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Administrative data

Description of key information

The study does not need to be conducted because the substance is classified as skin corrosion (Category 1B/1C). The classification of the substance is based on the available data for LD50 or classification of the constituents of the UVCB substance according to Guidance on the Application of CLP Criteria – Guidance to regulation (EC) No 1272/2008 ECHA.

The calculated value of ATEmix according to the formula in Section 3.1.3.6.1 of Annex I to Regulation (EC) No 1272/2008 is 680,272.

The Summer savory oil has 11 known constituents.

The Acute oral toxicity of the oil is calculated on the basis of the available data about LD50 of 2 constituents (Carvacrol, alpha-Terpinene) and the self-classification of 2 other constituents (alpha-Pinene, alpha-Thujene). One constituent (Dipentene/ Limonene) has harmonized classification and it is not classified as acute oral toxicity. Other 6 constituents are with high LD50 values (above 2000 mg/kg bw), they are not classified as acutely toxic via oral route and therefore their LD50 are not taken into account in the calculation.

On the basis of the available data on constituents and the criteria for classifying mixtures according to the Regulation (EC) No 1272/2008, the Summer Savory oil is classified as Acute Toxicity (oral) category 4, H302 Harmful if swallowed.

 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

The Summer Savory oil is classified as Acutely Toxic via oral route, category 4, H302 Harmful if swallowed.

Justification for classification or non-classification

The study does not need to be conducted because the substance is classified as skin corrosion (Category 1B/1C).

The classification of the substance is based on the available data for LD50 or classification of the constituents of the UVCB substance. The classification was calculated using the method in Section 3.1.3.6.2.1.of Annex I of Regulation (EC) No 1272/2008 and Section 3.1.3.3.5. of the Guidance on the Application of CLP Criteria – Guidance to regulation (EC) No 1272/2008 of ECHA, Version 5.0 –July 2017.

The calculated value of ATEmix according to the formula in Section 3.1.3.6.1 of Annex I to Regulation (EC) No 1272/2008 is 680,272.

The Summer savory oil has 11 known constituents.

The Acute oral toxicity of the oil is calculated on the basis of the available data about LD50 of 2 constituents (Carvacrol, alpha-Terpinene) and the self-classification of 2 other constituents (alpha-Pinene, alpha-Thujene). One constituent (Dipentene/ Limonene) has harmonized classification and it is not classified as acute oral toxicity. Other 6 constituents with LD50 values above 2000 mg/kg bw are not classified as acutely toxic via oral route and therefore their LD50 are not taken into account in the calculation.

On the basis of the available data on constituents and the criteria for classifying mixtures according to the Regulation (EC) No 1272/2008, the Summer Savory oil is classified as Acute Toxicity (oral) category 4, H302 Harmful if swallowed.