Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

All constituents in Tangerine Oil 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.

 

Tangerine Oil is a complex mixture with limonene as the major constituent. A DPD+ analysis (ref 1) for Tangerine Oil identified 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 limonene will be used for the risk characterization and the exposure assessment will also be carried out using limonene. PNEC values for limonene are publicly available on the ECHA website (CAS no 5989 -27 -5).

 

 CAS

Substance

Conc. in Tangerine oil (%)

R-phrase(s)

Conc. limit

LSI

5989-27-5

Limonene

88

R50/53

0.25

352

 

(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

Tangerine Oil is a Natural Complex Substance, a mixture consisting of slightly soluble to soluble constituents. The toxicity of this NCS on algae, daphnia and fish were not experimentally established. For these endpoints read-across was conducted to the citrus oils group. Reliable data are available for Orange Oil, Mandarin oil and Lime oil. The justification of this read-across is described in detail in the read-across justification document.

Short-term toxicity tests for all three trophic levels are available. For daphnia and algae, the EL50 and ErL50 were 1.1 and 8.0 mg/L, respectively. While the derived 96h-LL50 for fish was 5.65 mg/L. Based on the lowest acute value, in this case daphnia, the substance does not need to be classified for acute aquatic toxicity according to Table 4.1.0 (a) of CLP.

As only one reliable long-term toxicity endpoint is available (ErL10 of 5.1 mg/L) chronic classification needs to be derived on both acute and chronic data, and the worst case should be taken. Based on the ErL10 value, the substance does not need to be classified for chronic toxicity. The substance is readily biodegradable, however has a log Kow ranging 3.38 - 4.88 and the lowest acute toxicity value is 1.1 mg/L for daphnia which, on the basis of constituents with log Kow > 4, would lead to classification Aquatic Chronic 2 (H411).

Based on the available aquatic toxicity studies, Tangerine oil needs to be classified for the environment as Aquatic Chronic 2 (H411) according to EU CLP (EC 1272/2008) and its amendments. M factor for acute and chronic toxicity are not applicable.