Detaljerad miljöinformation

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 = 0.0014280058 µg/L

Where:

A = total actual API sales in Sweden for the most recent year 10.4234 kg (total sold amount API in the most recent sales data for Sweden (2022) was distributed by IQVIA in 2023)

R = 0

P = number of inhabitants in Sweden = 10 *10⁶

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference VI)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Reference VI)

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Pseudokirchneriella subcapitata) (guideline e.g. OECD 201):

Algal growth inhibition test with the green alga [Reference I]:

E_bC₅₀ 72 h (yield) = 0.73 mg/L

NOEC_b (yield) = 2.3 mg/L (see detailed information in footnote “a” of the table below)

E_rC₅₀ 72 h (growth)= 1.7 mg/L

NOEC_r 72 h (growth) = 0.37 mg/L

Crustacean (Daphnia magna) (water-flea) (guideline e.g. OECD 202):

Acute toxicity

Acute Toxicity to water fleas Daphnia magna [Reference II]

EC₅₀ 48 h > 2.91 mg/L

NOEC = 0.98 mg/L (immobility)

Chronic toxicity

Not available

Fish:

Acute toxicity

Zebra fish (Brachydanio rerio):

LC₅₀ 96 h = 1.4 mg/L (guideline e.g. OECD 203) [Reference III]

NOEC = 0.56 mg/L (mortality)

Chronic toxicity

Not available

Other ecotoxicity data:

Activated sludge respiration inhibition test (guideline e.g. OECD 209) [Reference IV]

EC₅₀ 3h > 1000 mg/L

NOEC 3h ≥ 1000 mg/L

PNEC (µg/l) = lowest LC₅₀/1000, where 1000 is the assessment factor used.

The LC₅₀ for the Zebra fish (Brachydanio rerio) 1.4 mg/L has been used for this calculation since it is the most sensitive of the three tested species. As for the algae species, the growth rate endpoint has been chosen in favour of that of the algae biomass in the determination of the PNEC. According to the OECD 201 guideline, preference should be given to the growth rate endpoint.

PNEC = 1.4 mg/L / 1000 = 1.4 µg/L

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.0014280058 /1.4 = 0.001020004 i.e. PEC/PNEC ≤ 0.1

Conclusion for environmental risk:

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

Degradation

Biotic degradation

Ready biodegradation

No data available.

Simulation studies: 

-

Conclusion for degradation:

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

Abiotic degradation

Hydrolysis: -

Photolysis: -

Bioaccumulation

Partition coefficient octanol/water:

The partition coefficient octanol/water was determined using the shaking flask method. [Reference V] log D_ow = 4.76 (pH = 3)

As log K_ow ≥ 4, Haloperidol has the potential to bioaccumulate in aquatic organisms.

Bioconcentration factor (BCF):

-

Conclusion for bioaccumulation: Haloperidol has high potential for bioaccumulation.

Excretion (metabolism)

-

PBT/vPvB assessment

-

References

1. Softcheck K., Haloperidol - Acute Toxicity to the Freshwater Green Alga Pseudokirchneriella subcapitata. Springborn Smithers Study No. 13674.6157. Janssen Study No. RMD893; March 1, 2007.

2. Schmidt T., Acute Toxicity of Haloperidol (R001625) to Daphnia Magna in a 48-Hour Immobilization Test. RCC Study No. 857835, Janssen Study No. RMD626; January 26, 2005.

3. Sayers L., Haloperidol - Acute Toxicity to Zebra Fish (Brachydanio rerio), Under Static-Renewal Conditions. Springborn Smithers Study No. 13674.6158. Sponsor Protocol/Project No. RMD895; March 12, 2007. 

4. McLaughlin S., Haloperidol - Activated Sludge Respiration Inhibition. Springborn Smithers Study No. 13674.6159. Janssen No. RMD896; March 8, 2007.

5. Jenkins K., Haloperidol - Determination of the Koc Coefficient Following OECD Guideline 121. Springborn Smithers Study No. 13674.6156. Janssen N. RMD892. April 9, 2007.

6. 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