3.1 General
This section describes the general requirement for the application data-set specified in
sections 4.2, 5.2 and 5.3 of Procedure (G9).
3.1.1 The dossier should contain the information specified in Procedure (G9). In cases
where information requested in accordance with Procedure (G9) has not been submitted and
no justification for non-submission is provided, the GESAMP-BWWG may not be able to
judge the reasons for not submitting the information that may influence its evaluation
and development of recommendations. A model for the presentation of the application
data-set is given in appendix 3.
3.1.2 For Active Substances and/or Preparations, including any of its components as
appropriate, data on properties should be included. For Relevant Chemicals, data should
be provided as well.
3.1.3 Fate and effect testing should be performed in the laboratory with Active
Substances and Preparations (G9: 5.3.1). However, the GESAMP-BWWG notes that normally
assessment of fate (including degradation, bioaccumulation) is not feasible for
Preparations, but only for individual substances. Therefore, degradation and fate
testing of Preparations may not be appropriate. However, fate of individual substances
of the Preparation should be demonstrated.
3.1.4 For treated ballast water, the Administration should provide both acute and
chronic toxicity data (G9: 5.2.2) at Basic Approval application. The discharge toxicity
tests at Final Approval should include acute and chronic toxicity test methods and
results performed as part of the land-based type approval process with test species
(fish, crustacea and algae). The results should include acute LC50 values and chronic
NOECs (G9: 5.2.5). One hundred per cent concentrations of samples of ballast water
discharge should be tested (G9: 5.2.6), if appropriate.
3.1.5 Any reference to specific test methods in the following is indicative with the
purpose of providing guidance to an Administration on possible methods that may be
considered. Any other internationally recognized test method may be used as well.
3.2 Identification of the substance or Preparation
This section describes the identification of the substance or Preparation specified in
paragraph 4.1 of Procedure (G9).
3.2.1 Preparations
For each Preparation, the application should include the following information (G9:
4.2.2):
3.2.2 Active Substances
For each Active Substance, the applicant should provide the following information:
-
.1 the Trade name (where relevant);
-
.2 the chemical (IUPAC) name;
-
.3 the CAS number;
-
.4 the UN number and proper shipping name (where relevant);
-
.5 the molecular mass;
-
.6 the empirical formula;
-
.7 the structural formula;
-
.8 the classification in accordance with the UN GHS system;
-
.9 the purity of the technical material and identification of impurities (chemical
name and CAS-numbers, etc.); and
-
.10 the identity of any stabilizers or necessary additives.
3.2.3 Relevant Chemicals
3.2.3.1 For identification of all possible Relevant Chemicals that have been produced by
the use of the BWMS, and the corresponding worst case concentrations in treated and
discharged ballast water, chemical analysis should be performed in conjunction with the
efficacy test according to Guidelines (G8), both at Basic Approval and Final
Approval.
3.2.3.2 If chemical analyses were performed during more than one test run, the number of
test runs should be stated and results should be reported in the form of individual
measurements for each test run. Analytical results should be provided for both treated
and control samples.
3.2.3.3 If the tests regarding biological efficacy under Guidelines (G8) are performed
for a shorter period than the storage period according to Procedure (G9) (i.e. 5 days),
it is recommended that the applicant prepares additional treated ballast water to be
kept in a separate tank for the purpose of testing according to Procedure (G9)
(hereafter "5-day storage tank"). In such a case, the same BWMS, including the same test
water, as the one being used during the biological efficacy test, should be used in
order to simulate the ballast water.
3.2.3.4 It is recommended that the volume of the 5-day storage tank should be above 5
m3. Making use of an airtight and dark tank is recommended to prevent any
unexpected photochemical reaction and vaporization of the Relevant Chemicals. The
applicant should verify the representativeness of the treated water that is being kept
in the 5-day storage tank in terms of water quality parameters (i.e. salinity, DOC, POC
and TSS).
3.2.3.5 For identification of the worst case concentrations of Relevant Chemicals during
the testing period, the applicant should collect test water samples at different times
(24 and 48 hours), in addition to the sampling and analysis at 120 hours. The reason is
that some Relevant Chemical concentrations may peak already at 24 or 48 hours.
