Bergamot, ext.

Ecotoxicological Summary

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Bergamot oil is a natural complex substance consisting of a mixture of slightly soluble to soluble constituents.

For Bergamot oil, key WAF (Water Accommodated Fractions) studies on the aquatic toxicity are available for fish, daphnia and algae.

For algae, the 72h ErL50 = 31 mg/L. For Daphnia the 48h-EL50 is 33 mg/L. For fish, the 96h-EL50 is 18 mg/L

For one quality, Bergamot oil cold pressed, additional toxicity was calculated due to the presence of the constituent Bergamottin, which was not present in the tested Bergamot oil quality. In order to cover for the potential additional toxicity, read across was conducted to Lime oil cold pressed. The lowest value was an 72h ErL50 of 11 mg/L with algae. This read across is added in this dossier. See for the justification the attached Read across justification document.

All constituents have the same working mechanism (Narcosis and Polar narcosis). In view of the fate and behaviour and risk assessment D-limonene, as the major constituent, can be taken as representative for the substance.

 

Bergamot Oil is a complex mixture with D-limonene as the major constituent. A DPD+ analysis (ref 1) for Bergamot Oil identified D-limonene to represent the dominant risk to the environment. The ratio calculated from the constituent concentration and concentration limit is called Lead Substance Indicator (LSI). Thus, as D-limonene was identified as the lead constituent for the environmental risk assessment, the PNECs for D-limonene will be used for the risk characterization and the exposure assessment will also be carried out using D-limonene. PNEC values for D-limonene (CAS 5989-27-5) are publicly available on the ECHA website.

(1) REACH: Exposure scenarios for preparations. Methodology for the identification of substances that represent the dominant risks to human health and/or the environment and the drivers for risk management measures, CEFIC, June 09: final for publication.

Conclusion on classification

For Bergamot oil, the lowest ecotoxicity value is a 96h-EL50 from a Fish WAF study. In this study the 96h-EL50 is 18 mg/L. For one Bergamot oil quality read across is conducted: This leads to a 72h-ErL50 of 11 mg/L with algae.

The test substance Bergamot oil was shown to be readily biodegradable.

As 84.55% of the constituents of Bergamot oil have an estimated log Kow >4 and no measured data on BCF is available for Bergamot oil, Bergamot oil is to be considered as hazardous to the aquatic environment and classified with Chronic Category 3 (H412) according to Regulation 1272/2008/EC (CLP).