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  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Bortezomib

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

=

0.0612885 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) [5]

D

=

factor for dilution of waste water by surface water flow

 

=

10 (ECHA default) [5]

PEC (µg/L)

=

0.00000932854 µg/L


2. PREDICTED NO EFFECT CONCENTRATION (PNEC)

2.1. Ecotoxicological studies

2.1.1. Algae


Algal growth inhibition test with the green alga (Scenedesmus subspicatus) (OECD 201) [1]:

EγC50 72 h (yield) = 0.30 mg/L

NOECγ (yield) = 0.10 mg/L

ErC50 72 h (growth) = 0.46 mg/L

NOECr (growth) = 0.10 mg/L


2.1.2. Crustacean


Acute

Acute toxicity to water-flea (Daphnia magna) (OECD 202) [2]:

EC50 48 h = 0.45 mg/L (Immobility)

NOEC = 0.17 mg/L


Chronic

Not available


2.1.3. Fish


Acute

Acute toxicity to zebra fish (Brachydanio rerio) (OECD 203) [3]:

LC50 96 h (mortality) = 1.1 mg/L

NOEC < 0.46 mg/L


Chronic

Not available


2.1.4. Other ecotoxicity data


Activated sludge respiration inhibition test (OECD 209) [4]

EC50 3 h > 1000 mg/L

NOEC 3 h = 714 mg/L


2.2. Calculation of Predicted No Effect Concentration (PNEC)


PNEC (µg/l) = lowest EC50/1000, where 1000 is the assessment factor used. ErC50 for the alga Scenedesmus subspicatus (0.46 mg/L) and EC50 for Daphnia magna (0.45 mg/L) have been used for this calculation since these two species are the most sensitive of the three tested species and for algae, growth is the most reliable endpoint.


PNEC = 0.45 mg/L/1000 = 0.45 µg/L


2.3. Environmental risk classification (PEC/PNEC ratio)


PEC/PNEC = 0.00000932854/0.45 = 0.0000207301 i.e. PEC/PNEC ≤ 0.1


Conclusion for environmental risk:

The calculated PEC/PNEC ratio is ≤ 0.1.

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


3. DEGRADATION


Not available.


Conclusion for degradation:

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


4. BIOACCUMULATION

4.1. Partition coefficient octanol/water


The partition coefficient octanol/water was to determined to be log Kow = 2.8 using unknown internal method. According to ChemSpider ACD/Percepta the log Kow = 2.45. [6].


4.2 Bioconcentration


According to ChemSpider ACD/BCF (pH7.4) = 15.60. [6]


Since BCF < 500, Bortezomib has low potential for bioaccumulation.


Conclusion for bioaccumulation:

Bortezomib has low potential for bioaccumulation.


5. PBT-assessment



PBT-criteria

Results for Bortezomib

P

DT50 freshwater > 40 days or

DT50 sediment > 120 days

No data available

B

BCF > 2000

BCF = 15.60

T

Chronic NOEC < 0.01 mg/L or

CMR or endocrine disrupting

NOECalgae = 0.10 mg//L

NOECdaphnia = 0.17 mg/L

NOECfish = 0.45 mg/L


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


6. REFERENCES

  1. Peither A., Bortezomib: Toxicity to Scenedsmus subspicatus in a 72-Hour Algal Growth Inhibition Test, OECD 201; RCC Ltd. Study A39958; JnJ Study RMD740; June 30, 2006.

  2. Peither A., Bortezomib: Acute Toxicity to Daphnia Magna in a 48-Hour Immobilization Test, OECD 202; RCC Ltd. Study A39971; JnJ Study RMD741; June 30, 2006.

  3. Peither A., Bortezomib: Acute Toxicity to Zebra Fish (Brachydanio rerio) in a 96-Hour Static Test, OECD 203; RCC Ltd. Study A39993; JnJ Study RMD742; June 30, 2006. 

  4. Grützner I., Bortezomib: Toxicity to Activated Sludge in a Respiration Inhibition Test, OECD 209; RCC Ltd. Study A40015; JnJ Study RMD743; March 28, 2006.

  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. Bortezomib, ChemSpider, ID # 343402, July 7, 2015, http://www.chemspider.com/Chemical-Structure.343402.html?rid=8f028c39-d830-42ba-a890-e9384a9affab