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Link to relevant study record(s)

Description of key information

There were no studies available in which the toxicokinetic properties of (2E)-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl) but-2-en-1 -ol were investigated

(2E)-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl) but-2-en-1-ol is a liquid with a molecular weight of 208, is slightly soluble in water (25.83 mg/L at 20°C) and is highly lipophilic (log Pow = 4.4).

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

There were no studies available in which the toxicokinetic properties of (2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl) but-2-en-1-ol were investigated.

(2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl) but-2-en-1-ol is a liquid with a molecular weight of 208, is slightly soluble in water (25.83 mg/L at 20°C) and is highly lipophilic (log Kow = 4.4).

In an oral repeated dose toxicity range-finding experiment, male and female rats exposed for 14 days showed increased liver weight in both sexes and a slight increase in kidney weight in females. These effects show clear signs of oral bioavailability of the test material.

In a recent 28-day repeated dose toxicity study conducted according to OECD guideline 422, biochemical changes in females at 1000 mg/kg bw/day, such as increased alanine aminophosphatase, alanine aminotransferase, cholesterol and bilirubin levels also confirmed that the metabolic function of the liver was affected by administration of (2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl) but-2-en-1-ol.

Also, in a 13-week repeated dose toxicity study conducted acording to OECD guideline 408, males and/or females exposed by diet to the substance showed slight non-adverse and reversible changes in haematological parameters (erythrocyte and haemoglobin concentrations, prothrombin time and haematocrit), biochemical parameters (urea, blood urea nitrogen and creatinine concentrations, glucose, alkaline phosphatase, albumin concentrations and albumin/globulin ratio), associated with increases in liver and/or kidney weights. These observations are thought to be indicative of adaptations of metabolism/excretion in the liver and kidneys, with absence of degenerative or functional change in liver or kidneys.

Taken together, these observations clearly show absorption, systemic exposure and metabolism/excretion by liver and kidneys via oral route.

 

As (2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl) but-2-en-1-ol has a molecular weight lower than 500 and a high lipophily (log Kow > 4) with a low volatility (vapour pressure < 0.1 Pa), dermal bioavailability is highly probable. Dermal penetration is confirmed by an acute dermal toxicity study where clinical sign such as diarrhea was observed, showing clear systemic effects after dermal exposure.

(2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl) but-2-en-1-ol has log Kow=4.4 at 35°C which is below 4.5, the limit of criterion for bioaccumulation, therefore it is considered that the substance has a low bioaccumulation potential.