Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
5.4 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
5.77 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.54 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
2.1 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.3 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.13 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.29 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

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

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

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

The aquatic toxicity for fish, Daphnia and algae was determined in tests with Water Accommodated Fractions. For algae, the 72h ErL50 = 9.7 mg/L. For Daphnia the 48h-EL50 is 8.9 mg/L. For fish, the 96h-EL50 is > 100 mg/L.

All constituents have the same working mechanism (Narcosis and Polar narcosis) and there are no minor constituents that are highly toxic to the environment. In view of the fate and behaviour and risk assessment Limonene, as the major constituent, can be taken as representative for the other constituents.

 

Mandarin Oil is a complex mixture with limonene as the major constituent. A DPD+ analysis (ref 1) for Mandarin Oil identified D-limonene to represent the dominant risk to the environment (see table). The ratio calculated from the constituent concentration and concentration limit is called Lead Substance Indicator (LSI). Thus the PNEC 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 are publicly available on the ECHA website (CAS no 5989 -27 -5).

 

 

CAS

Substance

Conc. in mandarin oil (%)

R-phrase(s)

Conc. limit

LSI

5989-27-5

D-Limonene

75

R50/53

0.25

300

 

(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 Mandarin oil, the lowest ecotoxicity value is a 48h-EL50 from a Daphnia WAF study. In this study the 48h-EL50 is 8.9 mg/L. This leads to a classification with R51.

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

As over 95% of the constituents of Mandarin oil have an estimated log Kow >4 and no measured data on BCF is available for Mandarin oil, it is also classified as R53.

Thus according to Directive 67/548/EEC Mandarin oil is classified as R51/53 (Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment).

According to Regulation 1272/2008/EC (CLP) Mandarin oil is classified as hazardous to the aquatic environment Chronic Category 2 (H411).