3.2.3.6 It is recommended that for Basic Approval the tests should be carried out in
ambient temperature conditions.
3.2.3.7 If any post-treatment, such as neutralization, is applied at discharge, sampling
and analysis should be performed both before and after treatment. While making use of a
small-scale BWMS, post-treatment prior to discharge should not be performed
manually.
3.2.3.8 The substances listed in the Database of chemicals most commonly associated with
treated ballast water (hereinafter the Database, appendix 6) should be regarded as the
minimum set of Relevant Chemicals to be analysed if the BWMS uses an Active Substance
that can be characterized as TRO. The detection limit of each target substance has to be
chosen such that it is possible to perform a PEC/PNEC assessment (that is the detection
limit cannot be higher than the respective PNEC). For other types of BWMS, the applicant
should provide their own target list of Relevant Chemicals including scientific
justification. In appendix 7 an overview is given of the recommended detection limits
for the Relevant Chemicals listed in the Database.
3.2.3.9 For Basic Approval the minimum number of sets of samples for Relevant Chemical
identification should be 18, as indicated in the table below.
Table 1: Test waters needed for Relevant Chemical identification in conjunction with
the 2016 Guidelines (G8) for Basic Approval
| Parameter
|
Requirements
|
| Test water type (3)
|
seawater, brackish water and fresh
water
|
| Sample timing (3)
|
24, 48 and 120 hours
|
| Treatment (2)
|
before and after neutralization process
|
| Temperature (1)
|
ambient
|
Note: The numbers in brackets show the minimum number of sets of samples for each
parameter.
3.2.3.10 The minimum holding time for evaluation of Guidelines (G8) efficacy, can be
shorter than five days, as stated in paragraph 2.4.5 in Part 2 of the annex of the 2016
Guidelines (G8). Regardless of the length of holding time, test facilities carrying out
identification of Relevant Chemicals of treated ballast water from test cycles with a
holding time that is shorter than five days should ensure that a sufficient volume of
treated water is reserved after the efficacy testing. The reason is that other Relevant
Chemical concentrations may peak after five days.
3.2.3.11 It is recommended to identify all possible Relevant Chemicals for the Final
Approval in conjunction with the cycle aimed at evaluation of regrowth during the
holding time (2016 Guidelines (G8), annex, paragraph 2.6.1).
3.2.3.12 The full-scale BWMS from the land-based test set-up should be used to prepare
test water for the Relevant Chemical identification. The recommendations described in
paragraphs 3.2.3.6 to 3.2.3.8 should apply. For physicochemical properties of the test
water refer to paragraphs 3.6.17 to 3.6.19.
3.2.3.13 For Final Approval the minimum number of sample situations for Relevant
Chemical identification should be 18 as described under Basic Approval.
3.2.3.14 It is important that the applicant makes use of test water that does not
contain anthropogenic pollutants.
3.2.3.15 All chemicals detected at least once in any test water, stated in paragraph
3.2.3.9 or 3.2.3.13, should be classified as Relevant Chemicals. The applicant should
select the highest concentration for each Relevant Chemical among all samples as the
concentration to be taken forward to the risk assessment.
3.2.3.16 Applicants may propose two worst-case concentrations, one for occupational
assessment (in a ballast water tank) and the other for environmental and general public
risk assessment (in the discharged ballast water).
3.2.3.17 The applicant should provide the following information for those chemicals
deemed to be Relevant Chemicals:
-
.1 the Chemical (IUPAC) name;
-
.2 the CAS number;
-
.3 the molecular mass;
-
.4 the empirical formula;
-
.5 the structural formula; and
-
.6 the classification in accordance with the GHS system.
3.2.4 Other Chemicals
Unless a justification can be provided for not doing so, the following information
should be supplied for Other Chemicals:
-
.1 the Chemical (IUPAC) name;
-
.2 the CAS number;
-
.3 the molecular mass;
-
.4 the empirical formula;
-
.5 the structural formula;
-
.6 the classification in accordance with the GHS system; and
-
.7 if relevant particle size distribution, if in powder and/or granular form, as
smaller particles (< 10 μm) present a greater hazard in potential cases of
inhalation exposure.
