Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Justification for type of 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 substance according to Guidance on the Application of CLP Criteria – Guidance to regulation (EC) No 1272/2008 ECHA.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity
Author:
Jenner P.M., E.C.Hagan, J.M.Taylor, E.L.Cook andO.G. Fitzhugh
Year:
1964
Bibliographic source:
Food Cosmet. Toxicol. Vol. 2, 327-343
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test material

Specific details on test material used for the study:
Not specified

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
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.
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.
Executive summary:

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.