information indicates that the criteria are met for classification it should be classified as corrosive to the skin or irritating to eyes, eye irritation (Category 2), or the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as serious eye damage (Category 1), or the substance is spontaneously flammable in air or in contact with water or moisture at room temperature; temperature. 8.2.1. Serious eye damage/eye irritation, in vitro 8.2.1. If results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/ies) for this endpoint shall be considered. 8.3. Skin sensitisation The assessment of this endpoint shall comprise the following consecutive steps: (1) an assessment of the available human, animal and alternative data, (2) In vivo testing. 8.3. Step 2 does not need to be conducted if: the available information indicates that the substance should be classified for skin sensitisation or corrosivity, or the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or the substance is flammable in air at room temperature. The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another test shall be provided. 8.4. Mutagenicity 8.4. Further mutagenicity studies shall be considered in case of a positive result. 8.4.1. In vitro gene mutation study in bacteria 8.5. Acute toxicity 8.5. The study/ies do(es) not generally need to be conducted if: the substance is classified as corrosive to the skin. 8.5.1. By oral route The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available. 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.1. Aquatic toxicity 9.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia) The registrant may consider long-term toxicity testing instead of short-term. 9.1.1. The study does not need to be conducted if: there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or a long-term aquatic toxicity study on invertebrates is available, or adequate information for environmental classification and labelling is available. The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if the substance is poorly water soluble. 9.1.2. Growth inhibition study aquatic plants (algae preferred) 9.1.2. The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes. 9.2. Degradation 9.2.1. Biotic 9.2.1.1. Ready biodegradability 9.2.1.1. The study does not need to be conducted if the substance is inorganic. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.

02006R1907-20160401 → 02006R1907-20160621

ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are … 324 unchanged words … 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 8.1. Skin irritation 8.1.1. In corrosion/irritation 8.1. An in vivo study for skin irritation 8.1.1. corrosion/irritation shall be considered only if the in vitro studies under points 8.1.1 and 8.1.2 in Annex VII are not applicable, or the results of these studies are not adequate for classification and risk assessment. The study does not need to be conducted if: the substance is classified as corrosive to the skin or as a skin irritant, or the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or the substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or the substance is classified as very toxic in contact with skin, acute toxicity by the dermal route (Category 1), or an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight). 8.2. Eye Serious eye damage/eye irritation 8.2.1. In 8.2. An in vivo study for eye irritation 8.2.1. corrosion/irritation shall be considered only if the in vitro study(ies) under point 8.2.1 in Annex VII are not applicable, or the results obtained from these study(ies) are not adequate for classification and risk assessment. The study does not need to be conducted if: the substance is classified as irritating to eyes with risk of serious damage to eyes, or the substance is classified as corrosive to the skin and provided that the registrant classified the substance as eye irritant, corrosion, or the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or the substance is spontaneously flammable in air or in contact with water or moisture at room temperature. 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 if adequate data from an in vivo cytogenicity test are available, or the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2. 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: the substance is classified as corrosive to the skin. skin corrosion. In addition to the oral route (8.5.1), (Annex VII, 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 needs to 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. Testing by the dermal route does not need to be conducted if: the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies). 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 … 1,069 unchanged words … need to 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), or the substance and its relevant degradation products decompose rapidly.