Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.031 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.306 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.056 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:
0.093 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
246.67 mg/kg food
Assessment factor:
30

Additional information

L(E)C50 values for all three trophic levels are available. The PNEC aqua (freshwater) is derived from the EC50 value of 30.6 mg/L found in the acute aquatic toxicity study with freshwater invertebrates as the most sensitive species tested. The PNEC STP is derived from the non-inhibitory concentration of 20 mg/L applied in the toxicity control of the valid study on ready biodegradability. The PNEC sediment and PNEC soil have been derived by using the equilibrium-partitioning method. The PNEC oral is based on a NOAEL of 370 mg/kg bw/day derived from a chronic study with DL-menthol in rats.

Conclusion on classification

Available aquatic toxicity data:

The most sensitive aquatic species was Daphnia with an 48 -hour EC50 of 30.6 mg/L. The ErC50 value after 72 hours in a valid algal toxicity study with the L-menthan-3-one was 58 mg/L and the ErC10 value was 31 mg/L. No LC50 value was derived in the short-term fish toxicity study.

Acute aquatic toxicity classification:

Based on above stated L(E)C50 data, no classification for acute aquatic toxicity necessary according to both the CLP and the DSD Regulation.

Chronic aquatic toxicity classification - GHS:

Since the 2nd Amendment of the CLP Regulation, data from long.term studies (if ever available) are preferred over data from acute studies for chronic aquatic toxicity classification. The only available long-term study is the algal growth inhibition study, which revealed an EC10 of 31 mg/L, which does not trigger classification. The EC50 of 30.6 mg/L coming from the acute Daphnia study also does not trigger classification, as the substance is rapidly degradable and has a log Kow < 4.0.

Chronic aquatic toxicity classification - DSD:

In the DSD Regulation data from long-term studies had not yet been considered for chronic aquatic toxicity classification. Based on DSD Regulation 67/548/ECC, Annex VI, 5.2.1.2., a substances shall be classified as dangerous for the environment R52/53 if the L(E)50 is within the range 10 - 100 mg/L and the substance is not readily degradable. While the EC50 values for Daphnia and algae are within above stated concentration range, the substance on the other hand is considered as readily biodegradable, thus no classification is applicable.