United States      Prevention, Pesticides     EPA712-C-08-007
         Environmental Protection    And Toxic Substances      October 2008
         Agency        (7101)
4>EPA   Fate, Transport and
         Transformation Test
         Guidelines

         OPPTS 835.3420
         Anaerobic
         Biodegradability of
         Organic Compounds in
         Digested  Sludge: By
         Measurement of Gas
         Production

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                            INTRODUCTION
      This guideline is one of a series of test guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances
(OPPTS), United States Environmental Protection Agency for use in the testing
of pesticides and toxic substances, and the development of test data to meet the
data requirements of the Agency under the Toxic Substances Control Act (TSCA)
(15 U.S.C. 2601), the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and
Cosmetic (FFDCA) (21 U.S.C. 346a).

      OPPTS developed this guideline through a process of harmonization of
the testing guidance and requirements that existed for the Office of Pollution
Prevention and Toxics (OPPT) in Title 40, Chapter I, Subchapter R of the Code
of Federal Regulations (CFR), the Office of Pesticide Programs (OPP) in
publications of the National Technical Information Service (NTIS) and in the
guidelines published  by the Organization for Economic Cooperation and
Development (OECD).

      For additional  information about OPPTS harmonized guidelines and to
access this and other guidelines, please go to http://www.epa.gov/oppts and
select "Test Methods & Guidelines" on the  left side menu.

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OPPTS 835.3420: Anaerobic biodegradability of organic compounds
in digested sludge: by measurement of gas production.

       (a) Scope—(1) Applicability. This guideline is intended for use in testing
pursuant to the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601).

       (2)  Background. This  OPPTS  test guideline is based  on the OECD
Guideline for the Testing of Chemicals no. 311, Anaerobic biodegradability  of
organic compounds  in  digested  sludge:  by measurement  of gas production,
(adopted    23    March    2006),    available   from   Source   OECD    at
http://masetto.sourceoecd.org/.

       (b) Purpose.  This  guideline  describes  a  screening  method  for the
evaluation of potential anaerobic biodegradability of organic chemicals in typical
anaerobic digesters. Sludge is  exposed to the test  substance for  up to  60  days,
which is longer than the normal sludge retention time (25 to 30 days) in anaerobic
digesters, though at industrial sites retention times may be much longer. Because
a diluted  sludge is used with a  relatively high concentration of test substance and
the duration of the test is longer than typical retention times, the conditions of the
test do not necessarily correspond to the conditions in real anaerobic digesters.
The  objective  is  to provide  a screening-level  indication of methanogenic
anaerobic biodegradation potential. No inferences about anaerobic biodegradation
with other electron acceptors (e.g. sulfate or nitrate) can be  made based on this
test. Moreover, the test is not necessarily applicable to other anoxic environmental
compartments even if methanogenic.

       (c) Overview—(1) Various proportions of water-insoluble chemicals,  as
well as of those that adsorb  onto sewage solids, are treated aerobically, since they
are present in settled sewage.  However, a large fraction of these  chemicals  is
bound  to the primary settled  sludge, which is separated from raw sewage  in
settlement tanks  before the  settled, or supernatant, sewage is treated aerobically.
The sludge, also containing some of the soluble compounds  in the interstitial
liquid,  is then passed to heated digesters for  anaerobic treatment. There  are a
number of  screening tests  for assessing  aerobic biodegradability of organic
chemicals (OECD Test Guidelines 301  A-F; 302 A-C; 303  A) (see paragraphs
(1)(1) and (1)(2)  of this guideline), and the results  of applying these have been
successfully  used  to predict  the fate  of chemicals  in  aerobic environments
including wastewater treatment. However, as yet there are no tests  in this series
for assessing biodegradability under  methanogenic  conditions in anaerobic
digesters. This test is targeted to fill this gap.

       (2) Respirometric techniques that measure the  amounts of gas produced,
mainly methane (CH/t) and carbon dioxide (CO2) under anaerobic conditions,
have been used successfully for assessing anaerobic biodegradability. Birch et al.

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(see paragraph (1)(3) of this guideline) reviewed these procedures and concluded
that the work of Shelton and Tiedje (see paragraph (1)(4) of this guideline), based
on earlier studies (see paragraphs (1)(5), (1)(6) and (1)(7) of this guideline), was the
most comprehensive. The method (see paragraph (1)(4) of this guideline), which
was further developed by others (see paragraph (1)(8) of this guideline) and has
become  the American  standard  (see paragraphs  (1)(9)  and  (1)(10)  of this
guideline),  did not resolve problems  related to the differing solubilities of CC>2
and CH4 in the  test medium  and  to the  calculation of  the theoretical  gas
production of a test substance. The ECETOC report (see paragraph (1)(3) of this
guideline) recommended the additional measurement of the  dissolved inorganic
carbon (DIG)  content of the supernatant liquid, which made  the technique more
widely  applicable. The ECETOC method  was subjected  to an international
calibration  exercise (or ring test) and became the ISO Standard, ISO 11734 (see
paragraph (1)(11) of this guideline).

       (3) Predictions from the results of this test cannot be made as convincingly
as they can be made in the case  of aerobic biodegradation. The evidence accrued
on  the behavior of test substances in ready aerobic tests and in simulation  tests
and the aerobic  environment  is  sufficient to  be  confident that there  is  a
connection,  but little similar evidence exists for the anaerobic  environment.
Complete anaerobic biodegradation can  be  assumed to occur  if 75%-80% of
theoretical  gas production is achieved. The  high ratios of chemical-to-biomass
used in these tests mean that a chemical that passes is more likely to be degraded
in an anaerobic digester. Additionally, substances that fail to  be converted to gas
in the test may not necessarily persist at more environmentally realistic substance-
to-biomass ratios. Also, other anaerobic reactions  occur by which substances may
be at least partially degraded, e.g.  by  dechlorination, but this test does not detect
such reactions. However, by applying specific analytical methods for determining
the  test substance, its disappearance (see  paragraph (j)(5) of this guideline) may
be monitored.

