20

SECTION 2: Hazards identification

21  SECTION 5: Fire fighting measures 22  SECTION 6: Accidental release measures 23  SECTION 7: Handling and storage 24

TOXICOLOGICAL INFORMATION

i.e. extreme pH/corrosive properties) 25

ECOLOGICAL INFORMATION

i.e. log Kow / bioaccumulation) 26  SECTION 13: Disposal considerations 27  SECTION 14: Transport information 28 29 30 31 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 79 1 3.10 SDS SECTION 10: Stability and Reactivity Text Annex II This section of the safety data sheet shall describe the stability of the substance or mixture and the possibility of hazardous reactions occurring under certain conditions of use and also if released into the environment, including, where appropriate, a reference to the test methods used. If it is stated that a particular property does not apply or if information on a particular property is not available, the reasons shall be given. 2 3 Stability and reactivity are a function of the physical and chemical properties measured to 4 determine values quoted in Section 9 of the SDS. However, although not explicitly stated in 5 the Regulation, historically the practice has been to use Section 9 to indicate measurable 6 properties derived from test procedures whereas Section 10 gives (qualitative) descriptions of 7 possible consequences. Thus, as already explained in subchapter 3.9, Section 9 invites 8 information on “properties” or “parameters” whereas Section 10 specifies that a “description” 9 should be given. 10 Similarly some information may also be given in Section 7 of the SDS (e.g. on incompatibilities 11 in subsection 7.2). In such cases repetition may be avoided by cross-references, with the 12 content of Section 10 focusing on description of hazards and their consequences. Where 13 information is correctly already inserted in a different section of the SDS a cross-reference to it 14 can be made without the need to repeat it. Thus, for example, certain information on hazard 15 classes is included in Section 9 or Section 7. Additionally, information on protection measures 16 is given under subsection 8.2. “exposure controls”. Therefore a lot of information relevant to 17 Section 10 may already be given in other sections. 18 As the information must be written in a clear and concise manner, repetitions should be 19 avoided. 20 21 10.1 Reactivity Text Annex II 10.1.1. The reactivity hazards of the substance or mixture shall be described. Specific test data shall be provided for the substance or mixture as a whole, where available. However, the information may also be based on general data for the class or family of substance or mixture if such data adequately represent the anticipated hazard of the substance or mixture. 10.1.2. If data for mixtures are not available, data on substances in the mixture shall be provided. In determining incompatibility, the substances, containers and contaminants that the substance or mixture might be exposed to during transportation, storage and use shall be considered. 22 23 [The text above is considered as needing no further explanation] 24 25 26 27 79 1 10.2 Chemical stability Text Annex II It shall be indicated if the substance or mixture is stable or unstable under normal ambient and anticipated storage and handling conditions of temperature and pressure. Any stabilisers which are, or may need to be, used to maintain the chemical stability of the substance or mixture shall be described. The safety significance of any change in the physical appearance of the substance or mixture shall be indicated. 2 3 Examples of common standard phrases which may be used in this subsection for stable 4 substances or mixtures include: 5  “Under storage at normal ambient temperatures (minus 40° C to + 40° C), the product 6 is stable.” 7  “No hazardous reaction when handled and stored according to provisions.” 8  “No known hazardous reactions” 9 10 10.3 Possibility of hazardous reactions Text Annex II If relevant, it shall be stated if the substance or mixture will react or polymerise, releasing excess pressure or heat, or creating other hazardous conditions. The conditions under which the hazardous reactions may occur shall be described. 11 12 Note that information e.g. on dust explosion hazard is given in Sections 2 and 9, and there is 13 therefore a need to check for consistency/potential overlap. 14 There is also potential overlap between subsection “10.1 Reactivity” which also relates to 15 reactivity hazards and the present 10.3 “Possibility of hazardous reactions”. Entry of 16 information in subsection 10.3 may be restricted to hazardous outcomes resulting from specific 17 reactivity. Thus clearly, for example, a substance may be described as a strong acid in 18 subsection 10.1 which implies e.g. an intrinsic risk of hazardous reaction with bases. 19 Subsection 10.3 may be reserved for the specific outcomes of reactivity listed (polymerisation 20 leading to excess pressure or heat and for information on reaction conditions. There is no need 21 to duplicate content in both subsections. 22 23 10.4 Conditions to avoid Text Annex II Conditions such as temperature, pressure, light, shock, static discharge, vibrations or other physical stresses that might result in a hazardous situation shall be listed and if appropriate a brief description of measures to be taken to manage risks associated with such hazards shall be given. 24 25 The content of this subsection potentially overlaps with subsection 7.2“Conditions for safe Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 81 1