3.3 Data on effects on aquatic plants, invertebrates and fish, and other biota,
including sensitive and representative organisms
This section describes the data on effects on aquatic plants, invertebrates and fish,
and other biota, including sensitive and representative organisms specified in paragraph
4.2.1.1 of Procedure (G9).
3.3.1 General
For every Active Substance or Preparation including any of its components, data should
be presented and discussed either on the basis of toxicological tests or published
toxicological knowledge for each end point listed.
3.3.2 Acute aquatic toxicity
3.3.2.1 Short-term L(E)C50 from freshwater or marine
representatives of three taxa (algae, crustacean and fish) representing three trophic
levels by internationally standardized tests, e.g. OECD guidelines 201 (Algae, Growth
Inhibition Test), 202 (Daphnia sp. Acute Immobilization Test), 203 (Fish, Acute
Toxicity Test), US EPA 850.1035 (Mysid shrimp acute toxicity test), and Mysid shrimp
acute toxicity test (US EPA 850.1035) should be accepted. To reduce further any
remaining uncertainty, applicants should, preferably, also submit data for two
additional marine taxa (e.g. echinoderms, molluscs), ISO 10253 (Micro algae), ISO
7346-2, ISO 7346-3 (fish), and ISO 10706 (Daphnia).
3.3.2.2 Such acute aquatic toxicity data should be provided for:
-
.1 Preparations including any of its components;
-
.2 Active Substances;
-
.3 Relevant Chemicals; and
-
.4 discharged ballast water (G9: 5.2.3).
3.3.2.3 For algal toxicity testing, it is recommended that:
-
.1 two species of algae be used in toxicity testing for marine and brackish water.
The same two species should be used for Basic Approval and Final Approval;
-
.2 Skeletonema sp.footnote be used as one of the test species for
marine and brackish water. Test facilities should identify the strains of
Skeletonema sp. used;
-
.3 the second test species not be a diatom for marine and brackish water;
-
.4 Phaeodactylum tricornutum not be used as a test species; and
-
.5 for fresh water, another species rather than those described in the previous
points should be selected.
3.3.3 Chronic aquatic toxicity
3.3.3.1 Long-term NOECs or EC10 from three freshwater or marine species
(normally algae and/or crustacea and/or fish), representing three trophic levels by
internationally standardized tests, e.g. OECD guidelines 201 (algae), 210, 215, or 212
(fish), and 211 (Daphnia), should be acceptable. To reduce any further remaining
uncertainty, applicants should preferably also submit two long-term NOECs from
additional marine taxa (e.g. echinoderms, molluscs), ISO 10253 (micro algae), ISO 20666
(rotifer), and ISO 10229 (fish).
3.3.3.2 Short-term methods by US EPA and ISO for estimating the chronic toxicity of
substances and discharge provide acceptable alternatives, since the identification of
the sensitive sub-lethal endpoints and vulnerable life stages is the ultimate aim of the
long-term testing.
3.3.3.3 Such chronic aquatic toxicity data should be provided for:
-
.1 Preparations including any of its components;
-
.2 Active Substances;
-
.3 Relevant Chemicals; and
-
.4 discharged ballast water (fish, invertebrate, plant) (G9: 5.2.3).
3.3.3.4 For the chronic aquatic toxicity testing using discharged ballast water
(paragraph 3.1.4), based on the experience gained in the evaluation process of BWMS, it
has been shown that, where the BWMS uses an Active Substance that can be characterized
as TRO, there is no need to evaluate the results of chronic ecotoxicity testing using
discharged ballast water. This is because the levels of Relevant Chemicals, such as THMs
and HAAs, have been found to remain in similar concentration ranges that lead to
PEC/PNEC ratios < 1. It is also recognized that with these types of BWMS, Relevant
Chemicals other than the range of well-known chlorinated and brominated low molecular
weight substances are not produced. Therefore, it is considered appropriate that such
BWMS could fully be evaluated at Basic Approval without the results of chronic
ecotoxicity testing. It should be emphasized that this waiver would not apply to BWMSs
other than those systems mentioned and this waiver does not extend to Final
Approval.
