Turmeric Leaf Oil

Endpoint summary

Description of key information

Skin corrosion: Not corrosive based on an OECD TG 431 test.

Skin irritation: Not irritating based on an OECD TG 439 test.

Eye irritation: Not irritating based on an OECD TG 438 test.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Corrosion

In an in vitro skin corrosion test using a human skin model (EpiDerm Skin Model) performed according to OECD TG 431 and GLP principles, the influence of the test substance on the viability of human skin was tested. 50 μL test substance was applied directly on top of 0.6 cm2 cultured skin. The positive control had a mean relative tissue viability of 7.2% after the 1-hour exposure.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤14%, indicating that the test system functioned properly.

Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 97% and 92%, respectively. Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive.

In conclusion, the test substance is not corosive in accordance with EU CLP (EC no 1272/2008 and its amendments).

 

Skin irritation

An in vitro skin irritation study has been executed according to OECD guideline 439 and in accordance with GLP principles. 

The test item was applied undiluted (25 μL) directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 ± 1 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 40%. Since the mean relative tissue viability for the test item was below or equal to 50% after 15 ± 0.5 minutes treatment it is considered to be irritant. However, since the individual viabilities (26%, 27% and 67%) were spread over two categories, the experiment was repeated.
In the repeat experiment, the relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 84% (individual viabilities of 82%, 72% and 98%). Since the mean relative tissue viability for the test item during the repeat experiment was above 50% after 15 ± 0.5 minutes treatment and in total 4 out of 6 skin tissues treated with test item have an individual tissue viability above 50%, the test item is considered to be non-irritant.
The positive control had a mean cell viability of 3.4% and 24% (experiment 1 and 2 respectively) after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically during the two experiments was ≤ 13%, indicating that the test system functioned properly. Except for the three tissues treated with test item in experiment 1, which had a standard deviation of 23%. Therefore, the repeat experiment was performed.

In conclusion, Turmeric Leaf Oil is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.

 

Eye irritation

An Isolated Chicken Eye Test (ICET) was performed with the Substance according to OECD guideline 438 and in accordance with GLP principles. Thirty µL of the Substance was applied to corneas (n=3). After 10 seconds exposure time, the surface of the eyes was rinsed with physiological saline solution. No significant corneal swelling change (mean = 1.2%) was observed during the four-hour observation period on test item treated eyes. Slight cornea opacity change (severity 0.5 on one eye and severity 1 on two eyes) was observed. No significant fluorescein retention change (severity 0.5) was noted on all eyes. No other morphological effect was observed. The negative control and positive control results were within the historical data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Based on the results, the endpoint Corneal opacity was assigned ICE CLASS II and the Corneal swelling and Fluorescein retention endpoints were assigned ICE CLASS I. According to the OECD/GHS classification scheme and the classification scheme of Schutte et al. (2009) the Substance is a non irritant.