       (d) Principle  of the test.  (1) Washed digested sludge, containing low
(<10 mg/L) concentrations of inorganic carbon (1C), is diluted about ten-fold to a
total solids concentration  of 1 g/L to 3 g/L and incubated at 35 ± 2°C in sealed
vessels with the  test substance at 20 to 100 mg C/L for up to  60 days. Allowance
is made for measuring the activity of the sludge by running parallel blank controls
with sludge inoculum in the medium but without test substance. Digested  sludge is
a mixture of the settled phases  of sewage  and activated sludge, which have  been
incubated in an anaerobic digester  at about 35°C to reduce biomass and odor problems
and to improve the dewater-ability of the sludge. It consists of an association of anaerobic
fermentative and  methanogenic bacteria producing carbon  dioxide and methane (see
paragraph (1)(10)).

       (2) The increase in headspace pressure in the vessels resulting from the
production of carbon dioxide  and methane is  measured.  Much of the  CO2

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produced will be dissolved in the liquid phase or transformed into carbonate or
hydrogen  carbonate  under the conditions of the test. This inorganic  carbon is
measured at the end of the test.

       (3)  The amount of carbon (inorganic  plus  methane) resulting from  the
biodegradation of the test  substance is calculated from the net gas production and
net 1C formation in the liquid phase in excess of blank control values. The extent
of biodegradation is calculated  from total 1C  and methane-C  produced as a
percentage  of the  measured  or calculated  amount of carbon added  as test
substance. The course of biodegradation can be followed by taking intermediate
measurements of gas production only. Additionally the primary biodegradation
can be determined by specific analyses at the beginning and end of the test.

       (e) Information on the  test substance. The  purity,  water solubility,
volatility and adsorption characteristics of the test substance should be  known to
enable correct interpretation of results to be made. The organic carbon content (%
w/w) of the test substance needs to be known either from its chemical structure or
by measurement. For volatile  test substances, a measured or calculated  Henry's
law constant is helpful in  deciding whether the test  is applicable. Information on
the toxicity of the test substance to anaerobic bacteria  is useful in  selecting an
appropriate test substance  concentration, and for interpreting results showing poor
biodegradability.  It is recommended to include the inhibition control unless it is
known that the test substance  is not inhibitory to anaerobic microbial  activities:
see paragraph (i)(9) of this guideline and ISO 13641-1 (paragraph (1)(12) of this
guideline).

       (f) Applicability of the method. The test may be applied to water-soluble
chemicals; it  may also be applied to poorly soluble and insoluble chemicals,
provided that  a method of exact  dosing  is used (e.g. see ISO 10634; paragraph
(1)(13) of this guideline). In general, a case-by-case decision is necessary  for
volatile substances. Special steps may have to be taken, for example, to  avoid
releasing gas during the test.

       (g) Reference substances. To check the procedure, a reference  substance
is tested by setting up appropriate vessels in parallel as part of normal test runs.
Phenol, sodium benzoate and polyethylene glycol 400 are examples and would be
expected to be  degraded by  more than 60%  theoretical gas  production (i.e.
methane and inorganic carbon) within 60 days  (see paragraphs (1)(3) and (1)(14)
of this guideline).

       (h) Reproducibility of test results. (1) In an international ring test (see
paragraph (1)(15) of this guideline) there was good reproducibility in gas pressure
measurements  between   triplicate   vessels.  The  relative   standard  deviation
(coefficient of variation, COV) was mainly below 20%,  although this value often
increased to >20% in the presence of toxic chemicals or towards the end of the 60

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d incubation period. Higher deviations were also found in vessels of volume <150
ml. Final pH values of the test media were in the range 6.5-7.0.
             Table 1. Ring test results for two test substances.

Test
Substance

Palmitic acid
Polyethylene
Glycol 400

Total
data

36
38


Mean
degradation
(for all data)

68.7 ±30.7
79.8 ±28.0

Relative
Standard
deviation
(for all
data)
fO/\
(/o)
45
35


Valid
data
n2

27
29


Mean
degradation
(of valid
data) (%)

72.2 ±18.8
77.7 ±17.8


Standard
deviation
(of valid
data) (%)

26
23


Data>60%
degradation
in valid
tests n3

19 = 70%*
24 = 83 %*

* Proportion of n2

       (2) Table 1 presents ring test results for two substances. The coefficients
of variation  of the mean  for  all  values  obtained  with  palmitic acid  and
polyethylene  glycol 400 were as high  as  45%  (n  = 36) and  35% (n = 38),
respectively. When values of <40% and >100% were omitted (the former being
assumed to be due to suboptimal conditions, the latter due to unknown reasons),
the COVs were reduced to 26% and 23%, respectively. The proportions of valid
values attaining at least 60% degradation were 70% for palmitic acid and 83% for
polyethylene  glycol  400. The proportions  of the percentage biodegradation
derived from DIG measurements were relatively low but variable. For  palmitic
acid   the  range  was  0-35%, mean   12%, with  COV  of  92%;  and  for
polyethyleneglycol 400 the range was 0-40%, mean 24%, with COV of 54%.

       (i) Description  of the  test  method—(1)  Apparatus, (i)  The usual
laboratory equipment and that  listed in paragraphs (i)(l)(ii) through (i)(l)(iv) of
this guideline are used:

       (ii) Incubator - spark-proof and controlled at 35°C ± 2°C;

       (iii) Pressure-resistant glass test vessels of an appropriate nominal size,
each  fitted with  a gaslight septum, capable of withstanding about 2 bar of
pressure. The recommended size is 0.1 liter to  1 liter. The headspace volume should
be about 10% to 30% of the total volume. If biogas is released regularly, about
10% headspace volume is appropriate, but if the gas release is made only at the
end of the test 30% is  appropriate. Glass serum bottles, of nominal volume  125
ml, total volume  ca. 160 ml,  sealed with serum septa and  crimped aluminum
rings, are recommended when the pressure is released at each sampling time. The
use of gas-tight silicone septa is recommended. It is further recommended that the gas-
tightness of caps, especially butyl rubber septa, be tested, because several commercially

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available septa are not sufficiently gas-tight against methane and some septa do not stay
tight when they are pierced with a needle under the conditions of the test.

