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  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Itrakonazol

Miljörisk: Användning av itrakonazol har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Itrakonazol är potentiellt persistent.
Bioackumulering: Itrakonazol har hög potential att bioackumuleras.


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Detaljerad miljöinformation

1. PREDICTED ENVIRONMENTAL CONCENTRATION (PEC):


The Predicted Environmental Concentration is calculated according to the following formula:


PEC (µg/L) = A x 109 x (100-R) / 365 x P x V x D x 100


Where:

A (kg/year)

=

15.6107 kg (total sold amount API in the most recent sales data for Sweden (2016) was distributed by QuintilesIMS in summer 2017)

R (%)

=

removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

 

=

0 % (worst-case scenario: no removal)

P

=

number of inhabitants in Sweden (9 x 106)

V (L/day)

=

volume of waste water per capita and day

 

=

200 (ECHA default) [7]

D

=

factor for dilution of waste water by surface water flow

 

=

10 (ECHA default) [7]

PEC (µg/L)

=

0.002376058 µg/L


2. PREDICTED NO EFFECT CONCENTRATION (PNEC)

2.1. Ecotoxicological studies

2.1.1. Algae

Algal growth inhibition test with the green alga (Selenastrum capricornutum):

EC50 10 days > 1000 mg/l (FDA 4.01) [2]

NOEC = 1000 mg/l (Growth Inhibition)


Blue-green alga (Microcystis aeruginosa):

EC50 10 days > 1000 mg/l (FDA 4.01) [3]

NOEC = 1000 mg/l (Growth Inhibition)


2.1.2. Crustacean

Acute

Water-flea (Daphnia magna):

EC50 48 h > 1000 mg/l (FDA 4.08) [4]

NOEC= 1000 mg/l (Survival)


Chronic

Not available


2.1.3. Fish

Acute

Zebra fish (Brachydanio rerio):

LC50 96 h > 1000 mg/l (FDA 4.11) [5]

NOEC = 1000 mg/l (Mortality)


Chronic

Not available


2.1.4. Other ecotoxicity data

Activated sludge respiration inhibition test (OECD 209) [1]

EC50 3h > 2000 mg/L

NOEC 3h ≥ 2000 mg/L


Result: Not readily biodegradable


2.2. Calculation of Predicted No Effect Concentration (PNEC)

PNEC (µg/l) = lowest EC50/1000 where 1000 is the assessment factor used. Since for all four species the EC50 > 1000 mg/l, this value was used to calculate the PNEC.


PNEC = 1000 mg/l/1000 = 1000 µg/l


2.3. Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.002376058/1000 = 0.000002376058 i.e. PEC/PNEC ≤ 0.1


Conclusion for environmental risk:

Use of Itraconazole has been considered to result in insignificant environmental risk.


3. DEGRADATION

3.1. Biotic degradation

3.1.1. Ready biodegradation

Itraconazole was investigated for its ready biodegradation in a 28-day manometric respirometry test according to FDA 3.11 [6]:


Intraconazole cannot be regarded as biodegradable since the 60% pass level was not reached within 28 days.


Result: itraconazole is potentially persistent.


4. BIOACCUMULATION

4.1. Partition coefficient octanol/water

The partition coefficient octanol/water was determined to be log Dow = 5.18 (pH = 3)


Conclusion for bioaccumulation:

As log Dow, Itraconazole has high potential for bioaccumulation.


5. REFERENCES

  1. Buche C., Itraconazole (R051211) Toxicity to Activated Sludge in a Respiration Inhibition Test. RCC Study No. A35098. Janssen Study No. RMD705. May 17, 2006.

  2. Vos E., The Effect of Itraconazole on the Growth of the Unicellular Green Algae Selenastrum capricornutum. Sponsor Report No. AASc / 0021. January 4, 1994.

  3. Woensel M., The Effect of Itraconazole (R051211) on the Growth of the Unicellular Blue Green Algae Microcytsis aeruginosa. Sponsor Report No. AAMa / 0005. January 20, 1994.

  4. Vos E., The Acute Toxicity of Itraconazole (R051211) in the water flea Daphnia magna. Sponsor Report No. ADK6 / 0036. December 9, 1993.

  5. Vos E., The Acute Toxicity of Itraconazole (R051211) in the Bluegill Sunfish Lepomis macrochirus. Sponsor Report No. AFLm / 0009. December 9, 1993.

  6. Van Ginneken I., The Biodegradability of Itraconazole (R051211) CO2 Evolution Test. Sponsor Report No. BDAS / 0054. December 22, 1993.

  7. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm