Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.042 mg/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:
0.083 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

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

Conclusion on classification

Short-term toxicity studies

Fish Acute: 96h-LC50 = 4.1 mg/L

Aquatic invertebrates: 48h-EC50 = 1.7 mg/L

Algae: 72h-ErC50 = 3.3 mg/L

The lowest acute aquatic toxicity values based on available data ranges between 1 and 10 mg/L. The long-term toxicity of registered substance to aquatic organisms was not investigated. Thus, there are no adequate chronic toxicity data available.

Biodegradation studies

The degradation of the substance was investigated according to OECD Guidelines: a reliable study carried out according to OECD Guideline 301D and GLP compliant is available on the registered substance. It was found readily biodegradable. Therefore, the substance is considered as rapidly degradable in aquatic system.

Information on bioaccumulation potential

log Kow and BCF for fish, extrapolated from data on main constituent d-limonene, are 4.38 and 726.2 L/kg ww, respectively.

CLP Classification proposal

It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).

Acute aquatic hazard: not classified. Reasoning: lowest E(L) C50 higher than 1 mg/L.

Chronic aquatic hazard: category 2. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L) C50 value range between 1 and 10 mg/L, rapidly degradable substance with log Kow > 4 and BCF >500.