Risk Assessment of Manufactured Nanomaterials - Environmental and Human Health Impacts of Nanotechnology - page 390

Substance

General exclusions:
non-isolated intermediates, under
customs supervision, radioactive,
or polymer?

Y

STOP

N

STOP

> 1 tonne/year?

N

Y

> 10 tonnes/year?

N Y

All other available
information on chemical
properties, toxicological
information,
ecotoxicological
information

Physiochemical
properties

Toxicological
information

Ecotoxicological
information

Substance state Melting/freezing point
Boiling point Relative density
Vapour Pressure Surface tension
Water solubility Flash-point
Flammability Explosive properties
Self-ignition temperature
Oxidising properties Granulometry
Partition coefficient n-octanol/water
Viscosity Chemical name
Molecular structure

Acute toxicity
• Oral/dermal/inhalation route
• Short-term repeated dose toxicity
• Sub-chronic toxicity study
• Reproductive toxicity screening
• Developmental toxicity study
• Toxicokinetics
Skin irritation/corrosion
Eye irritation
Mutagenicity

Aquatic toxicity
• Short-term toxicity testing (Daphnia)
• Long-term toxicity testing (Daphnia)
• Long-term toxicity testing (fish)
Algal growth inhibition
Biodegradation/degradation

All available data
must be presented

N

> 100 tonnes/year?

Y N

> 10 tonnes/year? > 100 tonnes/year?

Y

N Y

Long term toxicity testing
2-generation reproductive study
Carcinogenicity study
In vivo testing

Adsorption/desorption screening test
Acute fish/daphnia/algae toxicity test
Bio-concentration
Effects on soil micro-organisms
Long term toxicity tests on soil
invertebrates/plants

Low Quantity Risk
Assessment Report

Full Risk Assessment Report

Figure 10.2 Schematic for the generalised risk assessment of a chemical substance being
manufactured or imported.

Following the initial trigger, further information is required for chemicals manu-
factured or imported at quantities above 10 tonnes/year (Table 10.1).
In contrast to the above, where the emphasis is on assessing the risks of a chemi-
cal prior to marketing and use (i.e. 'data before market'), retrospective risk assess-
ment may be undertaken after manufacture and is triggered for a number of
reasons and under a number of regulatory regimes. Biological impacts observed in
the fi eld may be one such trigger; for example in the case of endocrine disrupting
chemicals where a quantitative environmental risk assessment was undertaken
after impacts were observed in fi sh (Jobling et al. , 2006) and marine snails
(Vasconcelos et al. , 2006). Retrospective risk assessments are supported by the