       (iv)  Pressure-measuring device  adapted to  enable  measurement  and
venting of the gas produced; for example, a hand-held precision pressure meter
connected to a suitable syringe needle. A 3-way gas-tight valve facilitates the
release  of excess pressure (see Figure 1). It is necessary to keep the internal
volume of the pressure transducer tubing and valve as low as possible, so that
errors introduced by neglecting the volume of the equipment are insignificant.

Figure 1. Example of an apparatus to measure biogas production by gas
pressure
                                           Pressure
                                             meter
            \xvs
 3-way gas-tight valve

Syringe needle

        Gaslight seal (crimp cap and septum)

                                 Head space
                                 Digested sludge inoculum (Vf)
              (test vessels in an environment of 35°C ± 2°C)

       (A) The device  should be  used  and calibrated  at  regular  intervals,

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according to the manufacturer's instructions. If a pressure meter of the prescribed
quality is used (e.g. capsulated with a steel membrane), no calibration is necessary
in the laboratory. The accuracy of the calibration can be checked at the laboratory
with a measurement at 1 x 105 Pa  against a pressure meter with  a  mechanical
display. When this point is measured correctly, the linearity will also be unaltered.
If other measurement  devices  are  used  (without  certified calibration  by the
manufacturer),  calibration is recommended over  the  total  range  at  regular
intervals.

       (B) The pressure  readings are used  directly to calculate the amount of
carbon produced in the headspace (see paragraphs (k)(l)(i), (k)(2)(i) and (k)(2)(ii)
of this  guideline).  Alternatively, the pressure readings may be  converted to
volumes (at 35°C,  atmospheric pressure)  of gas produced using  a  conversion
graph. This graph is constructed from data obtained by injecting known volumes
of nitrogen gas into a series of test vessels  (e.g. serum bottles) at 35° +/-2°C, and
recording the resulting stabilized pressure readings, as shown below in paragraph
(i)(2) of  this  guideline.  The calculation  is  shown  in  the  Note  in paragraph
(k)(2)(ii) of this guideline.

       (v) Carbon  analyzer,  suitable for the direct determination of inorganic
carbon in the range  of 1 mg/L to 200 mg/L;

       (vi) Syringes of high precision for gaseous and liquid samples;

       (vii) Magnetic stirrers and followers (optional);

       (viii) Glove box (recommended).

       (2) Conversion of the pressure meter. The pressure meter readings may
be related to gas volumes by means of a  standard curve produced by injecting
known volumes of air at 35°C ± 2°C into  serum bottles containing a volume of
water equal to that  of the reaction mixture, PR, as in paragraphs (i)(2)(i) through
(i)(2)(viii) of this guideline:

       (i) Dispense PR mL aliquots of water, kept at 35°C ± 2°C, into five serum
bottles.  Seal the bottles and place in a water bath at 35°C for 1 hour to equilibrate;

       (ii) Switch on the pressure meter, allow to stabilize, and adjust to zero;

       (iii) Insert the syringe needle through the  seal of one  of the bottles,  open
the valve until the pressure meter reads zero and close the valve;
       (iv) Repeat the procedure with the remaining bottles;

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       (v) Inject 1 mL of air at 35°C ± 2°C into each bottle. Insert the needle (on
the meter) through the seal of one of the bottles and allow the pressure reading to
stabilize. Record the pressure, open the valve until the pressure reads zero and then
close the valve;

       (vi) Repeat the procedure for the remaining bottles;

       (vii) Repeat the  total procedure  above (see paragraphs (i)(2)(i)  through
(i)(2)(vi) of this guideline) using 2 mL, 3 mL, 4 mL, 5 mL, 6 mL, 8  mL, 10 mL,
12 mL, 16 mL, 20 mL and 50 mL of air;

       (viii) Plot  a  conversion  curve of pressure (Pa) against volume of air
injected (mL). The response of the instrument is linear over the range 0 Pa to 70
000 Pa, and 0 mL to 50 mL of gas production.

       (3) Reagents. Use analytical  grade reagents throughout.

       (4) Water. Distilled or deionized water (deoxygenated by  sparging with
nitrogen gas containing  less than 5  |iL/L oxygen), containing less than 2 mg/L
DOC.
       (5)  Test medium, (i) Prepare the dilution  medium  to contain the
constituents in this paragraph at the stated amounts:

       Anhydrous potassium dihydrogen phosphate (KH2PO4)	0.27 g
       Disodium hydrogen phosphate dodecahydrate ... (Na2HPO4.12H2O) 1.12 g
       Ammonium chloride (NH^C!)	0.53 g
       Calcium chloride dihydrate (CaCl2.2H2O) 	0.075g
       Magnesium chloride hexahydrate 	(MgCl2.6H2O) 0.10 g
       Iron (II) chloride tetrahydrate 	(FeCl2.4H2O) 0.02 g
       Resazurin (oxygen indicator)	O.OOlg
       Sodium sulfide nonahydrate (Na2S.9H2O) 	0.10 g
       Stock solution of trace elements	(optional, see paragraph (i)(6)) 10 ml
       Add deoxygenated water	(see paragraph (i)(4)) to 1 liter

       Freshly supplied  sodium sulfide should be used or it should be washed and
dried before use,  to ensure  sufficient  reductive  capacity.  The test may be
performed  without using  a glove box.  In  this case, the final concentration of
sodium sulfide in the medium should be increased to 0.20 g of Na2S.9H2O per
liter. Sodium  sulfide may also be  added from an appropriate anaerobic stock
solution (prepared  in deoxygenated  water; see  paragraph (i)(4) of this guideline)
through the septum of the closed test vessels as this procedure will decrease the
risk of oxidation.  Sodium sulphide may be replaced by  titanium  (III) citrate,
which is added through  the septum  of closed test vessels at a final concentration
of 0.8 to 1.0 mmol/L. Titanium (III) citrate is a highly effective and  low-toxicity

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reducing agent, which is prepared as follows: Dissolve 2.94 g of trisodium citrate
dihydrate in 50 ml of deoxygenated water (to result in a solution of 200 mmol/L)
and add 5 ml of a 15% (w/v) titanium (III) chloride solution. Neutralize to pH 7 ±
0.2 with mineral alkali and dispense to an appropriate vessel under a stream of
nitrogen. The concentration of titanium (III) citrate in this stock solution is  164
mmol/L.