3.3.4 Endocrine disruption
3.3.4.1 Regarding the risks connected to endocrine disruption, non-standardized in
vivo as well as in vitro tests may be conducted as long as no
internationally standardized tests are available (e.g. full-life-cycle test on fish or
amphibian metamorphosis assay). When substantial evidence on such effects is available,
this should be taken into account on a case-by-case basis and in the effect assessment
for each compartment of relevance. If there is no indication for endocrine disruption –
e.g. due to the structure of the substance or results of other available studies – these
tests may be waived.
3.3.4.2 Such information on endocrine disruption should be provided for:
3.3.5 Sediment toxicity
3.3.5.1 Substances that are potentially capable of depositing on or adsorbing to
sediments to a significant extent should be assessed for toxicity to sediment-dwelling
organisms. Testing is considered relevant only if log Kow > 3 or if there is
similar adsorption behaviour and should include a maximum of three long-term tests with
species representing different living and feeding conditions, e.g. Chironomus sp.
(OECD 218), Lumbriculus variegates, including a minimum of two tests with marine
species. If sediment toxicity tests are not available, toxicity should be assessed using
established internationally recognized methods such as the equilibrium partitioning
method (EPM) according to the "Technical Guidance Document on Risk Assessment" (TGD) to
the European Biocides Regulation 1107/2009/EC.
3.3.5.2 For substances that are persistent in marine waters or may accumulate in
sediments, a specific marine sediment assessment is necessary.
3.3.5.3 Such information on sediment toxicity should be provided for:
3.3.6 Food web/population effects
3.3.6.1 The biomagnification and persistence in the food web should be discussed based
on the results from aquatic toxicity testing, mammalian toxicity evaluation and
bioaccumulation and biodegradation data.
3.3.6.2 An assessment of secondary poisoning is redundant if, for the substance of
concern, the absence of bioaccumulation potential can be demonstrated (BCF < 500 L/kg
wet weight for the whole organism at 5% fat). If not, testing should include:
3.3.6.3 Such information related to the food web/population effects should be provided
for:
3.4 Data on mammalian toxicity
This section describes the data on mammalian toxicity specified in paragraph 4.2.1.2 of
Procedure (G9).
3.4.1 General
3.4.1.1 Information that is deemed to be scientifically not justified or technically not
feasible need not be supplied. However, in such cases, a scientific justification should
be submitted in order to explain why the data have not been provided. In general,
testing with vertebrate animals should be avoided if another type of information is
available that allows an assessment of hazards and risks to humans. Such alternative
information may be obtained by validated in vitro methods, Quantitative Structure
Activity Relationships (QSAR), and grouping or read-across with similar substances. If
available, human cases or epidemiological evidence should be presented and
discussed.
3.4.1.2 In general, information should be provided on the Active Substance and the
Preparation, including any of its components, as appropriate. Information on Relevant
Chemicals formed during or after application of the BWMS should be provided as well.
3.4.2 Acute toxicity
3.4.2.1 The acute toxicity data should be known for at least two routes of exposure, one
of which should be the oral route. Active Substances or Preparations that are gases
should be assessed in terms of inhalation toxicity.
3.4.2.2 The submission of dermal and/or inhalation studies instead of or in addition to
oral studies may be requested depending on the physico-chemical properties of the
substance, the proposed or potential application of the substance/products.
3.4.2.3 Such information on acute toxicity should be provided for:
3.4.3 Effects on skin and eye
3.4.3.1 Data should provide information on the degree and nature of skin, eye and
associated mucous membrane irritation, especially with regard to the reversibility of
responses. Data should provide sufficient information to assess the potential to cause
skin sensitization reactions. Submitted data should concern testing with the Active
Substance(s) or Preparation(s).
3.4.3.2 Data should include available information concerning a study on acute dermal
irritation/corrosion and a study on acute eye irritation/corrosion. The recommended
tests are OECD guidelines 404 (Acute Dermal Irritation/Corrosion) and 405 (Acute Eye
Irritation/Corrosion). Results from validated in vitro test methods may be
submitted.
