Vol. 150, No. 7 — April 6, 2016

16259-5 N-P

2-Propenoic acid, 2-methyl-, carbomonocyclic ester, polymer with 2-ethylhexyl 2-methyl-2-propenoate, 2-ethylhexyl 2-propenoate and substituted ethyl 2-methyl-2-propenoate, tert-Bu ethaneperoxoate initiated

Méthacrylate de carbomonocycle polymérisé avec du méthacrylate de 2-éthylhexyle, de l’acrylate de 2-éthylhexyle et du méthacrylate d’éthyle substitué, amorcé avec de l’éthaneperoxoate de tert-butyle

18920-2 N-P

Oxirane, 2-methyl-, polymer with oxirane, monoester with α-[[[3-(carboxyamino)methylphenyl]amino]carbonyl]-ω-alkoxypoly(oxy-1,2-ethanediyl), alkylalkyl ether

Méthyloxirane polymérisé avec de l’oxirane, mono‌ester avec l’α-[[[3-(carboxyamino)méthylphényl]amino]carbonyl]-ω-alcoxypoly(oxyéthane-1,2-diyle), oxyde alkylakylique

18922-4 N-P

2,5-Furandione, telomer with ethenylbenzene and (1-methylethyl)benzene, ester with 2-methyloxirane polymer with oxirane mono(alkylalkyll) ether, potassium salt

Furane-2,5-dione télomérisé avec du styrène et du (propane-2-yl)benzène, ester avec un oxyde mono(alkylalkylique) de méthyloxirane polymérisé avec de l’oxirane, sel de potassium

18924-6 N

Sodium, [μ4-(tricyclo[1.1.0.0^2,4]tetrasilane-1,2,3,4-tetrayl)]poly-

[µ4-(Tricyclo[1.1.0.0^2,4]tétrasilane-1,2,3,4-tétrayl)]polysodium

18925-7 N-P

Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with α-[2,2-bis(hydroxymethyl)alkyl]-ω-methoxypoly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)] and 5-(isocyanato-1-isocyanatomethyl)-1,3,3-trimethylcyclohexane, compd. with N,N-diethylethanamine

Acide 2,2-bis(hydroxyméthyl)propanoïque polymérisé avec de l’α-[2,2-bis(hydroxyméthyl)alkyl]-ω-méthoxypoly(oxyéthane-1,2-diyle), de l’α-hydro-ω-hydroxypoly[oxypropane-1,2-diyle] et du 5-isocyanato-1-isocyanatométhy-1,3,3-triméthylcyclohexane, composés avec de la N,N-diéthyléthanamine

18926-8 N-P

Hexanedioic acid, polymer with 1,3-bis(1-isocyanato-1-methylethyl)benzene, 1,4-cyclohexanedimethanol, 2,2-dimethyl-1,3-propanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 1,1′-methylenebis[4-isocyanatocyclohexane] and 2-methyl-1,5-pentanediamine, 2-methyl-alkanamine-blocked, compds. with triethylamine

Acide hexanedioïque polymérisé avec du 1,3-bis(2-isocyanatopropane-2-yl)benzène, du cyclohexane-1,4-diméthanol, du 2,2-diméthylpropane-1,3-diol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 1,1′-méthylènebis[4-isocyanatocyclohexane] et de la 2-méthylpentane-1,5-diamine, séquencé avec une 2-méthyl-alcanamine, composés avec de la N,N-diéthyléthanamine

18931-4 N-P

1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,3-dihydro-1,3-dioxo-5-isobenzofurancarboxylic acid, hexanedioic acid, methyl-alkanediol and 2,2′-oxybis[ethanol]

Acide isophtalique polymérisé avec de l’acide téréphtalique, de l’acide 1,3-dihydro-1,3-dioxo-2-benzofurane-5-carboxylique, de l’acide hexanedioïque, un méthylalcanediol et du 2,2′-oxybis[éthanol]

