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):
15.6 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
15.6 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
237 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

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

Additional information

Only one PNECs is considered for the risk assessment : PNEC water = 15.6 µg/l on L-Menthol which can be extrapolated to D-menthol.

The others PNECs (soils, sediments, secondary poisonning) should be higher due to the ready biodegradabitity and the low adsorption potential (endpoint 5.4.1).

In the worst case we decided to take into account the same values that we used for the L-Menthol. So we assume that all the 1600 tons of L-Menthol used as substance producted have a release into water of 0.02% and the water flow is 15.107 liter/d and 200000 m3/d in fresh and sea water.

The table compile all the exposure levels from EUSES (2009 volume and the generic use descriptors for fragrance compound (see annex)). The estimated risk characterization is display in the result table for the environment.

In the worst-case calculation approach all ratios PEC/PNEC are below 1

Local

Summary of local RCR estimation (for compounding assuming 0.02% of emission and 15.107as water flow)

Site

Volune undiluted / Number of working days per year

Local emission fraction

Standard fresh water flow (1)

PEC (µg/l)

PNEC (µg/l)

RCR

Holzminden

1608 / 330

0.0002

15.107

6.5

15.6

0.41

Generic scenario for a large/medium site

<1608/330

0.0002

15.107

<6.5

15.6

<0.41

Generic scenario for a small site

<<1608/330

0.0002

15.107

<<6.5

15.6

<<0.41

 

Regional

Summary of regional RCR assumption (for compounding assuming 0.002% of emission and 200.103m3 as water flow)

Site

Volune undiluted / Number of working days per year

Local emission fraction

Sea water volume (m3)

PEC (µg/l)

PNEC (µg/l)

RCR

Holzminden

1608 / 330

0.002

200,000

4.9

15.6

0.29

Generic scenario for a large/medium site

<1608 / 330

0.002

200,000

4.9

15.6

<0.29

Generic scenario for a small site

<<1608 / 330

0.002

200,000

<<4.9

15.6

<<0.29

Conclusion on classification

Based on the data for the D-Menthol:

- The substance is ready biodegradable

- Log Kow =3,15

- Fish : LC50 at 96h = 15,6 mg/l from L-Menthol with read-accross

- Daphnia : EC50 at 48h = 26,6 mg/l from L-Menthol with read-accross

- Algae (Desmodesmus subspicatus) : EC 50 at 72h = 21,4 mg/l with a NOEC at 9,65 mg/l from L-Menthol with read-accross

- Inhibition of activated sludge respiration was determined : EC50 = 237 mg/L from L-Menthol with read-accross

 

The substance does not meet the classification criteria for acute aquatic toxicity according to Regulation (EC) No. 1272/2008. As the substance D-menthol is readily biodegradable as shown in various tests and has a log Kow of 3.15 and thus less than 4 the substance also does not require classification fro chronic aquatic toxicity according to the criteria as laid down in Regulation (EC) No. 1272/2008.