Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
DL-Menthol
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Menthol is readily biodegradable with 76 - 92 % after 28 days (Haarmann & Reimer, 2003). Therefore the screening criteria for P and vP are not fulfilled.

The partition coefficient Log Kow for DL-Menthol is determined as 3.4 using HPLC method (Griffin, 1999) and the maximum BCF of DL-Menthol is determined as 15 (MITI, 1985). Thus the substance does neither fulfill the criteria for being B nor vB.

For algae a NOEC of 2.31 mg/L was determined in a 72 h growth inhibition study. No L(E)C50 < 0.01 mg/L was determined for DL-Menthol. The most critical EC50 of 16.2 mg/L was determined for algae after 72 h. Thus the substance is classified as not T.

The substance is neither classified as carcinogenic, (germ cell) mutagenic nor toxic for reproduction according to Directive 67/548/EEC and Regulation  EC no 1272/2008. The substance is neither classified as T, R48, Xn according to Directive 67/548/EEC nor specific target organ toxicity after repeated exposure according to Regulation EC No 1272/2008. Conclusively, DL-Menthol does not fulfill the criteria for T.