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  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Cilastatin

Miljörisk: Användning av cilastatin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Cilastatin är potentiellt persistent.
Bioackumulering: Cilastatin har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Cilastatin


Environmental risk: Use of cilastatin has been considered to result in insignificant environmental risk.

Degradation: Cilastatin is potentially persistent.

Bioaccumulation: Cilastatin has low potential for bioaccumulation


Detailed background information


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) = 1.5*10-6*A*(100-R)


PEC = 0.009 μg/L


Where:

A = 61.5 kg (total sold amount API in Sweden year 2016, data from QuintilesIMS).

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. I)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Blue-Green Algae (Anabaena flos-aquae) (OECD 201) (Ref. II):

EC50 72 h (growth rate) > 99 mg/L

NOEC = 99 mg/L

No effects seen up to highest concentration tested


Green Algae (Pseudokirchneriella subcapitata) (OECD 201) (Ref. III):

EC50 72 h (growth rate) > 99 mg/L

NOEC = 99 mg/L

No effects seen up to highest concentration tested


Crustacean, water flea (Daphnia magna):

Acute toxicity (OECD 202)

EC50 48 hour (mobility) > 99 mg/L (Ref. IV)

NOEC = 99 mg/L

No effects seen up to highest concentration tested


Fish, fathead minnow (Pimephales promelas):

Acute toxicity

LC50 96 h (mortality) > 111 mg/L (OECD 203) (Ref. V)

NOEC = 111 mg/L

No effects seen up to highest concentration tested


PNEC = 9900 μg/L (99 mg/L / 10 based on the chronic NOEC for the blue-green algae with an assessment factor (AF) of 10), as recommended for effects testing of anti-microbials.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.009/9900 = 9.1 x 10-7, i.e. PEC/PNEC ≤ 1 which justifies the phrase

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


Biotic Degradation

Ready Biodegradation (OECD 301B)(Ref. VI)

The ready biodegradability of cilastatin was determined by the Carbon Dioxide Evolution Test Method (OECD Guideline 301B). The results indicated that the activated sludge inoculum was active, degrading the reference substance an average of 99.5% and that the test substance was not inhibitory to the inoculum at the concentration tested, as the toxicity control exceeded 25% degradation by Day 14 of the study. The average cumulative percent biodegradation for cilastatin was 27.7%, therefore it is not considered readily biodegradable.


Justification of chosen degradation phrase:

The lack of ready biodegradation justifies the phrase “Cilastatin is potentially persistent.”


Bioaccumulation

Partitioning coefficient (OECD 107) (Ref. VII)

log Kow = -3.53 at pH 7


Justification of chosen bioaccumulation phrase:

The log Kow < 4 justifies the phrase “Cilastatin has low potential for bioaccumulation.”


References

I. ECHA, European Chemicals Agency. 2012 Guidance on information requirements and chemical safety assessment.

http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm


II. Wildlife International, 2016. "CILASTATIN: A 72-HOUR TOXICITY TEST WITH THE CYANOBACTERIA (Anabaena flos-aquae)," Project No. 105P-121, Easton, MD, USA, 29 June 2016.


III. Wildlife International, 2016. "CILASTATIN: A 72-HOUR TOXICITY TEST WITH THE FRESHWATER ALGA (Pseudokirchneriella subcapitata)," Project No. 105P-120, Easton, MD, USA, 29 June 2016.


IV. EAG (formerly Wildlife International), 2016. "CILASTATIN: A 48-HOUR STATIC ACUTE TOXICITY TEST WITH THE CLADOCERAN (Daphnia magna)," Project No. 105A-229, Easton, MD, USA, 18 November 2016.


V. EAG (formerly Wildlife International), 2016. "CILASTATIN: A 96-HOUR STATIC ACUTE TOXICITY TEST WITH THE FATHEAD MINNOW (Pimephales promelas)" Project No. 105A-230, Easton, MD, USA, 18 November 2016.


VI. Wildlife International, 2016. "CILASTATIN: READY BIODEGRADABILITY BY THE CARBON DIOXIDE EVOLUTION TEST METHOD," Project No. 105P-181, Easton, MD, USA, 26 May 2016.


VII. EAG (formerly Wildlife International), 2016. "DETERMINATION OF THE n-OCTANOL/WATER PARTITION COEFFICIENT OF CILASTATIN BY THE SHAKE FLASK METHOD," Project No. 105C-1691, Easton, MD, USA, 5 August 2016.