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REACH EUROPEAN CHEMICALS AGENCY (ECHA) – REGULATORY GUIDANCE ON USE OF
RADIOLABELLED COMPOUNDS

Information requirements under (REACH Regulation (EC) No 1907/2006) are
generated using technical guidance approved by the OECD and EU for conducting
Chemical Safety Assessments  to prepare Chemical Safety Reports which may be
required as part of a registration dossier.

Due to scientific and regulatory developments, test guidelines are updated and
the ECHA issues Endpoint Specific Guidance such as Chapter R.7b: Version 4.0,
June 2016

Specific reference, made by ECHA, to guidance where radiolabelled compounds are
employed, includes Environmental Fate; Degradation and Bioaccumulation:

OECD 314 Simulation Tests to assess biodegradability of chemicals in discharged
water (Note: OECD 303A is judged as complimentary to the OECD 314B) OECD 315
Bioaccumulation in Sediment-dwelling Benthic Oligochaetes, 2008 OECD 317
Bioaccumulation in Terrestrial Oligochaetes, 2010 OECD 305 Bioaccumulation in
Fish: Aqueous and Dietary Exposure, 2012


OF SPECIAL INTEREST IS CHAPTER R.7.9: DEGRADATION/BIODEGRADATION

Degradation of organic chemicals in the environment influences exposure and,
hence, it is a key parameter for estimating the risk of long-term adverse
effects on biota. Degradation rates, or half-lives, are determined in, or
default rates assigned from, laboratory-based degradation tests. These tests can
be simple screening tests (e.g. the OECD 301 ready biodegradability tests and
the OECD 111 hydrolysis as a function of pH test), or relatively complex higher
tiered simulation types of tests (e.g. the OECD 308 aerobic and anaerobic
transformation in aquatic sediment systems, OECD 309 aerobic and anaerobic
transformation in surface water and the OECD 303 aerobic sewage treatment).

There are also two draft OECD guidelines considering photolysis. These are (1)
Phototransformation of chemicals on soil surfaces and (2) Phototransformation of
chemicals in water-direct and indirect photolysis.


MORE SPECIFICALLY, GUIDANCE ON INFORMATION REQUIREMENTS AND CHEMICAL SAFETY
ASSESSMENT WHERE RADIOCHEMICALS MAY BE REQUIRED INCLUDE:

OECD 302A Inherent Biodegradability: A: Modified SCAS Test OECD 303A Simulation
Test - Aerobic Sewage Treatment A: Activated Sludge Units B: Biofilms OECD 304A
Inherent Biodegradability in Soil OECD 306 Biodegradability in Seawater OECD 307
Aerobic and Anaerobic Transformation in Soil OECD 308 Aerobic and Anaerobic
Transformation in Aquatic Sediment Systems OECD 309 Aerobic Mineralisation in
Surface Water - Simulation Biodegradation Test OECD 311  Anaerobic
Biodegradation of Organic Compounds in Digested Sludge - Method by Measurement
of Gas Production OECD 314 Simulation Tests to Assess the Biodegradability of
Chemicals Discharged in Wastewater


TESTING DATA ON DEGRADATION/BIODEGRADATION IS SUBJECT TO MORE DETAILED GUIDANCE
AND REFERENCE TO RADIOCHEMICALS INCLUDES:


SEWAGE TREATMENT

The fate of chemicals in sewage treatment plants can be studied in the
laboratory by using the Simulation Test.

Aerobic Sewage Treatment: Activated Sludge Units (OECD 303 A). Many chemicals
are normally present at very low concentrations, even in waste water, and
procedures for testing the biodegradation at suitably low concentrations (<100
μg/L) are presented in Annex 7 to the TG 303 A (OECD, 2006).

If a radiolabelled conventional activated sludge study (CAS) is performed and a
mass balance is done on the effluent and solids, it is possible to determine
biodegradation for any type of non-volatile compound.


