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Vermox®

Janssen

Tablett 100 mg
(svagt orange, rund, plan, 10 mm, ena sidan med skåra märkt Me/100, andra sidan märkt JANSSEN)

Anthelmintikum

Aktiv substans:
ATC-kod: P02CA01
Läkemedel från Janssen omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Mebendazol

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

=

100.9566 (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) [5]

D

=

factor for dilution of waste water by surface water flow

 

=

10 (ECHA default) [5]

PEC (µg/L)

=

0.015366301 µg/L


2. PREDICTED NO EFFECT CONCENTRATION (PNEC)

2.1. Ecotoxicological studies

2.1.1. Algae


Acute

72-Hour Algal Growth Inhibition Test (Pseudokirchneriella subcapitata) (OECD 201) [1]

EγC50 72 h (yield) > 0.21 mg/L

NOECγ (yield) = 0.042 mg/L

ErC50 72 h (growth) >0.21 mg/L

NOECr (growth) = 0.042 mg/L


2.1.2. Crustacean


Acute

Water-flea (Daphnia magna) (OECD 202) [2,3]

EC50 48 h = 0.088 mg/L
NOEC 48 h = 0.024 mg/L (Survival)


Chronic

Not available.


2.1.3. Fish


Acute

Acute Toxicity of Mebendazole to Zebra Fish (Brachydanio rerio) (OECD 203) [4]:

EC50 96 h >100 mg/L (Survival)


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 the water flea Daphnia magna of 0.088 mg/L has been used for this calculation since it is the most sensitive of the three tested species.


PNEC = 0.088 mg/L/1000 = 0.088 µg/L


2.3. Environmental risk classification (PEC/PNEC ratio)


PEC/PNEC = 0.015366301 / 0.088 = 0.174617061 i.e. 0.1 < PEC/PNEC ≤ 1


Conclusion for environmental risk:

Use of Mebendazole has been considered to result in low environmental risk.


3. DEGRADATION

3.1. Biotic degradation

3.1.1. Ready biodegradation


No data on degradation available.


Conclusion for degradation:

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


4. BIOACCUMULATION

4.1. Partition coefficient octanol/water

The partition coefficient is determined at 23°C between n-octanol and an aqueous buffer solution at pH 6. A double extraction method was used. log Pow = 3.01 [6]


Conclusion for bioaccumulation:

As the log Pow< 4, Mebendazole has low potential for bioaccumulation.


5. REFERENCES

  1. Peither A., Toxicity of Mebendazole to Pseudolnrchneriella subcapitata (Formerly Selenastrum capricornuturn) in a 72-Hour Algal Growth inhibition test. RCC Study No. C08330. Janssen Study No. MEB-08-PREC-04; September 2008.

  2. Batscher R., Acute Toxicity of Mebendazole Polymorph C (RO17635) to Daphnia magna in a 48 hour immobilization test. RCC Studv No. 787724, Janssen Study No. MEB-00-PREC-05; January 31, 2001.

  3. Schmidt T., Acute Toxicity of Mebendazole Polymorph B (RO17635) to Daphnia magna in a 48 hour immobilization test. RCC Studv No. 787724, Janssen Study No. MEB-00-PREC-05; January 26, 2005.

  4. Peither A., Acute Toxicity of Mebendazole to Zebra Fish (Brachydanio rerio) in a 96-Hour Test. Harlan Laboratories Study No. C14562. Janssen Study No. MEB-08-PREC-05; Nov 26, 2008.

  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

  6. Janssen Research & Development Material Safety Data Sheet – Mebendazole, accessed Janury 2015