3.4.3.3 The recommended test guideline for Skin Sensitization is OECD guideline 406.
While the guinea-pig Maximization test is considered to be the preferred adjuvant
technique in certain cases, there may be good reasons for choosing the Buehler test or
OECD TG 442A the Local Lymph Node Assay (LLNA) and OECD TG 442B (Lymph Node Assay:
BrdU-ELISA). However, scientific justification should be given when either of the two
latter mentioned is used. Information regarding hazard classification as a sensitizer
should be submitted, if available.
3.4.3.4 Such information related to the effects on skin and eyes should be provided
for:
3.4.4 Repeated-dose toxicity
3.4.4.1 Repeated-dose toxicity should be assessed based on data from a sub-chronic
toxicity study (90-day) in two species, one rodent and one other mammalian species,
using the oral route unless another one is more appropriate.
3.4.4.2 Such information on repeated-dose toxicity should be provided for:
3.4.5 Chronic toxicity
3.4.5.1 There is a need for a chronic toxicity assessment based on a study of a minimum
duration of 12 months in two species – one rodent and one other mammalian species –
unless a full justification demonstrates that this test is not necessary.
3.4.5.2 Any chronic study can be combined with a carcinogenicity study.
3.4.5.3 Such information on chronic toxicity should be provided for:
3.4.6 Developmental and reproductive toxicity
3.4.6.1 Data should include information from:
-
.1 a two-generation reproduction and fertility study (OECD guideline 416 –
Two-Generation Reproduction Toxicity Study); and
-
.2 a prenatal developmental toxicity (teratogenicity) study in two species (OECD
guideline 414 – Prenatal Developmental Toxicity).
3.4.6.2 However, this information can be waived provided that an argument is submitted
based on structural relationships with a known reproductive toxicant, the results of
other toxicity studies (including toxicokinetics), and concerns for endocrine
disruption. Such information on developmental and reproductive toxicity should be
provided for:
3.4.7 Carcinogenicity
3.4.7.1 Carcinogenicity data should be submitted based on studies performed with one
rodent and one other mammalian species. In case this information is not provided, a
scientific justification should be submitted.
3.4.7.2 Such information on carcinogenicity should be provided for:
3.4.8 Mutagenicity/genotoxicity
3.4.8.1 This information should address at least three tests: a bacterial gene mutation
test, an in vitro mammalian cell cytogenicity study and an in vitro
mammalian cell gene mutation assay. In case of positive or equivocal results,
further in vivo mutagenicity data are necessary i.e. bone marrow assay for
chromosomal damage or a micronucleus test. In case this information is not provided, a
scientific justification should be submitted.
3.4.8.2 Such information on mutagenicity and genotoxicity should be provided for:
3.4.9 Toxicokinetics
Basic data on the toxicokinetics of Active Substances and other components of a
reparation as well as Relevant Chemicals should be included. Information on absorption,
distribution, metabolism and elimination (e.g. OECD guideline 417) should be presented,
if available, to allow better understanding of toxic effects and a reduction of animal
testing. The potential for dermal absorption should be evaluated preferably in vitro
or by physico-chemical data to reduce the need for any specific dermal toxicity
testing.
3.5 Data on environmental fate and effect under aerobic and anaerobic
conditions
This section describes the data on environmental fate and effect under aerobic and
anaerobic conditions specified in paragraph 4.2.1.3 of Procedure (G9).
3.5.1 General
3.5.1.1 The rate and route of abiotic and biotic degradation of the Active Substances,
components of a Preparation and Relevant Chemicals under aerobic and anaerobic
conditions should be assessed, resulting in the identification of relevant metabolites
in the relevant media (ballast water, marine and fresh waters) (G9: 5.3.4).
3.5.1.2 The solids-water partition coefficient (Kd) and/or organic carbon
normalized distribution coefficient (Koc) of the Active Substances,
components of a Preparation and Relevant Chemicals should be determined (G9: 5.3.6).