Storage

including any incompatibilities” and there is therefore a need to check for 2 consistency/potential overlap, 3 The advice provided must be consistent with the physical and chemical properties described in 4 Section 9 of the SDS. If relevant, advice must be provided on specific storage requirements 5 including: 6 (a) How to manage risks associated with: 7 (i) explosive atmospheres; 8 (ii) corrosive conditions; 9 (iii) flammability hazards; 10 (iv) incompatible substances or mixtures; 11 (v) evaporative conditions; and 12 (vi) potential ignition sources (including electrical equipment). 13 (b) How to control the effects of: 14 (i) weather conditions; 15 (ii) ambient pressure; 16 (iii) temperature; 17 (iv) sunlight; 18 (v) humidity; and 19 (vi) vibration. 20 (c) How to maintain the integrity of the substance or mixture by the use of: 21 (i) stabilisers; and 22 (ii) anti-oxidants. 23 (d) Other advice including: 24 (i) ventilation requirements; 25 (ii) specific designs for storage rooms or vessels (including retention walls and 26 ventilation); 27 (iii) quantity limits under storage conditions (if relevant); and 28 (iv) packaging compatibilities 29 30 31 81 1 10.5 Incompatible materials Text Annex II Families of substances or mixtures or specific substances, such as water, air, acids, bases, oxidising agents, with which the substance or mixture could react to produce a hazardous situation (like an explosion, a release of toxic or flammable materials, or a liberation of excessive heat) shall be listed and if appropriate a brief description of measures to be taken to manage risks associated with such hazards shall be given. 2 3 Note that it is not necessarily good practice to give a long list of “incompatible materials” which 4 includes many substances with which the product is unlikely ever to come into contact. A 5 balance should be sought between diluting the message about relevant incompatibilities with 6 too long a list and the potential risks from omission of a specific incompatible material. Use of 7 substance types or classes (e.g. “aromatic solvents”) rather than listing individual substances 8 may be preferable and can avoid long lists of individual substances. 9 The content of this subsection potentially overlaps with elements dealing with handling of 10 incompatible substances and mixtures within subsection 7.1 “Precautions for safe handling” 11 and there is therefore a need to check for consistency/potential overlap. 12 13 10.6 Hazardous decomposition products Text Annex II Known and reasonably anticipated hazardous decomposition products produced as a result of use, spill and heating shall be listed. Hazardous combustion products shall be included in Section 5 of the safety data sheet. 14 15 The possibility of degradation to unstable products should be addressed in this subsection. 16 Examples of common standard phrases which may be used where appropriate in this 17 subsection for stable substances or mixtures include: 18  “Does not decompose when used for intended uses.” 19  “No known hazardous decomposition products.” 20 21 An example of how the structure of this section could look is given below: SECTION 10: Stability and reactivity 10.1 Reactivity 10.2 Chemical stability 10.3 Possibility of hazardous reactions 10.4 Conditions to avoid Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 83 10.5 Incompatible materials 10.6 Hazardous decomposition products 1 2 This section needs to be checked for consistency in particular with the following sections; 3 4  SECTION 5: Fire-fighting measures 5  SECTION 6: Accidental release measures 6  SECTION 7: Handling and storage 7  SECTION 13: Disposal considerations 8 9 3.11 SDS SECTION 11: Toxicological information Text Annex II This section of the safety data sheet is meant for use primarily by medical professionals, occupational health and safety professionals and toxicologists. A concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects shall be provided, including where appropriate information on toxicokinetics, metabolism and distribution. The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture. 11.1. Information on toxicological effects The relevant hazard classes, for which information shall be provided, are: (a) acute toxicity; (b) skin corrosion/irritation; (c) serious eye damage/irritation; (d) respiratory or skin sensitization; (e) germ cell mutagenicity; (f) carcinogenicity; (g) reproductive toxicity; (h) STOT-single exposure; (i) STOT-repeated exposure; (j) aspiration hazard. These hazards shall always be listed on the safety data sheet. For substances subject to registration, brief summaries of the information derived from the application of Annexes VII to XI shall be given, including, where appropriate, a reference to the test methods used. For substances subject to registration, the information shall also include the 83 result of the comparison of the available data with the criteria given in Regulation (EC) No 1272/2008 for CMR, categories 1A and 1B, following point 1.3.1 of Annex I to this Regulation. 