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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
(±)-neomenthol
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
>= 87.5 - <= 100 % (w/w)
Reference substance:
Composition 1
Reference substance:
Composition 1
This impurity is considered relevant for the classification and labelling of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

 

Persistency assessment

Two experimental studies are available investigating the biodegradability of the test substance. The studies were performed according to OECD 301D (GLP). After 28 d the substance was degraded to 79 - 92% meeting the 14-day window. Based on these results the substance is not considered to be P/vP based on the screening criteria.

 

Bioaccumulation

The substance has an experimental BCF of < 0.5-15 L/kg (OECD 305C) which is clearly below the trigger value of 2000 L/kg. Thus, the substance is not considered to be B/vB based on the criteria in REACh Annex XIII.

Toxicity

Aquatic studies are available for three trophic levels. All acute effect concentrations were clearly > 0.1 mg/L (lowest LC50 (96 h): 15.6 mg/L). Moreover, the substance is not classified as carcinogenic, mutagenic or toxic to reproduction (CMR). Since the P/vP and B/vB criteria are not met a further assessment is not necessary in accordance with ECHA Guidance R.11. However, since the chronic effect concentration from the algae study is > 0.01 (NOErC (72 h): 4.6 mg/L) the substance presumably does not meet the T-criterion.