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 = 3.3*10^-5 μg/L

Where:

A = 0.24 kg (total sold amount API in Sweden year 2020, data from IQVIA).

R = Removal rate= 0% (no data available)

P = number of inhabitants in Sweden = 10 *10⁶

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

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

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies*

Algal growth inhibition test with the green alga (Scenedesmus subcapitata) (OECD 201) [Ref. II]:

E_bC₅₀ 72h = 0.027 mg/L (Inhibition of growth)

NOEC_b 72h = 0.011 mg/L

E_rC₅₀ 72h = 0.034 mg/L (Inhibition of growth)

NOEC_r 72h = 0.011 mg/L

Crustacean (Latin name):

Acute toxicity

Water-flea (Daphnia magna) (OECD 202) [Ref. III]

EC₅₀ 48h = 3.5 mg/L (Immobilization)

NOEC 48h = 2.5 mg/L

Chronic toxicity

Not available.

Fish:

Acute toxicity

Zebra fish (Brachydanio rerio) (OECD 203): [Ref. IV]

EC₅₀ 96h = 1.5 mg/L (Survival)

NOEC 96h = 0.98 mg/L

Chronic toxicity

Not available.

Other ecotoxicity data:

Activated sludge respiration inhibition test (OECD 209) [Ref V]

EC₅₀ 3h > 1000 mg/L

NOEC 3h ≥ 1000 mg/L

Calculation of Predicted No Effect Concentration (PNEC)

PNEC (µg/L) = lowest EC50/1000, where 1000 is the assessment factor used. The EC₅₀ for the alga Scenedesmus subspicatus (0.03 mg/L) has been used for this calculation since it is the most sensitive of the three species tested.

PNEC = 0.03 mg/L / 1000 = 0.03 µg/L

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.000033/0.03 = 0.0011, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase Norelgestromin has been considered to result in insignificant/low/moderate/high environmental risk.

Conclusion for environmental risk:

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

Degradation

Biotic degradation

Ready degradability:

No information available.

Conclusion:

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

Bioaccumulation

The log P was predicted to be 4.40 using the ACD/Percpta module. [VI]

Conclusion:

Norelgestromin has a high potential for bioaccumulation.

References

1. 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

2. Batscher R., Norelgestromin: Toxicity to Scenedesmus subspicatus in a 72-hour Algal Growth Inhibition Test; RCC Study No. A41308; Janssen Study No. RMD728; May 16, 2006.

3. Batscher R., Norelgestromin: Acute Toxicity to Daphna magna in a 48-hour immobilization Test; RCC Study No. A41321; Janssen Study No. RMD729; May 16, 2006.

4. Batscher R., Norelgestromin: Acute Toxicity to Zebra Fish (Brachydanio rerio) in a 96-hour Static Test; RCC Study No. A41343; Janssen Study No. RMD730; May 16, 2006.

5. Grutzner I., Norelgestromin: Toxicity to Activated Sludge in a Respiration Inhibition Test; RCC Study No. A41365; Janssen Study No. RMD731; March 21, 2006.

6. ChemSpider, 2015, ID # 784336, http://www.chemspider.com/Chemical-Structure.7843336.html?rid=6fc436fc-fcb4-48da-aa62-abec58a15a76&page_num=0