Registration Dossier
Registration Dossier
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EC number: 930-859-5 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine
- Type of composition:
- boundary composition of the substance
- State / form:
- other: The substance was determined to be an amber coloured gelatinous solid.
- Reference substance:
- N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine
- Reference substance:
- N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine
- Name:
- N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine / 930-859-5
- Type of composition:
- legal entity composition of the substance
- State / form:
- other: The substance was determined to be an amber coloured gelatinous solid.
- Reference substance:
- N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine / 930-859-5
- Reference substance:
- N,N-bis(2-hydroxyethyl)-3-[(C16-18)alkoxy]-1-propanamine / 930-859-5
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence:
The substance is not readily biodegradable but has the potential to biodegrade; the substance did not meet the 60% biodegradation in the 10-day window but biodegraded 57% in the 28-day time period.
It is likely that the half-life will be less than 40 days and, therefore, it is determined that the substance is not persistent.
Bioaccumulation:
According to Annex XIII of REACH Regulation (EC) No 1907/2006, the bioaccumulation (B) criteria is considered to be met when the bioconcentration factor is aquatic species is higher than 2000. A substance fulfils the ‘very bioaccumulative’ criterion when the bioconcentration factor in aquatic species is higher than 5000.
There is no bioaccumulation study data, however, a way to indicate the bioaccumulation potential is by the partition coefficient - a log Kow is >/= 4 suggests that the substance is subject to bioaccumulation. The Kow for the test item is 1.74 x 105(log Kow > 5.2) which suggests that there is the potential to bioaccumulate. However, a bioaccumulation concentration factor (BCF) has been predicted using Epi Suite which determined the BCF value to be 53 L/kg. Although, an experimentally determined BCF value via the OECD 305 provides a better determination of bioaccumulation potential and should be used when available, this is not a testing requirement at this level of registration.
As we don’t have the bioaccumulation study there is not enough data to determine bioaccumulation potential, however the Epi Suite model predicts low bioaccumulation potential, therefore the substance does not meet the B or vB criteria.
Toxicity:
The acute Daphnia and acute fish study do not warrant classification according to CLP or GHS. The algae study illustrated that the EC50 (growth rate) = 0.79 mg/L, EC50 (yield) = 0.42 mg/L and a NOEL = 0.25 mg/L which does warrant a classification, however this still doesn’t meet the T criterion (NOEC or EC10 < 0.01 mg/L).
Based on the data available, the substance is not/not likely to be a carcinogen, mutagen, reproductively toxic or have a STOT RE classification. There is no other data demonstrating chronic toxicity according to Regulation EC No 1272/2008.
The substance does not meet any of toxicity criteria and is therefore not considered T.
Referenceopen allclose all
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