18932-5 N-P

Terpolymer of ethyl acrylate, methacrylic acid, and poly(oxy-1,2-ethanediyl), alpha-[[1-methyl-1-[3-(1-methylethenyl)phenyl]ethyl]iminocarbonyl]-omega-alkanyloxy-

Terpolymère d’acrylate d’éthyle, d’acide méthacrylique et d’alpha-[[2-[3-(prop-1-én-2- yl)phényl]propane-2-yl]azanediylcarbonyl]-oméga-alkyloxypoly(oxyéthane-1,2-diyle)

18933-6 N-P

Fatty acids, unsatd., dimers, ester with polyethylene-polypropylene glycol, monoalkylalkyl ether

Dimères d’acides gras insaturés, diesters avec de l’oxyde de poly(éthane-1,2-diol-propane-1,2-diol) et de mono(alkylalkyle)

18934-7 N-P

Poly[oxy(alkyl alkane)], alpha-Phenyl-omega-hydroxy-, ar-polyisobutylene derivs.

alpha-Phényl-oméga-hydroxypoly[oxyalkylalcanediyle], dérivés ar-polyisobutyléniques

18935-8 N-P

Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with adipic acid, 1,3-bis(1-isocyanato-1-methylethyl)benzene, 2,3-dihydroxypropyl methacrylate, dioxa-diazaalkane-tetrol, 2-ethylhexyl acrylate, 1,6-hexanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, isophthalic acid and Me methacrylate, compds. with 2-(dimethylamino)ethanol

Dimères d’acides gras insaturés en C18, hydrogénés, polymérisés avec de l’acide hexanedioïque, du 1,3-bis(2-isocyanatopropane-2-yl)benzène, du méthacrylate de 2,3-dihydroxypropyle, un dioxa-diazaalcane-tétraol, de l’acrylate 2-éthylhexyle, de l’hexane-1,6-diol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 5-isocyanato-1-isocyanatométhyl-1,3,3-triméthylcyclohexane, de l’acide isophtalique et du méthacrylate de méthyle, composés avec du 2-(diméthylamino)éthanol

