Registration Dossier
Registration Dossier
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EC number: 221-661-3 | CAS number: 3179-80-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence
In a ready biodegradation test (EU Method C.4-D, Manometric respirometry test), "Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]" proved to be readily biodegradable at a concentration of 25 mg/L (81% biodegradation after 28 d). By analogy with "Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]", "N-[3-(Dimethylamino)propyl]dodecanamide" can be considered to be readily biodegradable and thus, to be 'not P' and 'not vP'.
Bioaccumulation
No reliable log Kow or BCF measurements have been reported for "N-[3-(Dimethylamino)propyl]dodecanamide" or any of its analogous substances. Therefore, its bioaccumulation potential cannot be assessed.
Toxicity
No toxicity data on fish, aquatic invertebrate and algae have been reported for "N-[3-(Dimethylamino)propyl]dodecanamide". Moreover, although a read-across from ecotoxicity data available for "Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]" is possible, the lack of toxicity data on fish prevents the aquatic toxicity of "N-[3-(Dimethylamino)propyl]dodecanamide" to be assessed.
Otherwise, "N-[3 -(Dimethylamino)propyl]dodecanamide" is not classified as carcinogenic (category 1 or 2), mutagenic (category 1or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008. Besides, there is no evidence that the substance exhibits 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 (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.
Conclusion
Based on available data, "N-[3-(Dimethylamino)propyl]dodecanamide" is not P/vP while its bioaccumulation potential (B criteria) and toxicity potential (T criteria) cannot be assessed. Still, "N-[3-(Dimethylamino)propyl]dodecanamide" does not meet the PBT or vP/vB criteria according to Annex XIII of the REACH Regulation.
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