Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7.11 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
71.1 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.711 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
4 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.999 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
99.9 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.196 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
12.01 mg/kg food
Assessment factor:
300

Additional information

The PNEC values are determined for the substance itself by use of methods provided in the ECHA Guidance Chapter R.10 (May 2008).

Conclusion on classification

Nopyl acetate is an organic monoconstituent substance. It is very slightly soluble in water (15.1 mg/L according to the column elution method, 23.1 mg/L according to the slow-stirring method).

The short-term toxicity of nopyl acetate to aquatic organisms was investigated according to OECD guidelines and GLP.

The following toxicity values are available for the substance:

Fish Acute: 96h-LC50 = 11.44 mg/L (based on geometric measured concentrations)

Aquatic invertebrates: 48h-EC50 = 11.95 mg/L (based on geometric measured concentrations)

Algae: 72h-ErC50 = 7.11 mg/L (based on geometric measured concentrations)

The available lowest acute aquatic toxicity values range between 1 and 10 mg/L. There are no adequate chronic toxicity data available.

The degradation of the substance was investigated:

A reliable study was carried out according to OECD Guideline 301F and GLP. Under the conditions of this study, nopyl acetate was found readily biodegradable (78% of biodegradation on Day 28 based on oxygen consumption).

Information on bioaccumulation potential of the submission substance:

No fish BCF is available. log Kow is 4.24 (HPLC method) which indicates a potential for bioaccumulation.

CLP Classification (Regulation (EC) No 1272/2008)

Acute aquatic hazard:

Nopyl acetate is not classified for acute toxic hazard in accordance with CLP Regulation (lowest EC50 higher than 1 mg/L).

Chronic aquatic hazard:

Nopyl acetate is classified under CLP Regulation for chronic toxic hazard - Category 2. Adequate chronic toxicity data are not available. The lowest acute EC50 value (Algae) ranges between 1 and 10 mg/L. The substance is readily biodegradable but log Kow > 4.

M-Factor: not applicable.

DSD Classification (Directive 67/548/EEC)

Nopyl acetate is classified dangerous for the environment: N and R51/53. The lowest acute EC50 value ranges between 1 and 10 mg/L. The substance is readily biodegradable substance but Log Kow > 3.