       (ii)  Mix the components of the test medium except the  reducing agent
(sodium  sulfide or titanium citrate) and sparge the solution with nitrogen gas for
about 20 min immediately before use to remove oxygen. Then add the appropriate
volume of  freshly  prepared solution of the reducing agent just before use of the
medium. Adjust the pH of the medium, if necessary, with dilute mineral acid or
alkali to 7 ± 0.2.

       (6)  Stock solution of trace elements (optional). It is  recommended that
the test medium should contain the trace elements in this paragraph to improve
anaerobic degradation processes,  especially if low concentrations (e.g. Ig/L) of
inoculum are used  (see paragraph (1)(11) of this guideline).

       Manganese chloride tetrahydrate (MnCl2.4H2O)	50 mg
       Boric acid(H3BO3) 	5 mg
       Zinc chloride (ZnCb)	5 mg
       Copper (II) chloride (CuC^)	3 mg
       Disodium molybdate dihydrate (Na2MoO4.2H2O)	1 mg
       Cobalt chloride hexahydrate (CoCl2.6H2O)	100 mg
       Nickel chloride hexahydrate (NiCl2.6H2O) 	10 mg
       Disodium selenite (Na2SeC>3)	5 mg
       Add deoxygenated water (see paragraph (i)(4))	to 1 liter

       (7) Test substance. Add the test substance as a stock solution, suspension,
emulsion, or directly as solid or liquid, or absorbed onto glass-fiber filter, to give
a concentration of no more than 100 mg/L as  organic carbon. If stock solutions
are used, prepare a suitable solution in water prepared as in paragraph (i)(4) of
such a strength that the  volume  added is less than  5% of the total  volume of
reaction mixture. Adjust the pH of the stock solution to pH 7  ± 0.2 if necessary.
For test substances that are insufficiently soluble in water, consult ISO 10634 (see
paragraph (1)(13) of this guideline). If a solvent is used, prepare an  additional
control, with the solvent  only added to the inoculated medium. Organic solvents
that are  known to inhibit methane  production, such as chloroform and  carbon
tetrachloride, should be avoided.

       (8)  Reference substance. Reference substances such as sodium benzoate,
phenol and polyethylene glycol 400 have been used successfully to  check the
procedure,  being biodegraded by more than 60% within 60 days. Prepare a stock
solution  (in deoxygenated water; see paragraph (i)(4) of this guideline) of the

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chosen reference substance in the same way as for the test substance and adjust to
pH 7 ± 0.2 if necessary.

       (9) Inhibition control (conditional). In order to obtain information on the
toxicity of the test substance to anaerobic microorganisms in order to find the
most  appropriate  test substance  concentration, add  the test substance  and
reference substance to a vessel containing the test medium: see paragraph (i)(5)(i)
of this guideline); also ISO 13641-1 (paragraph (1)(12) of this guideline).

       (10) Digested  sludge, (i) Collect digested sludge from a digester at a
wastewater treatment  plant which treats predominantly  domestic sewage.  The
sludge should be fully characterized and its background information should be
reported (see paragraph (k)(9)(i) of this guideline). If use of adapted inoculum is
intended, digested  sludge from an industrial sewage treatment plant may be
considered. Use wide-necked bottles constructed from high-density polyethylene
or a similar material, which can expand, for the collection of the digested  sludge.
Add sludge to within about 1  cm of the top of the bottles and seal  tightly,
preferably with a  safety  valve. After transport to the laboratory, the collected
sludge may be  used directly or placed in a laboratory-scale digester.  Release
excess biogas by opening bottles of sludge carefully. Alternatively, laboratory-
grown anaerobic sludge may be used as a source of inoculum;  but its spectrum of
activity may be lower.

       (ii) In order to reduce background gas production and to decrease the
influence of the blank controls,  predigestion of the sludge may be  considered. If
predigestion is  required,  the sludge should be  allowed to digest without the
addition of any nutrients or substrates at 35°C ± 2°C for up to  7 days. It has been
found  that predigestion for about 5 days usually gives an optimal decrease in gas
production of the blank without unacceptable increases in either lag or incubation
periods during the test phase, or  loss of activity.

       (iii) For  test  substances  that  are,  or are  expected  to  be,  poorly
biodegradable,  consider preexposure of the sludge to the test substance to obtain
an inoculum that is better adapted.  In such a case, add the test substance at an
organic carbon concentration of 5 to 20 mg/L to the digested sludge and incubate
for up to 2 weeks.  Wash  the pre-exposed  sludge carefully  before use (see
paragraph (i)(l 1) of this guideline) and indicate in the test report the conditions of
the preexposure.

       (11) Inoculum. Wash the sludge (see  paragraph (i)(10) of this guideline)
just prior to use, to reduce the 1C concentration to less than 10 mg/L in the final
test suspension. Centrifuge the  sludge  in sealed tubes (e.g. 3,000 x g during 5
min) and discharge the supernatant.  Suspend the resulting pellet in  deoxygenated
medium (see paragraph (i)(5) of this guideline), re-centrifuge the suspension and
discharge the supernatant liquid. If the  1C has  not been sufficiently lowered, the

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washing procedure of the sludge can be repeated up to two times. This does not
appear to  affect the microorganisms adversely. Finally, suspend the pellet in the
requisite volume  of test medium and  determine the concentration of total solids
(e.g. see ISO 11923; paragraph (1)(15) of this guideline). The final concentration
of total  solids in the test vessels should be in the range of 1  g/L to 3 g/L (or about
10% of that in undiluted digested sludge). Inoculum should be prepared in such a
way that  the sludge has  minimal contact with oxygen  (e.g. use  a nitrogen
atmosphere).

       (j)  Test procedure—(1)  General. Perform  the  initial procedures  in
paragraphs (j)(2) and (j)(3) of this  guideline using techniques to keep the contact
between digested sludge and oxygen as low as practicable; for example, it may be
necessary  to work within a glove box in an atmosphere of  nitrogen and/or purge
the  bottles with nitrogen (see paragraph (1)(4) of this guideline).

