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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:

The PBT Assessment for 2-(dimethylamino)-2-methylpropan-1-ol (CAS 627-83-8) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).

Persistence

In the OECD 301D ready biodegradability test, limited biodegradation was observed (8% in 28 days). In the OECD 301F ready biodegradation test, no biodegradation was observed during the 28-day test period, though there were indications that the test substance was at least partially inhibitory to the microbial inoculum at the concentration tested. DMAMP is thus considered as persistent for the purpose of the PBT assessment.

 

Bioaccumulation

DMAMP has a log Kow of 0.09 and is therefore expected to have low bioaccumulation potential.

Toxicity

Long-term studies are not available. All short-term studies with DMAMP, available for all three trophic levels, demonstrate low aquatic toxicity. LC/EC50 values of 230 mg/L, 170 mg/L and 390 mg/L were obtained for fish, Daphnia and alga, respectively. Since the chemical risk assessment indicates no need to further investigate effects on aquatic organisms and for reasons of animal welfare, no long-term tests are proposed. Moreover, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (2nd ATP). Also, theres is no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure according to Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.