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Primodium®

Janssen

Tablett 1 mg
Avregistreringsdatum: 2018-01-31 (Tillhandahålls ej) (Vit, rund, något välvd, märkt LOX/1 och JANSSEN)

Antidiarroikum

ATC-kod: A07DA05
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan

Loperamidoxid (vattenfri)

Miljörisk: Användning av loperamid har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Det kan inte uteslutas att loperamid är persistent, då data saknas.
Bioackumulering: Loperamid har låg potential att bioackumuleras.


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Detaljerad miljöinformation

1. PREDICTED ENVIRONMENTAL CONCENTRATION (PEC):

The Predicted Environmental Concentration is calculated using 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)

=

143.5265092 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) [5]

D

=

factor for dilution of waste water by surface water flow

 

=

10 (ECHA default) [5]

PEC (µg/L)

=

0.02184574 µg/L


2. PREDICTED NO EFFECT CONCENTRATION (PNEC):

2.1. Ecotoxicological studies

2.1.1 Algae

Algal growth inhibition test with green algae (Pseudokirchneriella subcapitata)
(OECD No. 201) [1]:

EbC50 72 h (biomass) = 76 mg/L

NOECb 72 h (biomass) = 14 mg/L

ErC50 72 h (growth rate) > 54 mg/L

NOECr 72 h (growth rate) ≥ 54 mg/L


2.1.2Crustacean

Acute

Water-flea (Daphnia magna) (OECD No. 202) [2]:

EC50 48 h (immobilization) > 56 mg/L
NOEC (immobilization) = 3.2 mg/L (immobilization)


Chronic

Not available


2.1.3Fish

Acute

Zebra fish (Brachydanio rerio) (OECD No. 203) [3]:

LC50 96 h (mortality) > 52.3 mg/L

NOEC (mortality) ≥ 52.3 mg/L


Chronic

Not available


2.2. Calculation of Predicted No Effect Concentration (PNEC)

PNEC (µg/l) = lowest EC50/1000, where 1000 is the assessment factor used. EC50 for fish 52.3 mg/L has been used for this calculation.


PNEC = 52.3 mg/L/1000 = 52.3 µg/L ≈ 50 µg/L


2.3. Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.02184574 µg/L / 50 µg/L = 0.000436915 i.e. PEC/PNEC ≤ 0.1


Since PEC/PNEC ≤ 0.1, Loperamide oxide has been considered to result in insignificant environmental risk.


Conclusion for environmental risk:

Use of Loperamide oxide been considered to result in insignificant environmental risk.


3. DEGRADATION

No data available


Conclusion for degradation:

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


4. BIOACCUMULATION

4.1 Partition coefficient octanol/water

Determination of the partition coefficient. [4]


The partition coefficient was determined at 24°C between n-octanol and an aqueous buffer solution at pH 8.1. Log Kow for Loperamide oxide = 3.49 (experimental value).


As the log Kow is < 4, Loperamide oxide has low potential for bioaccumulation.


Conclusion for bioaccumulation:

Loperamide oxide has low potential for bioaccumulation.


5. PBT-ASSESSMENT


PBT-criteria

Results for Loperamide oxide

P

DT50 freshwater > 40 days or

DT50 sediment > 120 days

-

B

BCF > 2000

-

T

Chronic NOEC < 0.01 mg/L or

CMR or endocrine disrupting

NOECalgae ≥ 54 mg/L

NOECcrustacean = 3.2 mg/L

NOECfish ≥ 52.3 mg/L


The PBT-criteria are not fulfilled. Therefore, Loperamide oxide is not considered a PBT-substance


6. REFERENCES

  1. Höger S.; Loperamide oxide (R058425): Toxicity to Pseudokirchneriella subcapitata in a 72-Hour Algal Growth Test; Harlan Study No. D03065; Janssen Study No. RMD1110; January 18, 2011.

  2. Höger S.; Loperamide oxide (R058425): Acute Toxicity to Daphnia magna in a 48-Hour Immobilization Test; Harlan Study No. D06957; Janssen Study No. RMD1112; January 19, 2011.

  3. Höger S.; Loperamide oxide (R058425): Acute Toxicity to Zebra Fish (Brachydanio rerio) in a 96-Hour Test; Harlan Study No. D03043; Janssen Study No. RMD1111; January 18, 2011.

  4. Stokbroekx S.; R058425: Physico-chemical characteristics; PC-CHAR 91-86; December 20, 1991.

  5. 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