Cyclopropanemethanol, 1-methyl-2-[(1,2,2-trimethylbicyclo[3.1.0]hex-3-yl)methyl]-

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

PERSISTENCY :

-Biodegradability - Only screening studies (Ready and Inherent) have been performed on Javanol, indicating that Javanol is neither Readily nor Inherently biodegradable under the test conditions, although an OECD 301C study demonstrated formation of the corresponding Carboxylic Acid metabolite. 

With this limited level of infomration, Javanol can be considered potentially P or vP;

 

BIOACCUMULATION :

-n-Octanol / Water Partition Coefficient - An OECD 117 study derives a LogPow of 4.5 for both isomers of Javanol, which would screen Javanol to be at the threshold of potentially B

Although the threshold for potential B, vB is set at a LogPow of 4.5, the n-Octanol/water partition coefficient does not provide any suitable information regarding the biotransformation of the test item within exposed species. Biotransformation / metabolism is a key process in the modification and elimination of xenobiotics from living systems, and, is, for the majority of modern chemicals, more indicative of potential to bioconcentrate / bioaccumulate than the simple lipophilicity of the substance as determined by LogPow.

 

To this end, the performnace and results of a full In vivo fish bioconcentrtion study (OECD 305 I) are presented under Section 5.3.1, and, summarised herebelow :

 

Under the test conditions applied Javanol (Peak 1 and Peak 2) were observed to have low- to very-low potential to bioaccumulate in Common Carp with BCF values for Peak 1 at the 9.44 ppb (Level 1) and 0.944 ppb Level 2) exposure levels on Day 28 of 26 and 33 L/kg whole body wet wt., respectively, and, 34 and 43 L/kg whole body wet wt. for Peak 2 at the same respective exposure levels.

Rapid depuration was observed, with an elimination half-life of 0.17 and 1.96 days. All detects in fish tissue decreased to below LOQ by Day 6.6 of the Depuration-Phase.

Separate analyses of the edible and non-edible tissue of fish indicated that bioaccumulation in the non-edible fraction was greater than that measured in the edible fraction (Non-Edible fraction : 30 - 90 L/kg wet wt.; Edible fraction : 17 - 55 L/kg wet wt.).

Javanol presents low- to very-low potential to bioaccumulate in fish.

Javanol is NOT B / vB.

 

TOXICITY :

A full set of freshwater studies exist for three trophic levels of water column species for short-term and long-term, chronic, end-point values.

The details are, as follows :

FISH TOXICITY :

Acute - 96 hr LC50 (OECD 203) = 1.02 mg/L

Chronic - 30-Day NOEC (OECD 210) = 0.055 mg/L

INVERTEBRATE - Daphnia magna :

Acute - 48 hr EC50 (OECD 202) = 0.38 mg/L

Chronic - 21-day NOEC (OECD 211) = 0.031 mg/L; 21-day EC10 (OECD 211) = 0.037 mg/L

ALGAE :

Acute - 72 hr ErC50 (OECD 201) = 0.74 mg/L

Chronic - 72 hr ErC10 (OECD 201) = 0.18 mg/L

All short- and long-term EC/LC50s and NOEC values are > 0.01 mg/L.

And substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 .

In addition no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. 

Javanol is NOT T.

 

Javanol is, therefore, not P B T,  nor vP / vB.