3.5.1.3 The data submitted in accordance with this paragraph should clarify, in addition
to the degradation of the substance, other relevant routes of dispersion in and from
water, such as volatilization, adsorption, sedimentation and transformation into bound
residues. Accordingly, the exposure of organisms living in water and the sediment should
be established.
3.5.2 Modes of degradation (biotic; abiotic)
3.5.2.1 Testing should include:
-
.1 a study on hydrolysis at pH 5, 7, and 9 under aerobic conditions according to
OECD guideline 111;
-
.2 a study on ready biodegradability according to OECD guideline 301 (Ready
Biodegradability) or equivalent guidelines if the Active Substance is discharged
only into fresh water;
-
.3 a study on ready biodegradability according to OECD guideline 306
(Biodegradability in Seawater) or equivalent guidelines if the Active Substance is
discharged only into marine water;
-
.4 studies on ready biodegradability according to OECD guideline 301 (or
equivalent guidelines) and OECD guideline 306 (or equivalent guidelines) if the
Active Substance is discharged into estuarine water (e.g. inland harbour with
contact to seawater); and
-
.5 evaluating the fate of Active Substances and Relevant Chemicals in fresh water
(PSU < 1), brackish water (PSU 10-20) and in marine water (PSU 28- 36) each in
a range of 0°C to 40°C (2°C to 40°C for fresh water) and a midrange temperature of
10°C to 20°C subject to an assessment verified by the Administration.
3.5.2.2 If the Active Substance is not readily biodegradable, then the following higher
Tier studies should be conducted:
-
.1 a study on aerobic and anaerobic transformation in aquatic
sediment systems according to OECD guideline 308 (Aerobic and Anaerobic
Transformation in Aquatic Sediment Systems) or equivalent guidelines if
Koc > 500 L/kg, using fresh or marine water depending on the kind
of aquatic ecosystem where discharge is intended. At least one system with high
organic matter/nutrient content and one with low organic matter/nutrient content
should be tested;
-
.2 a study on aerobic transformation of low concentrations of organic contaminants
according to OECD guideline 309 (Aerobic Mineralization in Surface Water –
Simulation Biodegradation Test) or equivalent guidelines, using fresh or marine
water depending on the kind of aquatic ecosystem where discharge is intended;
and
-
.3 where relevant, a study on photo-transformation in water, e.g. US EPA OPPTS
835.2210 (1998) and/or OECD Guidance document on photo-transformation in water
(1997).
3.5.2.3 Such information on the modes of degradation should be provided for:
-
.1 Active Substances;
-
.2 Other Chemicals; and
-
.3 Relevant Chemicals.
3.5.3 Persistence and identification of the main metabolites in the
relevant media (ballast water, marine and fresh waters)
3.5.3.1 The route of degradation in the higher Tier simulation tests specified under
section 3.5.2 of this Methodology should be characterized based on a mass balance,
including mineralization and formation of bound residues. Reaction or transformation
products formed that may be considered as Relevant Chemicals should be identified.
3.5.3.2 Such information on persistence and metabolites should be provided for:
-
.1 Active Substances;
-
.2 Other Chemicals; and
-
.3 Relevant Chemicals.
3.5.4 Bioaccumulation, partition coefficient, octanol/water partition
coefficient
3.5.4.1 Data should include:
-
.1 information on bioconcentration and biomagnification, which have already been
detailed earlier in this Methodology;
-
.2 a study into the log Pow according to OECD guideline 107 (Partition
Coefficient (n-octanol/water): Shake Flask Method), OECD guideline 117 (Partition
coefficient – n-octanol/water HPLC Method) or equivalent test guidelines. For very
hydrophobic compounds, a slow stirring method is appropriate (e.g. OECD 123
(Partition coefficient – Slow Stirring Method)); and
-
.3 the partition coefficient between solids and liquids should be determined, e.g.
according to EU Technical Guidance Document on Risk Assessment (2003) for at least
three inocula, including fresh water sediment, marine sediment, and particulate
matter (sludge) (OECD 106). If no measured data are available for a specific
adsorbing material, it is assumed that all adsorption can be related to the
organic matter of the medium, viz. standardization to Koc. This is only
valid for non-ionic substances. For ionic substances, the Kp values and
the test characteristics (% clay, CEC, % o.c., pH) should be reported.
