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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence assessment:The test substance meets the criteria of ready biodegradability in an OECD 301F Manometric Respirometry test, with 89% biodegradation in 28 days. Based on the screening criteria for persistence, the substance is not P since it is readily biodegradable.  

 

Based on structural similarity to 2-amino-2-methylpropanol, the impurity1-propanol -2-methyl-2- (methylamino)- is expected to bereadily biodegradable.Based on the screening criteria for persistence, the substance is not P.

 

Bioaccumulation assessment: The substance has a low potential to bioaccumulate because of its low log Powvalue (–0.63at 20°C) and its high water solubility (miscible). Screening criteria for bioaccumulation states that test substances with log Powvalues ≤ 4.5 are not B and not vB.

The impurity1-propanol -2-methyl-2- (methylamino)- has an estimated log Pow = –0.28.  Screening criteria for bioaccumulation states that substances with log Powvalues ≤ 4.5 are not B and not vB.

Toxicity Assessment: Acute aquatic toxicity values for the test substance:

LC50 for freshwater fish: 190 mg/L

LC50 for marine water fish: 184 mg/L

EC50/LC50 for freshwater invertebrates: 193 mg/L

EC50/LC50 for marine water invertebrates: 179 mg/L

EC50/LC50 for freshwater algae: 565.5 mg/L

 

Since these values are more than 1700-fold higher than the 0.1 mg/L threshold for toxicity (T), the test substance is not T.

 

Mammalian toxicity: 2-Amino-2-methyl-propanol is not classified as mutagenic, carcinogenic or a reproductive toxicant. Therefore it is not classed as T based on mammalian toxicity.

 

Based on structural similarity to 2-amino-2-methylpropanol, the impurity 1-propanol -2-methyl-2- (methylamino)- is expected to have ecotoxicity endpoint values greater than the threshold for toxicity (T). Thus, the impurity is not T.