11.1.1. Information shall be provided for each hazard class or differentiation. If it is stated that the substance or mixture is not classified for a particular hazard class or differentiation, the safety data sheet shall clearly state whether this is due to lack of data, technical impossibility to obtain the data, inconclusive data or data which are conclusive although insufficient for classification; in the latter case the safety data sheet shall specify “based on available data, the classification criteria are not met.” 11.1.2. The data included in this subsection shall apply to the substance or mixture as placed on the market. In the case of a mixture, the data should describe the toxicological properties of the mixture as a whole, except if Article 6(3) of Regulation (EC) No 1272/2008 applies. If available, the relevant toxicological properties of the hazardous substances in a mixture shall also be provided, such as the LD50, Acute Toxicity Estimates or LC50. 11.1.3. Where there is a substantial amount of test data on the substance or mixture, it may be necessary to summarise results of the critical studies used, for example by route of exposure. 11.1.4. Where the classification criteria for a particular hazard class are not met, information supporting this conclusion shall be provided. 11.1.5. Information on likely routes of exposure Information shall be provided on likely routes of exposure and the effects of the substance or mixture via each possible route of exposure, that is, through ingestion (swallowing), inhalation or skin/eye exposure. If health effects are not known, this shall be stated. 11.1.6. Symptoms related to the physical, chemical and toxicological characteristics Potential adverse health effects and symptoms associated with exposure to the substance or mixture and its ingredients or known by-products shall be described. Available information shall be provided on the symptoms related to the physical, chemical, and toxicological characteristics of the substance or mixture following exposure related to the intended uses specified in Subsection 1.2. The first symptoms at the lowest exposures through to the consequences of severe exposure shall be described, such as “headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death”. 11.1.7. Delayed and immediate effects as well as chronic effects from short and long term exposure Information shall be provided on whether delayed or immediate effects can be expected after short or long term exposure. Information on acute and chronic health effects relating to human exposure to the substance or mixture shall also be provided. Where human data are not available, animal data shall be summarised and the species clearly identified. It shall be indicated whether toxicological data is based on human or animal data. 11.1.8. Interactive effects Information on interactions shall be included if relevant and available. 11.1.9. Absence of specific data It may not always be possible to obtain information on the hazards of a substance or mixture. In cases where data on the specific substance or mixture are not available, data on similar substances or mixtures if appropriate, may be used, provided the relevant similar substance or mixture is identified. Where specific data are not used, or where data are not available, this shall be clearly stated. Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 85 11.1.10. Mixtures For a given health effect, if a mixture has not been tested for its health effects as a whole, relevant information on relevant substances listed under Section 3 shall be provided. 11.1.11. Mixture versus substance information 11.1.11.1. The substances in a mixture may interact with each other in the body resulting in different rates of absorption, metabolism and excretion. As a result, the toxic actions may be altered and the overall toxicity of the mixture may be different from that of the substances in it. This shall be taken into account when providing toxicological information in this section of the safety data sheet. 11.1.11.2. It is necessary to consider whether the concentration of each substance is sufficient to contribute to the overall health effects of the mixture. The information on toxic effects shall be presented for each substance, except for the following cases: (a) if the information is duplicated, it shall be listed only once for the mixture overall, such as when two substances both cause vomiting and diarrhoea; (b) if it is unlikely that these effects will occur at the concentrations present, such as when a mild irritant is diluted to below a certain concentration in a non-irritant solution; (c) where information on interactions between substances in a mixture is not available, assumptions shall not be made and instead the health effects of each substance shall be listed separately. 11.1.12. Other information Other relevant information on adverse health effects shall be included even when not required by the classification criteria. 1 2 This section is of great importance during the process of compilation of an SDS as it should 3 reflect the information gathered and conclusions arrived at during the assessment of the 4 substance or mixture for the purposes of determining its hazards and consequent classification 5 and labelling. 6 It follows from the introductory text to Section 11 that, for mixtures containing substances 7 subject to registration the information given in this section for such substances should also be 8 consistent with that given in the relevant registrations for the individual substances. 