Butanamide, 2-amino-, hydrochloride (1:1), (2S)-

PBT assessment

PBT assessment: overall result

Reference

Name:

(S)-2-Aminobutanamide hydrochloride

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

(S)-2-Aminobutanamide hydrochloride

PBT status:

the substance is not PBT / vPvB

Justification:

8. PBT AND vPvB ASSESSMENT

8.1. Assessment of PBT/vPvB Properties

8.1.1. PBT/vPvB criteria and justification

8.1.1.1. Assessed substance: substance itself

PBT status of the assessed substance: the substance is not PBT / vPvB

 

8.1.1.1.1. Persistence assessment

​Evidence of non-P / non-vP properties

Screening criteria

- Not P / vP based on ready biodegradability: As determined in a GLP study according to OECD 301A, the substance was shown to be readily biodegradable.

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Conclusion on P / vP properties:not P/vP.

 

8.1.1.1.2. Bioaccumulation assessment

​​Evidence of non-B / non-vB properties

Screening criteria

- Remarks on criterion “Log Kow<=4.5”: The log Pow of the substance at 20°C is -3.57, as estimated from the ratio n-octanol solubility (133.2 mg/L) and water solubility (490 g/L) in a GLP study according to OECD 107.

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Conclusion on B / vB properties:not B/vB.

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8.1.1.1.3. Toxicity assessment

​Conclusion on T properties:No conclusion can be reached based on available information.

 

- Environmental toxicity: All acute L(E)C50 values are ≥ 0.1 mg/L (>100 mg/L) and therefore this screening criterion for T is not fulfilled. The NOEC to algae is 100 mg/L. For a definitive classification as not T, a long-term aquatic NOEC ≥ 0.01 mg/L to daphnia (and/or fish) would be necessary.

- Human health toxicity: The substance is not considered to fulfil the toxic criterion as:

-- The substance does not meet the criteria for classification as carcinogenic, germ cell mutagenic or toxic for reproduction according to the CLP Regulation;

-- There is no other evidence of chronic toxicity; the substance does not meet the criteria for classification as STOT RE 1 or STOT RE 2 according to the CLP Regulation

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8.1.2. Summary and overall conclusions on PBT or vPvB properties

​Overall conclusion:Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.

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Justification:

The screening criteria as mentioned in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT assessment are used to decide whether the substance potentially fulfils the PBT or vPvB criteria. As the substance was shown to be readily biodegradable, the substance is not P/vP. Based on the log Pow (and water solubility) of the substance, the substance is also not B/vB. Although the substance does not fulfil the toxic criterion with regard to human health toxicity and the acute L(E)C50 values are >100 mg/L, a definitive classification as not T is not possible, due to the lack of chronic environmental toxicity studies. However, since the substance is not P/vP and not B/vB, it can be concluded that the substance is not PBT/vPvB.