Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
2.37 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
28.9 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:
48.4 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
83.3 mg/kg food
Assessment factor:
90

Additional information

Based on availability of acute aquatic toxicity data from three trophic levels the PNEC Aqua freshwater is derived. Based thereupon by using default calculations as described in ECHA guidance PNEC aqua marine water, PNEC aqua intermittent release are derived. The PNEC sediment (freshwater and marine water and PNEC soil are derived using the equilibrium partitioning method.

The PNEC for sewage treatment plant is based on the acute bacterial toxicity result from a sludge respiration inhibition test.

The PNEC oral predators is based on the NOAEL derived from the 90d feeding study with rats considering the applicable default correction factors.

Conclusion on classification

Based on the data of L-Menthol:

- The substance is ready biodegradable

- Log Kow = 3.15

- BCF = 0.5 - 15 l/kg

- Fish : LC50 at 96h = 15.6 mg/L

- Daphnia : EC50 at 48h = 26.6 mg/L

- Algae (Desmodesmus subspicatus) : EC 50 at 72h = 21.4 mg/L with a NOEC at 9.65 mg/L

- Inhibition of activated sludge respiration was determined : EC50 = 237 mg/L

 

The substance does not meet the classification criteria for acute aquatic toxicity according to Regulation (EC) No. 1272/2008 as the most sensitive EC50 is >1 mg/L.

The substance also does not require classification for chronic aquatic toxicity according to the criteria as laid down in Regulation (EC) No. 1272/2008 as L-Menthol is readily biodegradable and has a BCF of 15 and thus less than 500. The same applies when comparing to classification criteria according to Directive 67/548/EEC (Dangerous Substance Directive - DSD) as L-menthol is readily biodegradable neither long term nor short term classification is required.