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PBT assessment

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PBT assessment: overall result

Reference
Name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl acetate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl acetate
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, 2014).

Persistence

In a valid hydrolysis study in accordance with OECD guidelines the read-across substance menthyl acetate was found to hydrolyse under environmental conditions with a half life of 133 h at 25 °C and pH 7 which is far below the P(vP) trigger criterion of T1/2 > 40 (60) days) for the PBT discussion. The expected products of hydrolysis L-menthol and acetic acid are readily biodegradable. The substance is therefore not (v)P.

Bioaccumulation

The substance has a log Kow of 4.39 (OECD 123). Thus, the substance does not meet the screening criterion for bioaccumulation (log Kow ≥ 4.5) and it is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Toxicity

A long-term toxicity result for Pseudokirchneriella subcapitata is available with an ErC10 (72 h) of 0.61 mg/L (measured). Moreover, the substance is not classified for human toxicity according to Annex XIII of Regulation (EC) No 1907/2006 based on Regulation (EC) No 1272/2008 (6th ATP). Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the substance is not considered to meet the T criterion.

In conclusion, the substance is not considered to be PBT or vPvB.