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PBT assessment

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PBT assessment: overall result

Reference
Name:
(p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Taking into account the lack of biodegradation in a ready biodegradation test and in a simulation test, the substance (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate is considered as persistent or very persistent. Its log Kow is -2.8, and on the basis of this low log Kow, it is considered as not Bioaccumulable or Very Bioaccumulable. The chronic toxicity data assessed on daphnia (reproduction test) and on algae (inhibition of the growth) are higher than 0.1 mg/L and the acute toxicity on fish is higher than 1 mg/L. The substance is neither classified as carcinogenic (cat. 1A or 1B), nor germ cell mutagenic (Cat. 1A or 1B), nor toxic for the reproduction (cat. 1A, 1B or 2). It is not classified as “Specific Target Organ Toxicity Repeated Exposure category 1 or 2”. So it is considered as not Toxic. The substance (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate is P/vP, however it is neither B/vB, nor Toxic. Therefore (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate is Not PBT and Not vP/vB.

Likely routes of exposure:

Based on its physical-chemical properties, which are a very high water solubility (178 g/L), a vapor pressure ≤ 65 Pa , a log Kow of -2.8 and a log Koc of 0.63, the substance (p-ammoniophenyl)bis(2-hydroxyethyl) ammonium sulphate will be found mainly in the aquatic environment when released to the environment.