3.5.4.2 Such information on bioaccumulation and partition coefficients should be
provided for:
-
.1 Active Substances;
-
.2 Other Chemicals; and
-
.3 Relevant Chemicals.
3.5.5 Bioavailability/biomagnification/bioconcentration
3.5.5.1 If log Pow > 3, testing of the bioaccumulation
potential should be considered taking into account the following points:
-
.1 one bioconcentration factor (BCF) determined in a bioconcentration
study (at two dosing levels) with fish (e.g. OECD 305) or bivalves. The BCF should
be based on ptake/elimination kinetics (k1/k2). The
half-life for elimination should be reported. Fat content in marine fish typically
ranges between 0.5 and 15% of the whole body weight. BCF should be normalized to
5% fat. The BCF, could e.g. be calculated with formulae 74 and 75 of the TGD (see
3.3.5) using the log Kow;
-
.2 the biomagnification and persistence in the food web should be
discussed based on the results from aquatic toxicity testing, mammalian toxicity
evaluation and bioaccumulation and biodegradation data; and
-
.3 there are no data provisions on bioavailability since it is
considered that the bioavailability in the toxicity test systems is equivalent to
the conditions under assessment. If the bioavailability of the Active Substance or
Relevant Chemical in the discharge or the receiving environment is to be assessed,
consequently, the bioavailability in the toxicity testing is to be
reconsidered.
3.5.5.2 Such information on bioavailability/biomagnification/bioconcentration should be
provided for:
-
.1 Active Substances;
-
.2 Other Chemicals; and
-
.3 Relevant Chemicals.
3.5.6 Reaction with organic matter
3.5.6.1 The reaction of radicals produced by the action of Active Substances with
organic matter should be addressed qualitatively as to identify products of concern to
the environment and, where possible, quantitatively as to identify environmental
concentrations. In cases where this information is not available, a scientific
justification should be submitted.
3.5.6.2 Radical producing chemicals are capable of forming halogenated (chlorinated,
brominated) hydrocarbons that may be of concern to environment or human health, in the
presence of organic matter. For these substances, the freely and otherwise reasonably
available information should be presented and discussed in relation to the proposed
manner of application, since they are subject to the decision making criteria.
3.5.6.3 Such information on the reaction with organic matter should be provided for:
3.5.7 Potential physical effects on wildlife and benthic habitats
3.5.7.1 Data requirements consisting of physical/chemical properties are also required
under other headings. Further guidance can be found in the MEPC-approved hazard
evaluation procedure published as GESAMP Reports and Studies No.64. In cases where this
information is not available, a scientific justification should be submitted.
3.5.7.2 Such data on the potential physical effects on wildlife and benthic habitats
should be provided for:
-
.1 Preparations including any of their components;
-
.2 Active Substances;
-
.3 Relevant Chemicals; and
-
.4 discharged ballast water.
3.5.8 Potential residues in seafood
3.5.8.1 As appropriate, data should be submitted to assess the potential presence of
residues of the Active Substance in seafood, the possible impact on consumer safety, and
the level of residues that may be tolerated in seafood. Any available monitoring data on
residues of the substance in seafood should be submitted.
3.5.8.2 Such data on potential residues in seafood should be provided for:
3.5.9 Any known interactive effects
3.5.9.1 Any knowledge (or absence of this knowledge) on interactive effects of the
substances identified with the ballast water, with other Preparations to be used in
ballast water, with other physical or chemical management of the ballast water, or with
the receiving environment, should be reported. In cases where this information is not
available, a scientific justification should be submitted.
3.5.9.2 Such information on known interactive effects should be provided for:
3.6 Physical and chemical properties for the Active Substances and
Preparations and treated ballast water, if applicable
This section describes the physical and chemical properties specified in paragraph
4.2.1.4 of Procedure (G9).
3.6.1 General
Data should be submitted for the Active Substances, Preparations including any of its
components, the treated ballast water on board and the Relevant Chemicals to allow for
the identification of hazards to the crew, the ship and the environment.
