Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
Fatty acids, C18-unsatd., dimers, oligomeric reaction products with 1-chloro-2,3-epoxypropane
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
further information relevant for the PBT assessment is necessary
Justification:

Persistence

The test substance is not readily biodegradable therefore therefore on the basis of the screening criteria it must be considered that the substance could possess P or vP properties, although no data are currently available to confirm this conclusion.

Bioaccumulation

Experimentally derived Log Kow was found to be 6.5 therefore on the basis of the screening criteria it must be considered that the substance could possess B or vB properties, although no data are currently available to confirm this conclusion.

Toxicity

For aquatic toxicity long term toxicity data not available. No toxicity was observed at all trophic levels for short term aquatic studies.

No available data for carcinogenicity.

Mutagenicity classification remains inconclusive a testing proposal for an in-vivo study has been included under section 7.6.2.

Adverse effects were seen in the reproductive developmental screening study therefore the test substance is classified Toxic to reproduction Category 1B.

The test substance is not classified for specific target organ toxicity after repeated exposure. Effects were only seen in reproductive organs therefore classified for reproductive toxicity only. Based on the reproductive toxicity classification it can be confirmed the substance is toxic.

Conclusion

The overall PBT assessment cannot be concluded as only the Toxicity data are sufficient to conclude the toxicity criteria. Persistence and Bioaccumulation criteria cannot be concluded based on screening criteria therefore further information is necessary to finalise the PBT status. We will update the dossier as soon further information information becomes available on the Persistence and Bioaccumulation endpoints.