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Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers
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APPENDIX 8 - Examples of Waiver Conditions
- 1.0 Physical and Chemical Data
- 1.1 Examples of Justifications
- 1.1.1 Density
- 1.1.2 Vapour Pressure
- 1.1.3 Water Solublility
- 1.1.4 Partition Coefficient
- 1.1.5 Adsorption-Desorption
- 1.1.6 Hydrolysis as a Function of pH (Screening
Portion)
- 1.1.7 Number-average Molecular Weight
- 1.1.8 Concentration of Residual Constituents
- 1.1.9 Ultraviolet-Visible Spectrum
- 2.0 Ecotoxicological Data
- 3.0 Health Toxicity Data
- 3.1 Examples of Justifications
- 3.1.1 Acute Toxicity (Oral, Dermal, or Inhalation)
- 3.1.2 Repeated Dose Toxicity (Oral, Dermal,
or Inhalation)
- 3.1.3 Skin Irritation
- 3.1.4 Skin Sensitization
- 3.1.5 In Vitro
Gene Mutation
- 3.1.6 In Vitro Mammalian
Chromosomal Abberation
- 3.1.7 In Vivo
Mammalian Mutagenicity
The requirement to provide test data on a chemical or polymer
may be waived if sufficient justification is given. Examples of conditions
under which waivers may be granted by the Minister
are described below. These and other conditions for accepting a waiver
of information will be considered on a case-by-case basis.
1.0 Physical and Chemical Data
Generally applicable:
a) if the chemical properties or physical form
of the substance preclude(s) the adequate conduct of the test. The rationale
should provide sound reasoning as to why it is not technically feasible
or practicable to conduct the test; and
b) if the substance cannot be
isolated from the reaction medium in which it is formed and information
generated on the mixture would not be meaningful for the assessment of
the notified substance. Information documenting efforts to isolate the
substance should be provided.
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1.1 Examples of Justifications
1.1.1 Density
The substance is only stable in solution in a particular solvent and
the solution density is similar to that of the solvent. In such cases,
an indication of whether the solution density is higher or lower than
the solvent density would be sufficient.
1.1.2 Vapour Pressure
The substance is unstable in the purified form.
1.1.3 Water Solublility
- The substance reacts dangerously with water (e.g., liberates
a poisonous gas).
- The substance is highly volatile; therefore, determination of water
solubility is not technically feasible.
- The substance forms a stable emulsion in water which cannot be separated
by filtration or centrifugation methods.
1.1.4 Partition Coefficient
- The substance decomposes or reacts dangerously during the performance
of the test.
- The substance is surface active.
1.1.5 Adsorption-Desorption
- The solubility of the substance in water cannot be measured analytically;
therefore, determination of adsorption is not technically feasible.
- The substance decomposes (e.g., biodegradation or hydrolysis)
or reacts dangerously during the performance of the test.
1.1.6 Hydrolysis as a Function of pH (Screening
Portion)
- The substance reacts dangerously with water.
- The substance is a member of one or more of these groups and does
not contain other functional groups that could change the hydrolysis
potential of the substance:
Alcohols |
Glycols |
Aldehydes |
Halogenated aromatics |
Alkanes |
Heterocyclic polycyclic aromatic hydrocarbons |
Alkenes |
Hydrocarbons |
Alkynes |
Ketones |
Aromatic amines |
Phenols |
Aromatic nitro compounds |
Polycyclic aromatic hydrocarbons |
Benzenes/Biphenyls |
Sulphonic acids |
Carboxylic acids |
Ethers |
- The substance has no readily hydrolysable groups and therefore is
not expected to hydrolyze.
1.1.7 Number-average Molecular Weight
The polymer cannot be dissolved
in any solvent suitable for use in an analytical method. Information documenting
the efforts to dissolve the polymer should be provided. If the polymer
is soluble at >2%, a GPC should be performed and provided on the soluble
portion of the polymer.
1.1.8 Concentration of Residual Constituents
- The polymer cannot be dissolved
in any solvent suitable for use in an analytical method. Information
documenting the efforts to dissolve the polymer should be provided.
