Monalazone disodium

PBT assessment

PBT assessment: overall result

Reference

Name:

Monalazone disodium_Lead

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Monalazone disodium_Lead

PBT status:

the substance is not PBT / vPvB

Justification:

Evidence of non-P / non-vP properties:

Screening tests for biodegradation in water: readily biodegradable, but failing 10-day window. % Degradation of test substance: 13.29 after 3d (% degradation (CO2 evolution)) 56.91 after 13d (% degradation (CO2 evolution)) 73.17 after 29d (% degradation (CO2 evolution)) The mean per cent degradation of the test item was 73.17% at the end of the test while, the percent degradation of the reference item was 79.58% and the toxicity control was 48.09% at the end of the test. Based on the results, it was concluded that the test item, Monalazone disodium, is biodegradable but not readily biodegradable as the mean degradation achieved is less than 60% pass level in a 10-day window period within the 28-day period of the test.

Evidence of non-B / non-vB properties:

Log Kow ≤ 4.5. The mean partition coefficient (n-octanol/water) of the test item, Monalazone Disodium was 1.45 (pH 7.55) at a temperature of 25ºC.

Evidence of non-T properties:

The substance:

• is not classified H350 (carcinogenicity, Cat. 1A, 1B), H340 (germ cell mutagenicity, Cat. 1A, 1B), H372 (STOT-RE, Cat.1), H373 (STOT-RE, Cat.2), H350i (carcinogenicity, route of exposure), H360 (reproductive toxicity, Cat.1), H361 (reproductive toxicity, Cat.2)


• acute data E(L)C50 > 0.01 mg/L


• acute data E(L)C50 > 0.1 mg/L


• screening assessment for P and B: Log Kow < 4.5 or readily biodegradable

No further assessment necessary.