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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
Reference substance:
Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol.
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence Assessment

Manometric respirometry tests (OECD 301F) and other OECD 301 studies showed that this substance is ready biodegradable. Therefore, this substance can be regarded as not persistent.

Bioaccumulation Assessment

No experimental data are available for bioaccumulation of this substance. The calculated BCF value is 1.4 l/kg (Lyman, 1982). On the basis of the calculated BCF value and the log10 Pow -1.07 further testing in the scope of the PBT assessment is not deemed necessary.

Toxicity Assessment

Experimental data on acute toxicity to aquatic organisms are available for this substance. All short-term toxicity EC/LC50 values are much higher than the screening criterion of 0.1 mg/l and the chronic NOEC values are much higher than the screening criterion of 0.01 mg/l. This substance is not classified as being a CMR substance and there is no evidence that this substance is chronically toxic towards mammals. It can therefore be expected that this substance is not toxic towards aquatic organisms.

Conclusion

The overall conclusions, based on the present available data, of the preliminary PBT assessment are that this substance does not meet the PBT screening criteria as outlined in Annex XIII of Directive 2006/121/EC. Further testing in the scope of the final PBT assessment is not required.

Likely routes of exposure:

Because the substance does not fulfill the PBT and vPvB criteria, no emission characterisation is performed.