- A residual constituent of the substance cannot be measured analytically;
therefore, determination of its concentration is not technically feasible.
1.1.9 Ultraviolet-Visible Spectrum
The substance is explosive or reacts dangerously in the presence of light.
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2.0 Ecotoxicological Data
The chemical properties or physical form of the substance preclude(s)
the adequate conduct of the test. The rationale should provide sound reasoning
as to why it is not technically feasible or practicable to conduct the
test.
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3.0 Health Toxicity Data
Generally applicable:
- if the chemical properties or physical form of the substance preclude(s)
the adequate conduct of the test. The rationale should provide sound
reasoning as to why it is not technically feasible or practicable to
conduct the test;
- if the substance cannot be isolated from the reaction medium in which
it is formed, and information generated on the mixture would not be
meaningful for the assessment of the notified substance. Information
documenting efforts to isolate the substance should be provided;
- if the polymer does not meet
the criteria for a reduced regulatory requirement polymer solely due
to the presence of the following cationic or potentially cationic groups:
primary, secondary, tertiary amine groups, carbodiimides or sulphoniums.
Cationic groups not specified above, including quarternary amines, hindered
amines, azides, isocyanates (free and blocked) and phosphoniums will
generally not be eligible for waivers of all toxicological test requirements.
They may, however, be considered for waivers of certain requirements
on a case-by-case basis. Polymers with an Mn of greater than
10 000 daltons will generally not be eligible for a waiver of acute
and repeated dose toxicity tests if inhalation is expected to be the
most significant route of exposure of the general population based on
expected type of use; and
- if the polymer does not contain greater than 0.1% species having
molecular weight less than 1000 daltons and available information (e.g.,
potential hydrolysis, biodegradation, toxicity) indicates that the polymer
does not readily break down, and will not be biologically available.
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3.1 Examples of Justifications
3.1.1 Acute Toxicity (Oral, Dermal, or Inhalation)
- The substance is corrosive
or highly irritating, or is expected to be corrosive or highly irritating
based on consideration of factors such as pH and chemical reactivity;
therefore, administration of the substance in accordance with the test
protocol for the acute toxicity test would cause severe and enduring
pain to the test animals.
- It is not technically feasible to administer known doses of the substance
because of its chemical or physical properties (e.g., the substance
is a gas that cannot be dissolved to a detectable level into an appropriate
oral vehicle).
3.1.2 Repeated Dose Toxicity (Oral, Dermal, or
Inhalation)
It is not technically feasible to administer known doses of the substance
because of its chemical or physical properties.
3.1.3 Skin Irritation
- It is not technically feasible to administer the substance topically.
- The substance has demonstrated high acute dermal toxicity; therefore,
administration of the substance in accordance with the test protocol
for skin irritation would cause excessive animal
deaths (e.g., >25%).
3.1.4 Skin Sensitization
- It is not technically feasible to administer the substance topically.
- The substance is corrosive or highly irritating; therefore, administration
of the substance in accordance with the test protocol for skin sensitization
would cause severe and enduring pain to the test animals,
and/ or obscure any skin sensitization reaction.
3.1.5 In Vitro Gene Mutation
- An in vitro mammalian chromosomal aberration assay indicates
that the substance has mutagenic activity.
- An in vivo mammalian genotoxicity assay indicates that the
substance has mutagenic activity.
3.1.6 In Vitro Mammalian Chromosomal Abberation
- An in vitro gene mutation assay indicates that the substance
has mutagenic activity.
- An in vivo mammalian genotoxicity test indicates that the
substance has mutagenic activity.
3.1.7 In Vivo Mammalian Mutagenicity
- The results of both the in vitro gene mutation and the in
vitro mammalian chromosomal aberration tests indicate that the
substance has no mutagenic activity in those tests.
- The intended use of the substance will not involve direct, repeated,
or prolonged human exposure.
- The chemical structure of the substance, or part thereof, is not
related to a known mutagen or carcinogen.
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