Detaljerad miljöinformation

Detailed background information

Physical properties^4-5

Solubility at 20°C: 18 600 µg/L

pKa: 4.75

Vapor pressure: 0.00407 mmHg

Molecular weight: 250.33

Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (μg/L) = (A*10⁹*(100-R))/(365*P*V*D*100) = 1.37*10^-6*A(100-R)

PEC = 0.055 μg/L

Where:

A =	404.22 kg (total sold amount API in Sweden year 2020, data from IQVIA)3.
R =	0 % removal rate (worst case scenario)
P =	number of inhabitants in Sweden = 10 * 106
V (L/day) =	wastewater volume per capita and day = 200 (ECHA default)1
D =	factor for waste water dilution by surface water flow = 10 (ECHA default)1

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Green alga (Scenedesmus subcapitus) (guideline OECD 201)⁷

EC₅₀ 72 h (growth rate, chronic toxicity) = 10 000 μg/L

NOEC 72 h (growth rate, chronic toxicity) = 1 510 μg/L

Daphnids (Daphnia magna) (guideline OECD 202)⁸

EC₅₀ 48 h (mobility, acute toxicity) = 21 000 μg/L

NOEC 48 h (mobility, acute toxicity) = 16 000 μg/L

Rainbow trout (Oncorhynchus mykiss) (guideline OECD 203)⁹

LC₅₀ 96 h (mortality, chronic toxicity) = 22 000 μg/L

NOEC 96 h (mortality, chronic toxicity) = 9 700 μg/L

Based on the lowest NOEC for the species Scenedesmus subcapitus and using the assessment factor² of 100 since we have at least one chronic toxicity study available, the PNEC is calculated to 1510/100 = 15.1 µg/L.

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.055 /15.1 = 0.0036, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase ”Use of gemfibrozil has been considered to result in insignificant environmental risk.”

Degradation

Biotic degradation

Ready biodegradability (guideline OECD 301B)⁶

38% degradation after 28 days. Gemfibrozil is therefore considered to be not readily biodegradable.

Justification of chosen degradation phrase

Gemfibrozil did not pass the ready degradability test, thus ”gemfibrozil is slowly degraded in the environment.”

Bioaccumulation

n-Octanol-Water Partition Coefficient (guideline OECD 107)⁵

Log P has been measured to 4.17 at pH 3, using the shake flask method.

With a pKa of 4.7, gemfibrozil is predominantly ionized at pH 7. Calculated data estimates the log D_ow at pH 7 to be 2.16, with a range from 3.95 at pH 5 to 0.76 at pH 9.

Justification of chosen bioaccumulation phrase

Since log D_ow < 4 at pH 7, gemfibrozil has low potential for bioaccumulation.

References

1. ECHA, European Chemicals Agency. 2016 Guidance on information requirements and chemical safety assessment chapter R16.

2. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment chapter R10.

3. IQVIA KG Consumption 2020 report.

4. Material Safety Data Sheet for Gemfibrozil. Pfizer Inc. Revised May 2014.

5. Study report 1131/473: Gemfibrozil: Determination of General Physico-Chemical Properties. July 2002.

6. Study report 1131/477: Gemfibrozil: Assessment of Ready Biodegradability; CO₂ Evolution Test. April 2002.

7. Study report 1131/476: Gemfibrozil: Algal Inhibition Test. July 2002.

8. Study report 1131/475: Gemfibrozil: Acute Toxicity to Daphnia Magna. June 2002.

9. Study report 1131/474: Gemfibrozil: Acute Toxicity to Rainbow Trout. July 2002.