       (2) Preparation of test and control assays, (i) Prepare at least triplicate
test vessels (see paragraph (i)(l)(ii) of this guideline) for the test substance, blank
controls,  reference  substance, inhibition  controls  (conditional) and pressure
control  chambers (optional procedure).  Additional  vessels for the purpose  of
evaluating primary biodegradation using test substance-specific analyses may also
be  prepared. The same set of blank  controls  may  be used  for  several test
substances in the same test as long as the headspace volumes are consistent.

       (ii) Prepare the diluted inoculum before  adding it to  the vessels e.g. by the
means of a wide-mouthed pipette. Add aliquots of well-mixed inoculum  (see
paragraph (i)(ll) of this guideline) so that the concentration of total solids is the
same in all  vessels (between  1 and 3 g/L). Add stock solutions of the test and
reference substance after adjustment to pH 7 ± 0.2 if necessary. The test substance
and the reference substance should be added using the most appropriate route of
administration (see paragraph (i)(7) of this guideline).

       (iii) The concentration of test substance as organic carbon should normally
be between  20  and 100 mg/L (see paragraph (d)(l) of this guideline).  If the test
substance  is toxic, the test concentration should be reduced to 20 mg C/L, or even
less if only  primary  biodegradation with specific analyses  is to be measured. It
should  be noted  that the variability  of the test results increases  at lower test
concentrations.

       (iv) For blank vessels, add an equivalent amount of the carrier used to
dose the test substance instead of a stock solution, suspension or emulsion. If the
test substance was administered using glass fiber filters  or organic solvents, add to
the  blanks a filter or an  equivalent volume solvent that  has  been evaporated.
Prepare an  extra replicate with test substance for the measurement of the  pH
value. Adjust the pH to 7 ± 0.2, if necessary, with small amounts of dilute mineral
acid or alkali. The same amounts of neutralizing agents should be added to all the
                                   10

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test vessels. These additions should not have to be made since the pH value of the
stock solutions of the test substance and reference substance have already been
adjusted (see  paragraphs  (i)(7)  and  (i)(8)  of this  guideline).  If primary
biodegradation is to be measured, an appropriate sample should be taken from the
pH-control  vessel, or from an additional  test vessel,  and the test  substance
concentration should be measured using specific analyses. Covered magnets may
be added to all the vessels if the reaction mixtures are to be stirred (optional).

       (v) Ensure that the total volume of liquid Vi and the volume of headspace
Vh are the same  in all vessels; note and record the values of Vi and Vh. Each
vessel should be sealed with a gas septum and transferred from the glove box into
the incubator.

       (3)  Insoluble test substances. Add  weighed amounts of substances that
are poorly  soluble in water directly to the prepared vessels. When the use of a
solvent  is necessary, transfer the test substance solution or  suspension into the
empty vessels. Where possible, evaporate the solvent by passing nitrogen gas
through the vessels and then add the other ingredients namely diluted sludge and
deoxygenated  water, as required.  An additional solvent control should also  be
prepared.  For other methods of adding insoluble substances,  ISO 10634  (see
paragraph (1)(13) of this guideline) can be consulted. Liquid test substances may
be dosed with a  syringe into the  completely prepared sealed  vessels, if  it is
expected that the initial pH will not exceed 7 ± 1;  otherwise dose as described in
paragraph (i)(7) of this guideline).

       (4)   Incubation and  gas pressure measurements, (i) Incubate  the
prepared vessels at 35°C ± 2°C for about 1  hr to allow equilibration and release
excess gas  to the atmosphere; for  example, by  shaking each vessel in turn,
inserting the  needle  of the  pressure meter (see paragraph (i)(l)(iii) of this
guideline) through the seal and opening the valve until the pressure meter reads
zero.  If at this stage, or when making intermediate measurements, the headspace
pressure is less than atmospheric, nitrogen gas should be introduced to reestablish
atmospheric pressure.  Close  the valve and continue to incubate in  the dark,
ensuring that all parts of the vessels are maintained at the digestion temperature.
Observe the vessels after incubation for 24 to 48h. Reject vessels if the contents
of the vessels show a distinct pink coloration in the supernatant liquid, i.e. if
resazurin  has  changed color indicating the presence of oxygen.  While small
amounts of oxygen may be tolerated by the system,  higher concentrations can
seriously inhibit  the course of anaerobic biodegradation.  The  rejection  of the
occasional  single vessel of a set of triplicates may  be accepted, but the incidence
of more failures  than  this should lead to  an investigation of the experimental
procedures and possibly repeating the test.

       (ii)  Carefully mix the contents of each vessel by stirring or by shaking for
a few minutes at least 2 or 3 times per week and  soon  before  each pressure
                                   11

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measurement. Shaking resuspends the inoculum and ensures gaseous equilibrium.
All pressure measurements should be taken quickly,  since the test vessels could
be subject to lowering of temperature, leading to false readings. While measuring
pressure the whole test vessel including the headspace should be maintained at the
digestion temperature. Measure the gas pressure, for example by inserting through
the septum the  syringe  needle (see  paragraph  (i)(l)(iii)  of  this guideline)
connected to the pressure-monitoring meter. Care should be taken to prevent entry
of water into the syringe needle;  if this occurs the wet parts should be dried and a
new needle fitted. The pressure should be measured in millibars. The gas pressure
in the vessels may be measured periodically, e.g. weekly, and (optionally) the
excess gas released to the atmosphere. Alternatively,  the pressure  is measured
only at the end of the test to determine the amount of biogas produced.

       (iii) It is recommended  that intermediate readings of gas pressure be made,
since pressure increase provides  guidance as to when the test may be terminated
and allows the kinetics to be followed.

       (iv) Normally  the test  should be ended after  an incubation period of 60
days unless the biodegradation curve obtained from  the  pressure measurements
has reached the plateau phase before then; that is, the phase in  which the maximal
degradation has been reached and the biodegradation  curve has leveled out. If the
plateau value is less than 60%, interpretation is problematic because it indicates
that only part of the  molecule has been mineralized or  that an error has been
made. If at the end of the  normal incubation period, gas is being produced but a
plateau phase obviously has not been reached, then prolonging the test should be
considered.

