New Substances Notification Regulations (Chemicals and Polymers)
1 The information specified in Schedule 9 or, if that information has been previously provided, the date (year, month, day) of the submission of that information and, if they are known, the new substances pre-notification consultation number, if it has been assigned, and the new substances notification number.
2 The following physical and chemical data in respect of the polymer:
(a) its physical state;
(b) whether it is formulated for dispersal in water;
(c) its water extractability measured at
(d) its octanol-water partition coefficient; and
(e) if water extractability is determined to be greater than 2%, its hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis.
3 Data from a ready biodegradation test on the water-soluble portion of the polymer, unless the polymer has a water extractability at pH 7 of less than or equal to 2% or is a branched silicone or siloxane polymer. *
4 Unless the polymer has a water extractability at pH 7 of less than or equal to 2%, the following tests:
(a) if the sensitivity of the three species is known, an acute toxicity test of the polymer for each of the two most sensitive species: fish, daphnia or algae;
(b) if the sensitivity of only one species is known and that species is not algae, an acute algae toxicity test and either a fish or daphnia acute toxicity test selected on the basis of the most sensitive of these species; or
(c) if the sensitivity of only one species is known and that species is algae or if the sensitivity of the three species is unknown, an acute algae toxicity test and either a fish or daphnia acute toxicity test. *
5 Data from one acute mammalian oral toxicity test of the polymer. *
6 Information sufficient to assess skin irritation in respect of the polymer. *
7 Data from a skin sensitization test in respect of the polymer. *
8 Data from one repeated-dose mammalian toxicity test in respect of the polymer, of at least 28 days duration, which test is selected on the basis of the most significant route of potential human exposure to the polymer, namely, oral, dermal or inhalation. *
9 For the tests referred to in items 5 to 8, the following additional information:
(a) the age, sex, number, species, strain and source of the animals tested;
(b) the route by which the polymer is administered and the conditions under which the test is conducted; and
(c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. *
10 Mutagenicity data obtained from each of the following tests of the polymer:
(a) one in vitro test, with and without metabolic activation, for gene mutations;
(b) one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and
(c) one in vivo mammalian test, for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with data substantiating that the tissue investigated was exposed to the polymer or its metabolites, permits an assessment of in vivo mutagenicity. *
11 The following exposure information respecting the polymer:
(a) a description of the expected modes for its transportation and storage;
(b) a description of the size and type of container used for its transportation and storage;
(c) an identification of the components of the environment into which it is anticipated to be released;
(d) its anticipated releases into municipal wastewater systems;
(e) a description of the methods recommended for its destruction or disposal;
(f) its historical and other likely uses; and
(g) any factors that may limit environmental exposure.
12 A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer or to which they ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer.
Note: The asterisks (*) appearing at the end of certain provisions indicate that laboratory practices to be followed in developing data for the test referred to in that provision must comply with those practices set out in the “Principles of Good Laboratory Practice”. See subsection 15(2) of the New Substances Notification Regulations (Chemicals and Polymers).
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