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Based on a weight of evidence approach, the toxicity of Eucalyptus oil to aquatic organisms was first estimated with the additivity formula, as recommended in the Regulation (EC) No 1272/2008 (CLP), using adequate toxicity data of major constituents, greater than 10% in the mixture. Three constituents were considered, representing 90% of the mixture. To obtain worst case estimations, the worst case percentages of each constituent were taken into account based on the individual toxicities of these compounds. These data are summarized in the table below:

Constituents

Typical value in the mixture

Acute fish

96h-LC50, mg/L

Aquatic invertebrates

48h-EC50, mg/L

Algae

ErC50, mg/L

Cineol 1,8

55%

57

> 100

> 74

Limonene

12%

0.71

0.307

> 1.6

Pinene α

23%

0.28

0.475

> 0,494

L(E)C50 values (mg/L) estimated for Eucalyptus oil

0.90

1.02

1.64

Constituents

Typical value in the mixture

Algae

NOEC, mg/L

Cineol 1,8

55%

37

Limonene

12%

1.6

Pinene α

23%

0.247

NOEC value (mg/L) estimated for Eucalyptus oil

0.88

Based on individual toxicities of the major constituents, the L(E) C50 values for Eucalyptus oil were estimated to be 0.90 mg/L for fish, 1.02 mg/L for aquatic invertebrates and 1.64 mg/L for algae, and the NOEC value for Eucalyptus oil was estimated to be 0.88 mg/L for algae (based on growth rate).

Considering these results, Eucalyptus oil should be classified as Aquatic Acute 1 and Aquatic Chronic 3, according to the 2nd ATP of the Regulation (EC) No 1272/2008.

However, this constituent approach was considered as a worst case and finally not realistic. To prove that Eucalyptus oil is not classified as Aquatic Acute 1 and as fish was considered as the most sensitive species in acute conditions, two experimental acute fish studies were performed for two worst case typical mixtures of Eucalyptus oil (one mixture containing the greater percentage of Limonene: Eucalyptus crude oil, and the other the greater percentage of alpha-pinene: Eucalyptus oil globulus).

As a validation that additivity approach is a real worst case, the experimental studies show 96h-LL50 of 18mg/L and 42 mg/L for both Eucalyptus crude oil and Eucalyptus oil globulus respectively. Therefore, the Aquatic Acute 1 classification should no longer be considered but the Aquatic Chronic 2 classification should be taken into account (based on estimated toxicity for aquatic invertebrates).

In accordance with column 2 of REACH annex IX, further testing on the long-term effects on aquatic organisms does not need to be conducted as the chemical safety assessment does not indicate a need for further investigation.