       (5) Measurement of inorganic carbon, (i) At the  end  of the test, after the
last measurement of gas pressure, allow the sludge to settle. Open each vessel in
turn and immediately take a sample for the  determination of the concentration
(mg/L) of inorganic carbon (1C)  in the  supernatant liquor. Neither centrifugation
nor filtration should be applied to the supernatant liquor, since there would be an
unacceptable  loss of dissolved carbon dioxide. If the liquor cannot be analyzed
immediately after sampling, store it in a sealed vial without headspace and cooled
to about 4°C for up to 2 days.  After the 1C measurement,  measure and record the
pH value.

       (ii) Alternatively, the 1C  in the supernatant may be determined indirectly
by release  of the dissolved 1C as carbon dioxide that can be measured  in the
headspace. Following the last measurement of gas pressure, adjust the pressure in
each of the test vessels to atmospheric pressure.  Acidify the contents  of each
vessel to approximately pH 1  by adding  concentrated mineral acid (e.g. H2SO4)
through the septum of the sealed vessels. Incubate the  shaken vessels at 35°C ±
2°C for approximately 24  hours  and measure the gas pressure resulting from the
evolved carbon dioxide by using the pressure meter.
                                   12

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       (iii)  Make  similar  readings  for the  corresponding  blank, reference
substance and, if included, inhibition control vessels.

       (iv) In some cases,  especially if the  same control vessels are used for
several test  substances, measurements of intermediate 1C concentrations in test
and control vessels should be considered, as appropriate. In this case, a sufficient
number of vessels should be prepared for all the intermediate measurements. This
approach is  preferred to taking all samples from a single vessel. The latter can
only be done if the volume needed for DIG analysis is not deemed to be too high.
The DIG measurement should be made after measuring the gas pressure without
release  of  excess  gas,  as  described  in  paragraphs  (j)(5)(iv)(A)  through
(j)(5)(iv)(D) of this guideline:

       (A) Using a syringe,  remove as small a volume as possible of supernatant
through the  septum, without opening the vessels, and determine the 1C  in the
sample;

       (B)  After having taken the  sample the excess gas may  or may not be
released;

       (C)  It should be taken into account that even a  small  decrease  in the
supernatant  volume (e.g. about  1%) can yield a  significant  increase in the
headspace gas volume (Vh);

       (D) Correct the equations (in paragraph (k)(2)(ii) of this guideline) by
increasing Vh in equation 3, as necessary.

       (6)  Specific  analyses.  If  primary  anaerobic  degradation  is  to  be
determined,  take  an appropriate volume of sample for specific  analyses  at the
beginning and at the end of the test from the vessels containing the test substance.
If this is  done, note the volumes of headspace (Vh) and of the liquid (Vi) will be
changed and take this into account when calculating the results of gas production.
Alternatively samples  may  be taken for specific  analyses from additional  test
mixtures previously set up for the purpose.

       (k) Data and Reporting—(1) Treatment of  results, (i) For practical
reasons, the pressure of the gas is measured in millibars (1 mbar = Ih Pa = 102 Pa;
1 Pa = 1 N/m2), the volume in liters and temperature in degrees Celsius.

       (ii) Figures  2 and 3  show sample  data  sheets that may be helpful for
recording measurements and facilitating calculations.
                                   13

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Figure 2. Example of data sheet for the anaerobic bio degradation test - data sheet for the test substance
Laboratory: 	       Test substrate:
Tcsttcnpcralwc:(°C)
Caibon in test substance Cfn-	.(mefl-) m,1:	
Test No.:	
Volume of liquid (Vs):.,. .(liters)
Day









1C (end)
pH (end)
Pi (i«t)
(rabar)








QC.I
test
(rag)


ft (t«t)
(mbar)








Qc.J
test
(rag)


jjj{(esrt)
(mtwr)








Q;»
test
(rat)


p (test)
mean
(rabar)








CK
test rawn
(rag)


ft
(Wank)
(mhar)








C*K;«
Wank
Cm)


Ps P<
(Wank) (blank)
(mbar) (mbar)








Cits Qc.ii
blank blank
tn>8) . Irai)


p (blank)
mean
(ratoar)








CK
blank
mean
(«««>


/>{aet)
test - Wank
mean
(mbar)








C*K-,B«
test -blank
mean
(rag)


4? (net)
cumulative
(mbar)








mt
liquid C^
(rag)


"h
bcadspacc
C
(ma)








«(
total Cs
(rag)


A,
Biodegrad
atiou1
(%)








A
Biodcpad
ation6
(%)


   1 Carton in test vessel, *¥{rag): m, =
   2 Carbon in headspace, 1% (mg) at normal incubation temperature (35 °C): mi, - 0,468ApxVb
   3 Biodegradalion calculated from headspaee gas, D\, (%): j
   4 Carbon in liquid, Bi^mg): mt = Cj^rtXV]
   5 Total gasified carbon, ou (mg): tck + wn
   s Total biodegratMen, D^ (%): D, - (ia,x 100) / FJ^.

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Figure 3. Example of data sheet for the anaerobic bio degradation test - data sheet for the reference substance
     Laboratory:	      Reference substance:...,	,	    Test No,:	
     Test iernpeimtun^fC)        Vaiurac of headspacc (Pj:___(L)    Volume of liquid (V,):... (liters)
     Cartxm in reference subataaoe Ceft',,. .(mgC) mt.7;	(mg)
Day









TC (cad)
pH(ei>d)
Pi (n£)
(jrtw)








Qe, L
rcf.
(i>«)


ft (ret)
(rabar)








Cie,2
rcf.
(rag)


/»j(nsf.)
(irtwr)

P(«r.)
mean
(nsbar)








Cfcj
rcf.
(rag)








cx.
tcf.mean
(rag)


jf4
(inbib.)
(mbar)

ft
(inhib.)
(robai)

!
|
\
1
1
:|
:|
Cic,4
tohJb.
(rag)
Qc,5
inhib.
(™«)
!
5
PIS
(inbib.)
(rabar)








CjC.d
inhib,
(rag)


p(iahib.)
mean
(rabar)








Ac
inhib.
meaa
(mg)


p(«f.) j 4K«f.)
reT - blank I cumulative
| (mbar)
(mbar) j








Cr.nfl 1 "*)
ret- inbib, j liquid Cw
(m) I (m)


m* A
ticatoacc Biodcgrad
C* alioii9
(rag) (%)








A
(ottIC Biodcgra4
alion11
(rag) . (%)


