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(Reference document: ST/SG/AC.10/C.4/62, annex I) Chapter 3.2 3.2.1.1 Amend to read as follows: “Skin corrosion refers to the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis occurring after exposure to a substance or mixture.

GE.03-30086 (E) 310103 030203 TR A D E/W P.7/G E.6/2003/9 page 2 Disease French name Agent ECE status Recommended diagnostic method Symptoms - vegetation Symptoms - tubers Comment FUNGUS Black dot Dartrose Colletotrichum coccodes Unregulated Visual observation of tubers and identification on selected sites Warm summers: yellowing, curling up and withering of the leaves and stem, and (a typical symptom of early destruction of the roots) sloughing of the epidermis of the roots and formation of numerous black dots At harvest time, slight discoloration with silky microsclerotia.

GE.03-31645 T R A D E /W P.7/G E .6/2003/10/A dd.1 page 2 Disease French name Agent ECE status Recommended diagnostic method Symptoms - vegetation Symptoms - tubers Comment FUNGUS Black dot Dartrose Colletotrichum coccodes Unregulated Visual observation of tubers and identification on selected sites Warm summers: yellowing, curling up and withering of the leaves and stem, and (a typical symptom of early destruction of the roots) sloughing of the epidermis of the roots and formation of numerous black dots At harvest time, slight discoloration with silky microsclerotia.

Table 3.2.1 Replace with the following: "Table 3.2.1: Skin corrosion category and sub-categories a Criteria Category 1 Destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested animal after exposure ≤ 4 h Sub-category 1A Corrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h Sub-category 1B Corrosive responses in at least one animal following exposure 3 min and ≤ 1 h and observations ≤ 14 days Sub-category 1C Corrosive responses in at least one animal after exposures 1 h and ≤ 4 h and observations ≤ 14 days a The use of human data is addressed in 3.2.2.2 and in chapters 1.1 (para. 1.1.2.5(c)), and 1.3 (para. 1.3.2.4.7).” 3.2.2.1.2 Former 3.2.2.5 becomes new 3.2.2.1.2 as amended to read as follows: “3.2.2.1.2 Skin irritation". 3.2.2.1.2.1 Insert a new paragraph to read as follows: “3.2.2.1.2.1 A substance is irritant to skin when it produces reversible damage to the skin following its application for up to 4 hours.” 3.2.2.1.2.2 Former 3.2.2.5.1 becomes new 3.2.2.1.2.2 with the following amendments: • Amend the introductory sentence to read as follows: “An irritation category (Category 2) is provided that:” ST/SG/AC.10/40/Add.3 10 • Delete (a). (...) An example of a validated internationally accepted in vitro test method for skin irritation is OECD Test Guideline 439 (Reconstructed Human Epidermis Test Method); e Measurement of pH alone may be adequate, but assessment of acid or alkali reserve (buffering capacity) would be preferable. (...) Yes No Category 2 Warning ST/SG/AC.10/40/Add.3 19 3.2.5.3.3 In the case of a study with 6 animals the following principles apply: (a) The substance or mixture is classified as skin corrosion Category 1 if destruction of skin tissue (that is, visible necrosis through the epidermis and into the dermis) occurs in at least one animal after exposure up to 4 hours in duration; (b) The substance or mixture is classified as skin irritation Category 2 if at least 4 out of 6 animals show a mean score per animal of ≥ 2.3 and ≤ 4.0 for erythema/eschar or for oedema; (c) The substance or mixture is classified as skin irritation Category 3 if at least 4 out of 6 animals show a mean score per animal of ≥ 1.5 and 2.3 for erythema/eschar or for oedema. 3.2.5.3.4 In the case of a study with 5 animals the following principles apply: (a) The substance or mixture is classified as skin corrosion Category 1 if destruction of skin tissue (that is, visible necrosis through the epidermis and into the dermis) occurs in at least one animal after exposure up to 4 hours in duration; (b) The substance or mixture is classified as skin irritation Category 2 if at least 3 out of 5 animals show a mean score per animal of ≥ 2.3 and ≤ 4.0 for erythema/eschar or for oedema; (c) The substance or mixture is classified as skin irritation Category 3 if at least 3 out of 5 animals show a mean score per animal of ≥ 1.5 and 2.3 for erythema/eschar or for oedema. 3.2.5.3.5 In the case of a study with 4 animals the following principles apply: (a) The substance or mixture is classified as skin corrosion Category 1 if destruction of skin tissue (that is, visible necrosis through the epidermis and into the dermis) occurs in at least one animal after exposure up to 4 hours in duration; (b) The substance or mixture is classified as skin irritation Category 2 if at least 3 out of 4 animals show a mean score per animal of ≥ 2.3 and ≤ 4.0 for erythema/eschar or for oedema; (c) The substance or mixture is classified as skin irritation Category 3 if at least 3 out of 4 animals show a mean score per animal of ≥ 1.5 and 2.3 for erythema/eschar or for oedema.”

S T /S G /A C .1 0 /4 6 /A d d .3 1 8 Table 3.2.6: Skin corrosion criteria for in vitro/ex vivo methods Category OECD Test Guideline 430 (Transcutaneous Electrical Resistance test method) OECD Test Guideline 431 Reconstructed human Epidermis test methods: Methods 1, 2, 3, 4 as numbered in Annex 2 of OECD Test Guideline 431 OECD Test Guideline 435 Membrane barrier test method Using rat skin discs corrosive chemicals are identified by their ability to produce a loss of normal stratum corneum integrity. (...) Four similar methods where the test chemical is applied topically to a three-dimensional reconstructed human epidermis (RhE) which closely mimics the properties of the upper parts of human skin. (...) perforation), and (ii) the subsequent confirmatory testing of positive results using a dye binding step is negative ≥ 35% after 240 min exposure ≥ 50% after 3 min exposure and ≥ 15% after 60 min exposure > 240 min. > 60 min S T /S G /A C .1 0 /4 6 /A d d .3 1 9 Table 3.2.7 Skin irritation criteria for in vitro methods Category Test Guideline 439 Reconstructed Human Epidermis test methods Four similar methods (1-4) where the test chemical is applied topically to a three-dimensional reconstructed human epidermis (RhE) which closely mimics the properties of the upper parts of human skin.

[Skin corrosion refers to the production of irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis occurring after exposure to a substance or mixture.] [A substance is corrosive to skin when it leads to the destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested animal after exposure for up to 4 hours.] 2.8.1.3 Liquids and solids which may become liquid during transport, which are judged not to be skin corrosive shall still be considered for their potential to cause corrosion to certain metal surfaces in accordance with the criteria in 2.8.3.3 (c) (ii). 2.8.2 General classification provisions 2.8.2.1 Substances and mixtures of Class 8 are divided among the three packing groups according to their degree of danger in transport: (a) Packing group I is assigned to very dangerous substances and mixtures; (b) Packing group II is assigned to substances and mixtures presenting medium danger; (c) Packing group III is assigned to substances and mixtures that present minor danger. 2.8.2.2 Allocation of substances listed in the Dangerous Goods List in Chapter 3.2 to the packing groups in Class 8 has been made on the basis of experience taking into account such additional factors as inhalation risk (see 2.8.2.4) and reactivity with water (including the formation of dangerous decomposition products). 2.8.2.3 New substances and mixtures can be assigned to packing groups on the basis of the length of time of contact necessary to produce [full thickness destruction of human skin] in accordance with the criteria in 2.8.3.

A substance is corrosive to skin when it leads to the destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested animal after exposure for up to 4 hours.