18923-5 N-P- S

• 1 Any use of the substance silicic acid, sodium salt, hydrolysis products with 1- (substitutedmethoxy)alkyl]silanetriol in a quantity greater than 1 000 kg in a calendar year, other than its use as a component of
  • (a) a coating that is applied in an industrial setting and in which the substance becomes part of a solid matrix once the coating has cured;
  • (b) a waterborne floor coating that is a consumer product, as defined in section 2 of the Canada Consumer Product Safety Act, that is not intended to be applied by spraying and in which the substance becomes part of a solid matrix once the coating has cured; and
  • (c) a pigment or ink that is contained in a cartridge or refill bottle.
• 2 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which it begins:
  • (a) a description of the significant new activity in relation to the substance;
  • (b) the anticipated annual quantity of the substance to be used;
  • (c) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
  • (d) the analytical information that is necessary to determine the primary and secondary particle size of the substance;
  • (e) the information that is necessary to determine the agglomeration and aggregation state, shape, surface area and surface charge of the substance;
  • (f) a description of the manufacturing process, including a description of the substance’s precursors, the reaction stoichiometry and the nature (batch or continuous) and scale of the process;
  • (g) the following information respecting the substance’s identity:
    • (i) its molecular formula,
    • (ii) its structural formula,
    • (iii) its gram molecular weight or number average molecular weight,
    • (iv) the degree of purity in its technical grade composition, if applicable,
    • (v) the known impurities in its technical grade composition and their concentration by weight, and
    • (vi) the additives, stabilizers and solvents present when the substance is tested as set out in this section and their concentration by weight;
  • (h) the following information respecting exposure to the substance:
    • (i) a description of the expected modes for its transportation and storage,
    • (ii) a description of the size and type of container used for its transportation and storage,
    • (iii) an identification of the components of the environment into which it is anticipated to be released,
    • (iv) the quantity that is anticipated to be released into municipal wastewater systems,
    • (v) a description of the methods recommended for its destruction or disposal,
    • (vi) whether it is anticipated to be used in products intended for use by or for children,
    • (vii) the anticipated degree of direct human exposure to the substance, including concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure,
    • (viii) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed in the course of the significant new activity and the estimated quantity by site,
    • (ix) its historical and other likely uses, and
    • (x) any factors that may limit environmental exposure to the substance;
  • (i) the following information respecting mammalian toxicity:
    • (i) the test data and a test report from an in vivo mammalian test for chromosomal aberrations or gene mutations in respect of the substance,
    • (ii) if the significant new activity involves the use of the substance as a component of a consumer product, as defined in section 2 of the Canada Consumer Product Safety Act, that is intended to be applied by spraying, the test data and a test report from
      • (A) a test on the substance’s subchronic inhalation toxicity, including a 90-day satellite (reversibility) study that is conducted in accordance with the methodology described in the Organisation for Economic Co-operation and Development (OECD) Test Guideline No. 413, entitled Subchronic Inhalation Toxicity: 90-Day Study, that is current at the time the test data are developed, and
      • (B) a test on the bronchoalveolar lavage that is conducted immediately following the last exposure and recovery in the test referred to in clause (A) and in accordance with the methodology described in the OECD Series on Testing and Assessment, Publication No. 125, entitled Guidance Document on Histopathology for Inhalation Toxicity Studies, Supporting TG 412 (Subacute Inhalation Toxicity: 28-Day Study) and TG 413 (Subchronic Inhalation Toxicity: 90-Day Study), that is current at the time the test data are developed, and
    • (iii) the test data and a test report on the presence of epoxide groups in the molecular structure of the substance and
      • (A) if the test data indicates that epoxide groups remain in the molecular structure of the substance, the test data and a test report from a repeated dose and reproductive screen study in respect to the substance that is conducted in accordance with the methodology described in the OECD Test Guideline No. 422, entitled Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, that is current at the time the test data are developed, and
      • (B) if the test data indicates that no epoxide groups remain in the molecular structure of the substance and the significant new activity may lead to oral exposure in humans, the test data and a test report from a repeated dose oral study in respect of the substance that is conducted in accordance with the methodology described in the OECD Test Guideline-No. 407, entitled Repeated Dose 28-Day Oral Toxicity Study in Rodents, that is current at the time the test data are developed,
  • (j) if the significant new activity involves the use of the substance in quantities greater than 10 000 kg in a calendar year, the test data and a test report from a test that is conducted in accordance with the methodology described in the OECD Test Guideline No. 225, entitled Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment, that is current at the time the test data are developed;
  • (k) the following information regarding each test substance that is administered in the tests referred to in paragraphs (i) and (j):
    • (i) the analytical information that is necessary to determine its primary and secondary particle size, and
    • (ii) the information that is necessary to determine its agglomeration and aggregation state, shape, surface area and surface charge; and
  • (l) all other information or test data in respect of the substance that are in the possession of the person who is proposing to conduct the significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.
• 3 If the significant new activity involves the use of the substance with an associated substrate, the information required under section 2 must also be provided in relation to the substance with the associated substrate.
• 4 The test data and the test reports referred to in sections 2 and 3 must be
  • (a) developed in accordance with the practices described in the OECD Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981 by the OECD, using the Principles of Good Laboratory Practice that is current at the time the test data are developed; and
  • (b) conducted in accordance with the principles described in the following publications from the OECD Series on the Safety of Manufactured Nanomaterials, using the versions that are current at the time the test data are developed:
    • (i) Publication No. 36, entitled Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials,
    • (ii) Publication No. 40, entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, and
    • (iii) Publication No. 41, entitled Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines.
• 5 The information provided under sections 2 and 3 will be assessed within 90 days after the day on which it is received by the Minister.