3.6.2 Melting point
Data on the melting point should be provided for Active Substances.
3.6.3 Boiling point
Data on the boiling point should be provided for Active Substances.
3.6.4 Flammability (flash point)
Data on the flash point should be provided for:
3.6.5 Density (relative density)
Data on the density should be provided for:
3.6.6 Vapour pressure, vapour density
Data on the vapour pressure and vapour density should be provided for:
3.6.7 Water solubility/dissociation constant
Data on the water solubility and dissociation constant should be provided for:
3.6.8 Oxidation/reduction potential
Data on the oxidation/reduction potentials should be provided for:
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.1 Preparations including any of their components;
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.2 Active Substances;
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.3 Relevant Chemicals; and
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.4 discharged ballast water.
3.6.9 Corrosivity and chemical influence on the materials or equipment of normal
ship construction
3.6.9.1 For the dataset, at least the corrosivity and chemical influence to low carbon
steel and other metals (e.g. stainless steel, Cu alloys and Ni alloys) and non-metals
(e.g. gasket, coatings and seal materials) as may be found in a ship's seawater piping,
fittings and structures that will be exposed to the Active Substance and Relevant
Chemicals should be provided.
Data required for Basic Approval
3.6.9.2 For Basic Approval it is sufficient that the data from publicly available
sources are submitted.
Data required for Final Approval
3.6.9.3 For Final Approval evaluation, the risk to the Safety of Ships should be
assessed (see chapter 7.1).
3.6.10 Auto-ignition temperature
Data on the auto-ignition temperature should be provided for:
3.6.11 Explosive properties
Data on the explosive properties should be provided for:
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.1 Active Substance; and
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.2 Relevant Chemicals.
3.6.12 Oxidizing properties
Data on the oxidizing properties should be provided for:
3.6.13 Surface tension
Data on the surface tension should be provided for:
3.6.14 Viscosity
Data on the viscosity should be provided for:
3.6.15 Thermal stability and identity of relevant breakdown products
Data on thermal stability and identity of relevant breakdown products should be provided
for Active Substances.
3.6.16 Reactivity towards materials
Data on the reactivity towards materials, e.g. piping, gaskets and containers, should be
provided for:
3.6.17 pH
Since the pH of test waters can influence the formation of disinfection by-products, all
chemical analysis results relating to the investigation of by-product formation should
be accompanied by a specification of the pH. Data on the pH should be provided for
uptake water and discharged water.
3.6.18 Salinity
Since the salinity of test waters can influence the formation of disinfection by
products, all chemical analysis results relating to the investigation of by-product
formation should be accompanied by a specification of the salinity. If water of
different sources was mixed or any additives were added to natural test water to achieve
the given salinity, this should be specified. Data on the salinity should be provided
for uptake water and discharged water.
3.6.19 TOC, DOC, percentage of particulate matter
Since the organic carbon and particulate matter content of test waters can influence the
formation of disinfection by-products, all chemical analysis results relating to the
investigation of by-product formation should be accompanied by a specification of TOC,
DOC, and total suspended solids (TSS). Data on the TOC, DOC and percentage of
particulate matter should be provided for uptake water and discharged water. If any
additives were added to natural test water, the information submitted under Procedure
(G9) should include all details regarding the selection and validation of additives as
specified in paragraph 2.4.21 of the annex to the 2016 Guidelines (G8). In particular,
any information on the results of measuring Specific UV Absorbance at 254 nm should be
provided.
3.6.20 Other known relevant physical or chemical hazards
Data on the any other known relevant physical or chemical hazards should be provided
for:
3.7 Analytical methods at environmentally relevant concentrations
This section describes the analytical methods at environmentally relevant
concentrations, stated in paragraphs 4.2.1.5 and 5.3.15 of Procedure (G9).
3.7.1 Recognizing that some methods may only cover a range of chemicals, e.g. TRO,
analytical methods at environmentally relevant concentrations should be provided
for:
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.1 Active Substance; and
-
.2 Relevant Chemicals.
3.7.2 If the BWMS needs any monitoring system for the Active Substance, the analytical
methods and product name of the monitoring equipment should be provided.