        ' Cwbon in test vessel, «v(mg); m^ =
        * Carbon k headspace, wh (m|J M nonm] incubaiiMi temperature (35 T)": 04 - 0.46&&pxVh
        9 Bi«tegnwlMi(M caJculaled frem headspace gas, D\, (%}: £H, • (mj,xlOO) / m,,
        ls Carbon in liquW, j»j( (nig}: »i|
        11 Total gasified carbon, m, (mg):
        11 Total biodegraduion, Dt {%): D, - (n^x 106) /

-------
       (2) Carbon  in the headspace.  (i) Since  1  mol of methane and 1  mol
carbon dioxide each contain 12 g of carbon, the mass of carbon in a given volume
of evolved gas may be expressed as:

             m = 12 x 103 x n            Equation [1]

where:
        m = mass of carbon (mg) in a given volume  of evolved gas;
        12 = relative atomic mass of carbon;
        n = number of moles of gas in the given volume.

If a gas other than methane or carbon  dioxide  (e.g.  N2O)  is  generated in
considerable amounts, the formula [1] should be amended in order to describe the
possibility of effects by gases generated.

(ii) From the gas laws n may be expressed as:

             pV
         n = —-                       Equation  [2]
             Kl

where:
        p = pressure of the gas (Pascals);
        V = volume of the gas (m3);
        R = molar gas constant [8.314J/(mol K)];
        T= incubation temperature (degrees Kelvin).

By  combination of equations [1] and [2]  and  rationalizing to  allow  for blank
             control production of gas:

              1    x 0. l(Ap • K)          Equation [3 ]
         BZi =	—
                    RT

where:
        nih = mass of net carbon produced as gas in the headspace (mg);
        A/> = mean of the difference between initial and final  pressures in the
        test  vessels  minus  the corresponding  mean  in  the blank  vessels
        (millibars);
        Vh = volume of headspace in the vessel (L);
        0.1 = conversion for both newtons/m2 to millibars and m3 to liters.

Equation [4] should be used for the normal incubation temperature of 35°C  (308
        K):
             mh = 0.468 (A/? x Vh)              Equation [4]
                                  16

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       Alternative volume calculation. Pressure meter readings are converted to
       mL of gas  produced using the standard curve generated by plotting
       volume (mL) injected versus meter reading (see paragraph (i)(2) of this
       guideline). The number of moles (n) of gas in the headspace of each vessel
       is calculated by dividing the cumulative gas production (ml)  by 25,286
       ml/mole,  which is the volume occupied by one mole of gas at 35°C and
       standard atmospheric pressure. Since 1 mole of CH4 and 1 mole of CC>2
       each contain 12  g of carbon, the amount of carbon (m, in mg) in the
       headspace (mh) is given by Equation [5]:

             nih = 12 x 103                     Equation [5]
       Rationalizing to allow for blank control production of gas:


                 12QQQ>Ar = o 475AF         Equation [6]
                    25286

where:
        mh = mass of net carbon produced as gas in the headspace (mg);
        AF = mean  of the difference between  volume  of gas produced  in
        headspace in the test vessel and blank control vessels;
        25286 = volume occupied by 1  mole gas at 35°C, 1 atmosphere.

       (iii) The course  of biodegradation  can be  followed by  plotting the
cumulated pressure increase A/? (millibars) against time, if appropriate. From this
curve, identify and record the lag phase  (days). The lag phase  is the time from the
start of the test until significant degradation starts (for example, see Figure 4). If
intermediate samples  of supernatant were  taken  and analyzed (see paragraph
(j)(5)(iv) of this guideline), then the total C produced (in gas plus that in liquid)
may be plotted instead of only the cumulative pressure.
                                  17

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   Figure 4.  Example  of a degradation  curve (cumulative net pressure
   increase)
          500 -
              0        10       20       30       40
                                       Time (days)
                                                    50
                                      60
       (3) Carbon in the liquid. The amount of methane in the liquid is ignored
since its solubility in water is known to  be  very low.  Calculate the mass  of
inorganic carbon in the liquid of the test vessels using equation [7]:
        mi = Cnet X V,
                         Equation [7]
where:
   mi = mass of inorganic carbon in the liquid (mg);
   Cnet = concentration of inorganic carbon in the test vessels minus that in the
   control vessels at the end of the test (mg/L);

       Vi =volume of liquid in the vessel (L).

       (4) Total gasified carbon. Calculate the total mass of gasified carbon in
the vessel using equation [8]:
mt =
                 mi
Equation [8]
                                  18

-------
where:
   mt = total mass of gasified carbon (mg);
   nih and mi are as defined in this paragraph.

       (5) Carbon of test substance. Calculate the mass of carbon in the test
vessels derived from the added test substance using equation [9]:

        mv = Ccx Vi             Equation [9]

where:
   mv= mass of test substance carbon (mg);
   Cc = concentration of test substance carbon in the test vessel liquid (mg/L)
   Vi= volume of liquid in the test vessel (L).

       (6) Extent of biodegradation. (i) Calculate the percentage biodegradation
from headspace gas using equation  [10] and the total percentage biodegradation
(i.e. determined from total gasified carbon) using equation [11]:

        Dh = (mh I mv ) x 100        Equation [10]
        A = (mt I mv ) x 100         Equation [11]

where:
   Dh = biodegradation  determined from headspace gas (%);
   A = total biodegradation (%);
   nih, mv and mt are as defined in this paragraph.

       (ii) The degree of primary biodegradation is calculated from the (optional)
measurements of the concentration of the test substance at the beginning and end
of incubation, using equation [12]:

        Dp  = (1 - Se I Si) x 100                  Equation  [12]

where:
   Dp = primary degradation of test substance (%);
   Sj = initial concentration of test substance (mg/L);
   Se = concentration of test substance at end (mg/L).

       (iii) If the method of  analysis  indicates significant concentrations of the
test substance in the unamended anaerobic sludge inoculum, use equation [13]:
        Dp = - [ 1 - (Se - Seb) / (Si - Sib) x 100     Equation [13]
where:
                                   19

-------
   Dp = corrected primary degradation of test substance (%);
   Sib = initial 'apparent'  concentration  of test  substance  in  blank controls
   (mg/L);
   Seb = 'apparent' concentration of test substance in blank control at end (mg/L).

