General informations

Precautionary matrix completed by / responsible contact person

Brief description of the considered nanospecific field (type of nanomaterials, which surrounding, in which application)

Brief description of the considered (process) step (production, packaging, transport, further stages of processing, disposal, use...), brief description

Attention: when inputs are changed, the worksheet "Exposure" will be reset

Calculation of the precautionary need…

for employees

for consumers

for a specific disposal step (see footer 35 in the guidelines)

Which exposure pathway should be considered?

Respiratory passages (inhalative)

Skin (dermal)

Mouth (oral)

Frequency with which a person handles the nanomaterial:

monthly

weekly

daily

Which category can the nanomaterial be assigned to?

Carbon nanotubes and nanofibres

Nanosilver

other nanomaterials

Are coated / functionalised nanomaterials involved?

if yes, see statements in the guidelines, section 4.5

Nano-relevance

The precautionary matrix includes two approaches for the clarification of nano-relevance. The first approach is based on the EU proposed definition (2022/C 229/01). The second precautionary approach includes primary particles with external dimensions from 1 to 500 nm, as nano-specific effects on biological systems can also be caused by particle sizes of 100-500 nm.

Entry according to EU-proposed definition (2022/C 229/01)
Entry according to precautionary approach (external dimensions of primary particle from 1 to 500 nm)

Information on the life cycle

Potential effect

Potential exposure

Potential exposure of humans

E0 Basis for calculation

Exposure value is known (modelled or measured) (guidelines section 4.6.1)

Evaluation precautionary needs

The metrics of the precautionary matrix calculate different scores for employees, consumers and the environment. Scores above 25 indicate the need for precautionary measures (nanospecific action).
The scores are subject to uncertainties. The percentage shown specifies the probability of the actual score exceeding the threshold of 25 indicating the need for precautionary measures (Probability threshold 5%). (See section 4.7 of the Guidelines).

Please note: The precautionary matrix does not produce a definitive evaluation in terms of a risk assessment!

Calculated data

V = N × (W × E + I)

Unknown fraction

This diagram shows the unknown part of the result (red bar). If the unknown part is consequential, a few clarifications can lead to a significantly more favourable result.

guidelines section 4.4	A	V	U
I Information on the life cycle
I1 Is the origin of the (nanoscale) starting materials known? I1 Is the origin of the (nanoscale) starting materials known? yes partly no	-	-	-
I2 Is sufficient information available to complete the precautionary matrix for nanoscale starting materials? I2 Is sufficient information available to complete the precautionary matrix for nanoscale starting materials? yes partly no	-	-	-
I3 Are the subsequent users of the considered nanomaterials known? I3 Are the subsequent users of the considered nanomaterials known? yes partly no	-	-	-
I4 How accurately is the material system known, or can disturbing factors (e.g. impurities) be estimated? I4 How accurately is the material system known, or can disturbing factors (e.g. impurities) be estimated? accurately not accurately unknown	-	-	-

guidelines section 4.5	A	V	U
W Potential effect

W1 Reactivity
W1.1 Cell-free or calculated reactivity Input uncertainty
W1.1 Redox activity W1.1 Redox activity low medium high not known	-	-	-
W1.1 Photocatalytic activity W1.1 Photocatalytic activity low medium high not known	-	-	-
W1.1 Biological oxidative damage (BOD) W1.1 Biological oxidative damage (BOD) low medium high not known	-	-	-
W1.2 Cellullar reactivity Input uncertainty
W1.2 Induction of mediators of inflammation (IL-8, IL-1β, TNFα) W1.2 Induction of mediators of inflammation (IL-8, IL-1β, TNFα) low medium high not known	-	-	-
W1.2 ROS induction W1.2 ROS induction low medium high not known	-	-	-
W1.2 GSH reduction W1.2 GSH reduction low medium high not known	-	-	-
W1.2 Protein carbonylation W1.2 Protein carbonylation low medium high not known	-	-	-
W2 Stability Input uncertainty
W2AV Stability (half-life) of the primary particles present in the nanomaterial in the body W2AV Stability (half-life) of the primary particles present in the nanomaterial in the body hours days-weeks months not known	-	-
W2U Stability (half-life) of the primary particles present in the nanomaterial under environmental conditions W2U Stability (half-life) of the primary particles present in the nanomaterial under environmental conditions hours days-weeks months not known			-

Resultat Ihrer Eingaben

General informations

General informations

Nano-relevance

Information on the life cycle

I Information on the life cycle

Potential effect

W Potential effect

W1 Reactivity

W1.1 Cell-free or calculated reactivity

W1.2 Cellullar reactivity

W2 Stability

Potential exposure

Potential exposure of humans

E0 Basis for calculation

Evaluation precautionary needs

Calculated data

Unknown fraction