Registration Dossier
Registration Dossier
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EC number: 271-692-1 | CAS number: 68604-41-1 The complex residuum from the distillation of the methyl ester of C16-18 and C18-unsatd. fatty acids. It consists primarily of trialkyl glycerides and undistilled methyl ester of the fatty acids.
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues boundary
- Type of composition:
- boundary composition of the substance
- State / form:
- other: semisolid
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues boundary
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues boundary
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues boundary
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues boundary
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues boundary
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues boundary
- Name:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues LEGALLY
- Type of composition:
- legal entity composition of the substance
- State / form:
- other: semisolid
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues LEGALLY
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues LEGALLY
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues LEGALLY
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues LEGALLY
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues LEGALLY
- Reference substance:
- Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues LEGALLY
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Both compositions have the same non-PBT outcome.
Based on the assessment described in the subsections below the submission substance is not considered as PBT / vPvB.
Persistence assessment
Screening criteria
Screening test
Test results / Justification
Ready biodegradability test(s)
The assessed substance is readily biodegradable indicating that the substance is not a P/vP.
The assessed substance is readily biodegradable indicating that the substance is not a P/vP.
Bioaccumulation assessment
Criteria based on Annex XIII of REACH
Criterion for non-B
Test results / Justification
BCF <= 2000 L/kg
The available BCF data indicate that the assessed substance is not a B.
Conclusion of B / vB assessment
The constituent of methyl esters distillation residue are also monoglyceride, diglyceride and trygliceride. These substances are included in fish and mammalian natural diet. They follow the normal fat metabolism and may be accumulated in adipose tissue inside the organism when quantities exceed the natural regulation capacity metabolism. The other constituents (fatty acid methyl esters and glycerine) doesn't present any concern related to bioaccumulation.
Toxicity assessment
Criteria based on Annex XIII of REACH
Criterion for non-T
Test results / Justification
NOEC >= 0.01 mg/L for marine or freshwater organisms (long-term toxicity)
No long term ecotox studies are available. Based on the available acute toxicity studies, all values are above 1 mg/L.
Substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3)
From the existing studies no concern is arised for carcinogenic effect:
1) The substance is not mutagenic.The ability of substances to induce mutations or genotoxicity can be indicative of carcinogenic potential. There is, in general, a good correlation between positive genotoxicity findings in vivo and animal carcinogenicity bioassay results
2) Repeated dose toxicity tests: no toxicity has been revealed in repeated dose toxicity tests, no tissued has revealed preneoplastic
changes (e.g. hyperplasia or metaplasia) suspected to be conducive to tumour development
3) Toxicokinetics : no tissue has been identified as a targets for toxicity and development of tumors
4) QSAR prediction: CAESAR modelling version 1.0.0.6 doesnt show any concern for carcinogenicity potential on the different conponents of the substance (Fatty acids, Fatty acids methyl esters, tryglicerides)
No other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC)
The available information indicates that the assessed substance is not a T.
- Likely routes of exposure:
not other available informations
Referenceopen allclose all
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