New Substances Notification Regulations (Chemicals and Polymers) (SOR/2005-247)

1 The information specified in Schedules 4 and 5 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 chemical:

• (a) one of an infra-red, ultra-violet, mass or nuclear magnetic resonance spectrum suitable for characterization of the chemical;

• (b) for chemicals having a water solubility of greater than or equal to 200 µg/L, adsorption-desorption screening test data; and

• (c) for chemicals having a water solubility of greater than or equal to 200 µg/L, its hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis.

3 Data from the two tests mentioned in item 5 of Schedule 5 for which data was not submitted under that item, namely, the remaining two out of the following three tests: acute fish, daphnia and algae toxicity tests. ^*

4 Unless the chemical boils below 0°C and has been tested for acute inhalation toxicity under item 6 of Schedule 5, data from one of the remaining types of acute mammalian toxicity test of the chemical, namely, oral, dermal or inhalation, that was not completed for the submission of item 6 of Schedule 5 and that is selected on the basis of the most significant route of potential human exposure to the chemical. ^*

5 Information sufficient to assess skin irritation in respect of the chemical. ^*

6 Data from a skin sensitization test in respect of the chemical. ^*

7 Data from one repeated-dose mammalian toxicity test in respect of the chemical, of at least 28 days duration, which test is selected on the basis of the most significant route of potential human exposure to the chemical, namely, oral, dermal or inhalation. ^*

8 For the tests referred to in items 4 to 7, the following additional information:

• (a) the age, sex, number, species, strain and source of the animals tested;

• (b) the route by which the chemical is administered and the conditions under which the test is conducted; and

• (c) the dose of the chemical, the vehicle by means of which the chemical is administered and the concentration of the chemical in the vehicle. ^*

9 Mutagenicity data obtained from one in vitro test in respect of the chemical, with and without metabolic activation, for chromosomal aberrations in mammalian cells. ^*

10 Mutagenicity data obtained from one in vivo mammalian test of the chemical for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with data substantiating that the tissue investigated was exposed to the chemical or its metabolites, permits an assessment of in vivo mutagenicity. ^*

11 The following exposure information respecting the chemical:

• (a) its historical and other likely uses; and

• (b) any factors that may limit environmental exposure.

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).