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Caelyx pegylated liposomal

Janssen

Koncentrat till infusionsvätska, lösning 2 mg/ml
(Dispersionen är steril, halvgenomskinlig och röd)

Cytostatikum

Aktiv substans:
ATC-kod: L01DB01
Läkemedel från Janssen omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Doxorubicin

Miljörisk: Användning av doxorubicin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Det kan inte uteslutas att doxorubicin är persistent, då data saknas.
Bioackumulering: Doxorubicin har låg 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)

=

0.97599 kg (total sold amount API in the most recent sales data for Sweden (2019) was distributed by IQVIA/LIF in 2020)

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) [1]

D

=

factor for dilution of waste water by surface water flow

 

=

10 (ECHA default) [1]

PEC (µg/L)

=

0.000148553 µg/L


2. PREDICTED NO EFFECT CONCENTRATION (PNEC)

2.1. Ecotoxicological studies

2.1.1. Algae

Algal growth inhibition test with the green alga (Pseudokirchneriella subcapitata) (OECD 201) [2]:


EbC50 72 h (inhibition) = 4.1 mg/L

NOECb (inhibition) = 1.9 mg/L

ErC50 72 h (growth) = 11 mg/L

NOECr (growth) = 1.9 mg/L


2.1.2. Crustacean

Acute

Acute toxicity in the water-flea (Daphnia magna) (OECD202) [3]:


EC50 48 h (immobilization) = 1.8 mg/L

NOEC 48 h (immobilization) = 0.07 mg/L


Chronic

No data available


2.1.3. Fish

Acute

Acute toxicity in fish (Brachydanio rerio) (OECD 203) [4]:

LC50 96 h (semi-static) = 68 mg/L

NOEC 96 h (semi-static) = 46 mg/L


Chronic

No data available


2.1.4. Other ecotoxicity data

Activated sludge respiration inhibition test (OECD 209) [5]:


EC50 3h (respiration inhibition): > 1000 mg/L

NOEC 3h (respiration inhibition): 246 mg/L.


2.2. Calculation of Predicted No Effect Concentration (PNEC)

PNEC (µg/l) = lowest EC50/1000, where 1000 is the assessment factor used. EC50 for the water-flea (Daphnia magna) of 1.8 mg/L has been used for this calculation.


PNEC = 1.8 mg/L/1000 = 0.0018 mg/L = 1.8 µg/L


2.3. Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.000148553 / 1.8 = 0.0000825294 i.e. PEC/PNEC ≤ 0.1


Conclusion for environmental risk:

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


3. DEGRADATION

No data on degradation available.


The potential for persistence of Doxorubicin cannot be excluded, due to lack of data.


4. BIOACCUMULATION

4.1. Partition coefficient octanol/water

The partition coefficient octanol/water [6] is expected to be:
log Dow = 1.27


Conclusion for bioaccumulation:

Doxorubicin has a low potential for bioaccumulation.


5. REFERENCES

  1. 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

  2. Bätscher R, Doxorubicin HCl: Toxicity to Scenedesmus subspicatus in a 72-hour algal Growth Inhibition Test, Following OECD Guideline #201; RCC Ltd Environmental Chemistry & Pharmanalytics Switzerland – RCC Study Number A43751; JNJ Study No. RMD 744; August 17, 2006

  3. Bätscher R, Doxorubicin HCl: Acute toxicity to Daphnia magna in a 48-hour Immobilization Test, Following OECD Guideline #202; RCC Ltd Environmental Chemistry & Pharmanalytics Switzerland – RCC Study Number A43773; JNJ Study No. RMD 745; August 18, 2006.

  4. Bätscher R, Doxorubicin HCl: Acute toxicity to Zebra fish (Brachydanio rerio) in a 96-hour Semi-static Test, Following OECD Guideline #203; RCC Ltd Environmental Chemistry & Pharmanalytics Switzerland – RCC Study Number A43795; JNJ Study No. RMD 746; August 17, 2006.

  5. Büche C, Doxorubicin HCl: Toxicity to Activated sludge in a Respiration Inhibition Test, Following OECD Guideline #209; RCC Ltd Environmental Chemistry & Pharmanalytics Switzerland – RCC Study Number A43817; JNJ Study No. RMD 747; April 24, 2006.

  6. ChemIDPlusAdvanced, RN 23214-92-8, https://chem.nlm.nih.gov/chemidplus/rn/23214-92-8