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Temodal

MSD

Kapsel, hård 180 mg
(Tillhandahålls ej) (Kapslarna har en ogenomskinlig inre vit halva och en ogenomskinlig yttre orange halva och är märkta med svart bläck. Den yttre halvan är märkt ”Temodal”. Den inre halvan är märkt med ”180 mg”, Schering-Ploughs logo och två ränder.)

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ATC-kod: L01AX03
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  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Temozolomid

Miljörisk: Användning av temozolomid har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Temozolomid bryts ned långsamt i miljön.
Bioackumulering: Temozolomid har låg potential att bioackumuleras.


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Detaljerad miljöinformation


Environmental Risk Classification


Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:


PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.37*10-6*A(100-R)


PEC = 0.0015 μg/L


Where:

A = 11 kg (total sold amount API in Sweden year 2022, data from IQVIA) (Ref. I)

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 10 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. II)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. II)


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Green Algae (Pseudokirchneriella subcapitata) (OECD 201) (Ref. III):

EC50 72 h (growth rate) > 90 mg/L

NOEC = 40 mg/L


Crustacean, water flea (Daphnia magna):

Acute toxicity

EC50 48 h (growth rate and biomass) > 100 mg/L (OECD 202) (Ref. IV)

NOEC = 100 mg/L

No effects seen up to highest concentration tested


Fish, rainbow trout (Oncorhynchus mykiss):

Acute toxicity

LC50 96 h (mortality) > 100 mg/L (OECD 203) (Ref.V)

NOEC = 100 mg/L

No effects seen up to highest concentration tested


PNEC =90 μg/L (90,000 μg/L/1000 based on the most sensitive acute EC50 for the green algae with an assessment factor (AF) of 1000)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.0015/90 = 0.000017, i.e. PEC/PNEC ≤ .1 which justifies the phrase "Use of temozolomide has been considered to result in insignificant environmental risk.”


Degradation


Biotic degradation

Test results: 61% elimination (loss of parent) at Day 21, 83% to CO2 at Day 35 (OECD 301B) (Ref. VI)


Abiotic degradation

Hydrolysis:

Half-life = 69 days at pH 4 and < 1 day at pH 7 and pH 9 (OECD 111) (Ref. VII)


Justification of chosen degradation phrase:

83% of temozolomide degrades to the nonhazardous CO2 within 35 days. Therefore, significant mineralization is expected and thus the phrase “Temozolomide is slowly degraded in the environment” is chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow = 1.35 at pH 7

  • The partition coefficient (Kow) was determined for the equilibrium distribution of temozolomide between n-octanol and 0.1N HCl, and n-octanol and pH 7 phosphate buffer. Equal volumes of the aqueous component, containing about 1 mg/mL temozolomide, and n-octanol were agitated for 6 hours at ambient temperature. After centrifugation, both layers were assayed for temozolomide content by HPLC (Ref VIII).


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, the substance has low potential for bioaccumulation.


References

  1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2023 (data 2022)”.

  2. 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

  3. Huntington Life Sciences, 2006. "SCH 52365 Algal Growth Inhibition Assay," Study No. ESN 213/052201, HLS, England, 22 February 2006.

  4. Huntington Life Sciences, 2006. "SCH 52365 Acute Toxicity to Daphnia magna," Study No. ESN 212/052200, HLS, England, 22 February 2006.

  5. Huntington Life Sciences, 2006. "SCH 52365 Acute Toxicity to Rainbow Trout," Study No. ESN 211/052199, HLS, England, 22 February 2006.

  6. Huntington Life Sciences, 2005. "SCH 52365 Assessment of Ready Biodegradability: Modified Sturm Test," Study No. ESN 209/043479, HLS, England, 19 April 2005.

  7. Huntington Life Sciences, 2005. "SCH 52365 Abiotic Degradation: Hydrolysis as a Function of pH," Study No. ESN 208/043624, HLS, England, 20 July 2005.

  8. Schering Plough Research Institute. CMC Section 4.A.1.2 Temozolomide (SCH 52365) Capsules - Physical Chemical Characterization.