       (7) Validity of results, (i)  Pressure readings should be used only from
vessels that  do not show pink coloration (see paragraph (j)(4) of this guideline).
Contamination by  oxygen is minimized by the use  of proper anaerobic handling
techniques.

       (ii) It should be considered that the test is valid if the reference substance
reaches a plateau that represents more than 60% biodegradation.  This should be
reevaluated if adsorptive and insoluble reference substances are included.

       (iii) If the  pH at the  end of the test has exceeded the range 7 ± 1  and
insufficient biodegradation has taken place,  repeat the test with increased buffer
capacity of the medium.

       (8) Inhibition of degradation. Gas production in vessels containing both
the test substance  and reference substance should be at least equal to that in the
vessels  containing  only  reference  substance;  otherwise,  inhibition  of  gas
production is indicated. In some  cases gas production in  vessels containing  test
substance without reference  substance will be lower than  that in the blank
controls, indicating that the test substance is inhibitory.

       (9) Test report.  The test  report  should  include  the  information in
paragraphs (k)(9)(i) through (k)(9)(iii) of this guideline.

       (i) Test substance: (A) Common name, chemical name, CAS number,
structural formula  and relevant physical-chemical properties;

       (B) Purity (impurities) of test substance.

       (ii) Test conditions: (A) Volumes of diluted digester liquor (Vi) and of the
headspace (Vh) in the vessel;

       (B) Description of the test  vessels, the  main  characteristics  of biogas
measurement (e.g.  type of pressure meter) and of the 1C analyzer;

       (C) Application of test substance and reference substance to test system:
test concentration used and any use of solvents;

       (D) Details of the inoculum used:  name  of  sewage treatment plant,
description of the source of wastewater treated (e.g. operating temperature, sludge
retention  time, predominantly domestic,  etc.), concentration, any  information
                                   20

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necessary to substantiate this,  and information on  any pretreatment of the
inoculum (e.g. predigestion, preexposure);

       (E) Incubation temperature;

       (F) Number of replicates.

       (iii) Results: (A) pH and 1C values at the end of the test;

       (B) Concentration of test substance at the beginning and end of the test, if
a specific measurement has been performed;

       (C) All the measured data collected in the test, blank, reference substance
and  inhibition  control vessels,  as appropriate (e.g.  pressure  in millibars,
concentration of inorganic carbon  (mg/L))  in  tabular form (measured  data for
headspace and liquid should be reported separately);

       (D) Statistical treatment of data, test  duration  and a  diagram of the
biodegradation of test substance, reference substance and toxicity control;

       (E) Percentage biodegradation of test substance and reference substance;
       reasons for any rejection of the test results;

       (F) Discussion of results.

       (1) References.

       (l)OECD  (1981).  302A-C: Inherent  Biodegradability and  303A-B:
Simulation Test  -  Aerobic  Sewage Treatment. Organization  for Economic
Cooperation Development, Paris.

       (2)OECD  (1992).  Ready  Biodegradability  301(A-F) and   Inherent
Biodegradability:  Zahn-Wellens/EMPA Test 302B.  Organization for Economic
Cooperation and Development, Paris.

       (3) Birch,  R.  R., C. Biver, R. Campagna, W.E. Gledhill, U. Pagga,  J.
Steber, H.  Reust and WJ. Bontinck (1989). WJ.  Screening  of chemicals for
anaerobic biodegradation.  Chemosphere 19,  1527-1550. (Also  published  as
ECETOC Technical Report No. 28, June 1988).

       (4) Shelton, D.R. and J.M. Tiedje (1984). General method for determining
anaerobic biodegradation potential. Appl. Environ. Microbiol. 47, 850-857.

       (5) Owen, W.F., D.C.  Stuckey, J.B. Healy, Jr., L.Y.  Young  and P.L.
                                  21

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McCarty (1979).  Bioassay for monitoring biochemical methane potential  and
anaerobic toxicity. Water Res. 13, 485-492.

       (6) Healy,  Jr., J.B.  and L.Y.  Young (1979). Anaerobic biodegradation of
eleven aromatic compounds to methane. Appl. Environ. Microbiol. 38, 84-89.

       (7) Gledhill,  W.E.   (1979).  Proposed   standard   practice  for  the
determination  of  the anaerobic biodegradation of organic chemicals. Working
document.  Draft  2  no.   35.24.  American  Society  for   Testing  Materials,
Philadelphia.

       (8) Battersby, N.S. and V. Wilson (1988). Evaluation of a serum bottle
technique for assessing the anaerobic biodegradability of organic chemicals under
methanogenic conditions. Chemosphere. 17, 2441-2460.

       (9)ASTM  El 192-92. Standard  Test  Method  for  Determining  the
Anaerobic Biodegradation Potential  of Organic Chemicals. American Society for
Testing and Materials, Philadelphia.

       (lO)OPPTS 796.3140 (1998).  Fate,  Transport and Transformation Test
Guidelines,  Anaerobic Biodegradability  of  Organic  Chemicals.  Office  of
Prevention, Pesticides  and Toxic Substances, U.S. Environmental  Protection
Agency.

       (11) ISO  11734 (1995).  Water  Quality  - Evaluation of  the ultimate
anaerobic biodegradation of organic compounds in digested sludge - Method by
measurement  of  the  biogas  production.  International   Organization  for
Standardization, Geneva.

       (12) ISO 13641-1 (2003). Water Quality - Determination of inhibition of
gas  production of anaerobic bacteria  - Part 1  General  Test.  International
Organization for Standardization, Geneva.

       (13) ISO 10634 (1995). Water Quality - Guidance for the preparation and
treatment of  poorly  water-soluble organic  compounds for  the subsequent
evaluation  of  their biodegradability  in  an  aqueous  medium.  International
Organization for Standardization, Geneva.

       (14) ISO 11923 (1997). Water Quality -  Determination  of  suspended
solids  by filtration through  glass-fibre filters. International  Organization for
Standardization, Geneva.

       (15) Pagga, U. and D.B. Beimborn (1993).  Anaerobic biodegradation test
for organic compounds. Chemosphere 27, 1499-1509.
                                  22

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