9 Since a large quantity of information may need to be provided under this section, particularly 10 in an SDS for a mixture, it is advisable to arrange its layout in such a way that a clear 11 separation is established between the data that apply to a mixture as a whole (where 12 applicable) and that for individual (component) substances. Information concerning the 13 different hazard classes should be clearly and separately reported. 14 Clear and concise presentation of key information and critical studies provided can, for 15 example, be achieved by using text boxes or tables. 16 If no data are available for certain hazard classes or differentiations the reasons for the 85 1 absence of data should be given93. 2 Note that for the requirements given under points 11.1.8 the phrase "if relevant and available" 3 in the context of information on interactive effects is to be understood as meaning that the 4 compiler of the SDS is expected to make a reasonable search for such information if he does 5 not have it already. 6 7 TOXICOLOGICAL (HEALTH) EFFECTS 8 In this subsection of the SDS the potential adverse health effects/symptoms after exposure to 9 the substance, mixture and known by-products must be described. The symptoms caused by 10 the physical, chemical, and toxicological characteristics of the substance or mixture must be 11 listed. Symptoms occurring after exposure should be arranged in a sequential order of 12 exposure levels (either from high to low or from low to high), indicating if occurrence of the 13 effects is immediate or delayed. 14 15 FOR SUBSTANCES 16 Information (such as for example key results) must be provided, for the relevant hazard 17 classes or differentiations, as specified in the legal text quoted above. This should be separated 18 according to the route of exposure, species (rat, mouse, human …), and study duration and 19 study method. In the case of information on specific target organ toxicity (STOT), the 20 information should obviously include indication of the specific target organ. If data are not 21 available for a specific substance and read-across or QSAR’s are applied this should be clearly 22 mentioned. For substances subject to registration brief summaries of the information derived 23 from application of Annex VII to XI (to REACH – i.e. of the results of testing (including non- 24 animal testing) or other alternative means of generating information required for registration 25 purposes) must be given with a short reference, where appropriate, to the test methods used. 26 It should be noted that it is a requirement that other relevant information on adverse health 27 effects must be included even when not required by the classification criteria. 28 29 FOR MIXTURES 30 For mixtures, it should be noted that the requirements for information were different according 31 to Annex I of Commission Regulation (EU) No 453/2010 and the Annex of Commission 32 Regulation (EU) No xxx/xx (i.e. the versions of Annex II of REACH in force from 1 December 33 2010 and that in force from 1 June 2015). Until 1 June 2015 it was information on relevant 34 effects (based on DPD), as listed above, which were to be provided. Since 1 June 2015, the 35 relevant hazard classes (based on CLP) for which information must be provided are the 36 same as for substances (indeed the corresponding legal text no longer differentiates between 37 the requirements for substances and mixtures with respect to these hazard classes). However 38 it should be noted that in the case of mixtures for which relevant information on the 39 component substances is available (e.g. LD50, acute toxicity estimates (ATE), LC50) this must 40 also be provided in addition to information applying to the mixture as placed on the market. 41 For further information on how mixtures should be classified reference should be made to the 42 CLP regulation itself (in particular Article 6 of CLP). 43 When a mixture has been classified according to CLP using an Acute Toxicity Estimate (ATE), 93 As required by point 11.1.1 of the legal text quoted above . Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 87 1 the value of the calculated ATEmix should be included in this subsection, for example using a 2 structure as follows: ATEmix (oral) = xxx mg/kg ATEmix (dermal) = yyy mg/kg ATEmix (inhal.) = z mg/l/4 h (vapours) 3 4 If information on the mixture itself is not available for a certain hazard class or differentiation 5 but several substances in it have the same health effect, this effect may be mentioned for the 6 mixture and not for the individual substances. 7 In the absence of specific data on the mixture regarding interactions between component 8 substances, assumptions must not be made and instead the relevant health effects of each 9 substance must be listed separately (see Annex II point 11.1.12.2.) 10 It should be noted that, as for substances, it is a requirement that other relevant information 11 on adverse health effects must be included even when not required by the classification 12 criteria. 13 This section needs to be checked for consistency in particular with the following sections: 14 15