Registration Dossier
Registration Dossier
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EC number: 947-785-4 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- Reference substance:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- Reference substance:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- Name:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- Reference substance:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- Reference substance:
- Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is an UVCB substance. Due to its complex composition, methods for the experimental measurement of octanol-water partition coefficient (Kow) of fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine are technically not applicable. On the basis of the high solubility in water (fully miscible in the range of 5 - 95% by weight) and the chemical nature, log Kow value for the substance is expected to be low. Estimated Log Kow value for the main constituents have been derived using KOWWIN (v.1.68, September 2010; US EPA) and were for the three main components -1.56, 1.2 and 4.72, respectively. Considering the ratios of components this results in a weighted value for log Pow of 1.74, rounded up conservatively to 2, which is the value used for hazard and risk assessment. The log Pow value conservatively estimated (~2) is in good alignment with the observation of the substance being fully miscible in water and thus the substance is not expected to bioaccumulate. This is supported by the lack of systemic toxicity seen in the OECD 422 study.
The substance is not readily biodegradable and a conclusion on persistence cannot be made based on data currently available at this tonnage band. Further studies would be needed to derive a conclusion, but in lack of bioaccumulation potential such studies are not warranted, currently.
The substance has shown no toxicity towards aquatic organisms (fish, daphnia, algae) and microorganisms in sewage treatment sludge. Furthermore mutagenicity data from in vitro studies were negative and no reproductive toxicity was seen in an OECD 422 study; thus, the substance is not considered a CMR. Also, no systemic long-term toxicity was seen and in conclusion the T-criterion in REACH Annex XIII is not fulfilled.
In conclusion, the substance is neither considered PBT nor vPvB.
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