Miljöpåverkan (Läs mer om miljöpåverkan)
Ekonazol
Miljörisk:
Användning av ekonazol har bedömts medföra låg risk för miljöpåverkan.
Nedbrytning:
Det kan inte uteslutas att ekonazol är persistent, då data saknas.
Bioackumulering:
Det kan inte uteslutas att ekonazol kan bioackumuleras, då data saknas.
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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) |
= |
301.6933 kg (total sold amount API in the most recent sales data for Sweden (2017) was distributed by IQVIA / LIF in 2018) |
|
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) |
= |
0.0459 µg/L |
2. PREDICTED NO EFFECT CONCENTRATION (PNEC):
2.1. Ecotoxicological studies
2.1.1 Algae
Growth inhibition test with the green algae Pseudokirchneriella subcapitata (OECD 201) [2]:
ErC50 72 h = 0.17 mg/L
NOECr 72 h = 0.034 mg/L
2.1.2 Crustacean
Acute Toxicity to water fleas Daphnia magna (OECD 202) [3]:
EC50 48 h = 0.26 mg/L
NOEC 48h < 0.053 mg/L (immobilization)
2.1.3 Fish
Acute Toxicity to Zebra fish (Brachydanio rerio) (OECD 203) [4]:
LC50 96 h = 0.23 mg/L
NOEC 96h = 0.16 mg/L (Mortality)
2.2. Calculation of Predicted No Effect Concentration (PNEC)
PNEC (µg/l) = lowest EC50/1000, where 1000 is the assessment factor used.
The EC50 for the green alga Pseudokirchneriella subcapitata has been used, as this was the most sensitive of the three species tested (algae, water flea and fish). No NOEC values were used to derive the PNEC as they were statistically calculated and not experimentally derived.
PNEC = 0.17 mg/L / 1000 = 0.17 µg/L ≈ 0.2 µg/L
2.3. Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.0459 µg/L / 0.2 µg/L = 0.2296, i.e. 0.1 < PEC/PNEC ≤ 1
Conclusion for environmental risk:
Use of econazole and econazole nitrate has been considered to result in low environmental risk.
3. DEGRADATION
No data available.
The potential for persistence of econazole and econazole nitrate cannot be excluded, due to lack of data.
4. BIOACCUMULATION
No data available.
The potential for persistence of econazole and econazole nitrate cannot be excluded, due to lack of data.
5. REFERENCES
-
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
-
Kirkwood A.; Econazole nitrate - 27-hour toxicity test with freshwater green alga Pseudokirchneriella subcapitata; Smithers Viscient Study No. 13751.6175; Janssen Study No. RMD1125; January 18, 2011.
-
Sayers L.E.; Econazole nitrate – Acute toxicity to water fleas (Daphnia magna) under static conditions; Smithers Viscient Study No. 13751.6176; Janssen Study No. RMD1126; January 7, 2011.
-
Sayers L.E.; Econazole nitrate – Acute toxicity to zebra fish (Brachydanio rerio) under static-renewal conditions; Smithers Viscient Study No. 13751.6177; Janssen Study No. RMD1127; April 19, 2011.
Triamcinolonacetonid
Miljörisk:
Användning av triamcinolon har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Det kan inte uteslutas att triamcinolon är persistent, då data saknas.
Bioackumulering:
Triamcinolon har låg potential att bioackumuleras.
Läs mer
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) |
= |
8.302885 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) [4] |
|
|
D |
= |
factor for dilution of waste water by surface water flow |
|
= |
10 (ECHA default) [4] |
|
|
PEC (µg/L) |
= |
0.001263757 µg/L |
2. PREDICTED NO EFFECT CONCENTRATION (PNEC)
2.1. Ecotoxicological studies
Growth inhibition test with green algae Pseudokirchneriella subcapitata (OECD 201) [1]:
EbC50 72 h > 10 mg/L
NOECb ≥ 10 mg/L
ErC50 72 h > 10 mg/L
NOECr 72 h ≥ 10 mg/L
Acute Toxicity to water fleas Daphnia magna (OECD 202) [2]:
EC50 48 h > 10 mg/L (immobilization or lethargy)
NOEC ≥ 10 mg/L (immobilization or lethargy)
Acute Toxicity to Zebra fish (Brachydanio rerio) (OECD 203) [3]:
LC50 96 h > 10 mg/L
NOEC ≥ 10 mg/L
2.2. Calculation of Predicted No Effect Concentration (PNEC)
PNEC (µg/l) = lowest EC50/1000, where 1000 is the assessment factor used.
The EC50 for all three species (algae, water flea and fish) was > 10 mg/L.
PNEC = 10 mg/L / 1000 = 10 µg/L
2.3. Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.001263757 µg/L / 10 µg/L = 0.0001263757, i.e. PEC/PNEC ≤ 0.1
Conclusion for Environmental Risk:
Use of the medicine has been considered to result in insignificant environmental risk.
3. DEGRADATION
3.1. Biotic degradation
No data on degradation available.
Conclusion for degradation:
The potential for persistence cannot be excluded due to lack of data.
4. BIOACCUMULATION
4.1. Partition coefficient octanol/water
The partition coefficient octanol/water is log Dow = 1.16 [5]
Conclusion for bioaccumulation:
Triamcinolone has a low potential to bioaccumulate
5. REFERENCES
-
O’Brien E., Growth inhibition test with Pseudokirchneriella subcapitata; Smithers Viscient Study No. 1158.001.430; Janssen Study No. RMD1131; January 19, 2011
-
Biester M.A., Acute Toxicity to water fleas Daphnia magna; Smithers Viscient; Study No. 1158.001.110; Janssen Study No. RMD1132; January 26, 2011
-
Hasler T., Acute Toxicity to Zebra fish (Brachydanio rerio); Smithers Viscient; Study No. 1158.001.106; Janssen Study No. RMD1133; January 19, 2011
-
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
-
ChemIDPlusAdvanced,RN:71195-58-9, http://chem.sis.nlm.nih.gov/chemidplus/rn/71195-58-9