Reaction mass of rel-{(1R,2S)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl}methanol and rel-{(1S,2R)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl}methanol

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Persistency :

From biodegradation screening studies (both Ready and Inherent), ROSYFOLIA undergoes substantial mineralisation, evidencing significant primary degradation, but does not attain the required pass levels.

In an OECD 301C, the test material was observed to degrade mainly to the Carboxylic Acid metabolite and some of the corresponding Aldehyde metabolite.

Conclusion : ROSYFOLIA is potentially P / vP, based on the limited studies available.

 

Bioaccumulation :

In an OECD 117 n-Octanol / Water partition coefficient determination by HPLC, ROSYFOLIA was determined to have a LogPow value of 3.5. Two impurities in the test sample representing realtive area 3.7% and 6.0%, respectively, had LogPow values of 3.2 and 3.9, also well below the LogPow of 4.5 threshold for potential B / vB screening.

The bioconcentration of Rosyfolia was studied in a flow-through system in Common Carp (C. carpio) according to Japanese CSCL test guideline, and comparable to the OECD 305 test guideline, also.  Three peaks were followed to determine the aqueous exposure concentration and concentrations in fish tissue.  A 28-day Uptake-Phase was performed.  The determined BCF values were low (<< 100 L/kg (wet wt.)) and thus a Depuration-Phase was not necessary.   

The flow-through set-up and exposure conditions were demonstrated to be stable.  Under these conditions, BCFs were estimated to be lower than 35 L/kg (Peak 1), 44 L/kg (Peak 2) and 28 L/kg (Peak 3). The BCF at steady state was determined to be 33 L/kg (Peak 2), 33 L/kg when normalized to 5% lipid content (BCFssl). These results indicate that ROSYFOLIA presents negligible risk to bioconcentrate in fish.

 

Toxicity :

Acute studies for three trophic levels of freshwater organisms exist for ROSYFOLIA (algae, daphnia and fish). Chronic values have not been established for either daphnia or fish, but EC10 and NOEC values exist for algae.

The following end-points were determined in the GLP aquatic toxicity studies :

OECD 203 (O. mykiss) : 96 hour LC50 = 3.2 mg/L

OECD 202 (D. magna) : 48 hour EC50 = 3.4 mg/L

OECD 201 (P. subcapitata) : 72 hour ErC50 = 8.6 mg/L

                                                  72 hour ErC10 = 2.4 mg/L

                                                   72 hour NOErC = 2.0 mg/L

All EC/LC50 values are >> 0.01 mg/L, as is the chronic EC10 and NOEC for algae.

ROSYFOLIA is not expected to be T.