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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
2,2-Bis(2-aminopropoxy)propane
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
2,2-Bis(2-aminopropoxy)propane
PBT status:
the substance is not PBT / vPvB
Justification:

Conclusion on Persistance: vP (and P)

In a Ready Biodegradability Test according to OECD 301 D, the test item reached a biodegradation rate of 8.8 % after 28 days. Therefore, the test item is regarded to be not readily biodegradable (see IUCLID section 5.2.1). Therefore, the substance is considered to be potentially persistent (P) or very persistent (vP) in accordance with the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part C: PBT/vPvB assessment (Version 3.0, June 2017).

 

Conclusion on Bioaccumulation: not vB and not B

The log Pow-value of the test item was found to be 0.26 at 25 °C (see IUCLID section 4.7). This result is below the threshold value for bioaccumulative potential of log Pow > 4.5 as cited in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.11: PBT/vPvB assessment (Version 3.0, June 2017). Thus, the substance is not considered to be very bioaccumulative (vB) or bioaccumulative (B).

 

Conclusion on Toxicity: not T

The criterion for toxicity is not fulfilled, since the EC10 for aquatic organisms is >= 0.01 mg/L (72-h ErC10 and NOEC for the growth rate of algae was 12.2 mg/L and 9.4 mg/L, respectively); and the substance is not classified as carcinogenic, mutagenic or toxic for reproduction according to directive 67/548/EEC, or carcinogenic, germ cell mutagenic or toxic for reproduction according to Regulation EC No 1272/2008; and there is no evidence of chronic toxicity according to Directive 67/548/EEC, or specific target organ toxicity after repeated exposure according to Regulation 1272/2008.

 

Overall conclusion on PBT and vPvB

Based on the available information, the substance is not PBT / vPvB according to Regulation (EC) 1907/2006.