MARINE BIODEGRADABILITY

Degradation of chemicals in seawater has generally been found to be slower than
that in freshwater tests inoculated with activated sludge and sewage effluent,
and, therefore, a positive result obtained during 28 (Closed Bottle Method) or
60 days (Shake Flask Method) in the biodegradability in Seawater test can be
regarded as evidence of a chemical’s potential for biodegradation in the marine
environment. When a chemical attains >60% ThOD (theoretical oxygen demand) or
>70% DOC (dissolved organic carbon) removal in a Biodegradability in Seawater
test (OECD 306), it can also be expected to fulfil the criteria for ready
biodegradability.


MODIFIED READY BIODEGRADABILITY TESTS

These consider biodegradability testing at low test substance concentrations and
assessing the biodegradation of poorly water soluble chemicals. Provided that
all other conditions in the Ready Biodegradability Tests are fulfilled, these
tests are regarded as Ready Biodegradability Tests and the results can be used
directly in classification.


TESTING AT LOW TEST SUBSTANCE CONCENTRATIONS DUE TO INOCULUM TOXICITY

Conducting studies at low concentrations may only be possible if the test
chemical is available containing an appropriate radioisotope. If this is not
possible then the primary biodegradability of the test chemical should be
measured using specific chemical analysis. If primary degradation is being
measured then an attempt should be made to identify any major degradation
products.


SOIL, SEDIMENT AND WATER

The following tests can be used to simulate the biodegradation of organic
chemicals under environmentally realistic conditions in soil, sediment or
surface water: Aerobic and Anaerobic Transformation in Soil (OECD 307); Aerobic
and Anaerobic Transformation in Aquatic Sediment Systems (OECD 308); and Aerobic
Mineralisation in Surface Water – Simulation Biodegradation Test (OECD 309).

When using radiolabelled chemicals, the label should be located in the most
recalcitrant part of the molecule when total mineralisation is assessed.


R.7.9.4.4 REMAINING UNCERTAINTY FOR DEGRADATION/BIODEGRADATION

Chemicals that fulfil the criteria for ready biodegradability are likely to
undergo rapid degradation in the environment under most conditions (OECD, 2006).
However, it must be recognised that these tests are very stringent and most
chemicals will not fulfil the pass criteria for ready biodegradability. For
chemicals that exhibit between 40 and 60% mineralisation in ready
biodegradability test, extensive primary biodegradation would have occurred even
though the use of non-specific endpoints such as DOC and BOD do not directly
measure this. Therefore there will remain a large degree of uncertainty about
the biodegradability of many chemicals and testing at higher levels or tiers
will be required.

Relevant environmental compartment Recommended biodegradation studies Freshwater
Freshwater simulation test (e.g. OECD 309) and/or CAS test (OECD 303)  
Freshwater sediment Freshwater water/sediment simulation test (e.g. OECD 308)
and/or CAS test (OECD 303)   Marine water Marine water simulation test (e.g.
OECD TG 309) and/or CAS test (OECD 303)   Marine water sediment Marine water
sediment simulation test (e.g. OECD 308) and/or CAS test (OECD 303)   Soil Soil
simulation test (e.g. OECD 307)

In 2008, the OECD published OECD TG 314. This test guideline aims to allow
checking of the fate of a substance on its way through the sewer system and
sewage treatment plant to the mixing zone in surface water. It comprises the
following five different component guidelines:

 * Sewer System, OECD 314A
 * Activated Sludge, OECD 314B
 * Anaerobic Digester Sludge, OECD 314C
 * Mixing Zone for Treated Effluent and Surface Water, OECD 314D
 * Mixing Zone for Untreated Wastewater and Surface Water, OECD 314E

Up to now OECD 314 has seldom been used and so there is little regulatory
experience of it under REACH. 


RADIOLABELLING

 * C-14 Custom Radiolabelling
 * 14C-Isotope of choice
 * Carbon-14 API to GMP
 * GLP Analytical and Metabolite Synthesis
 * Quality System
 * Techniques & Equipment
 * Industries
 * Registration Studies using 14C
 * REACH – 14C-Regulatory requirements


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Selcia Radiolabelled Pesticides

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