Reaction mass of 3,7-dimethyl-1-octyl propionate and citronellyl propionate

Endpoint summary

Description of key information

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 irritation

An in vitro skin irritation test according to OECD guideline 439 and in accordance with GLP principles was performed. The test item was applied undiluted (25 μL), directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42-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. Skin irritation is expressed as the remaining cell viability after exposure to the test item. In the first experiment, the relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 82% (117%, 117% and 12%). Since the mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment it is considered to be non-irritant. However, since the viabilities were spread over two categories the test was repeated. In this first experiment, the standard deviation value of the percentage viability of three tissues treated with the negative or positive control was ≤ 4.4%, indicating that the test system functioned properly. The standard deviation value of the percentage viability of three tissues treated with the test item was 61% which is above the maximum of 18%, which was another reason to repeat the test. In the second experiment, the relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 45% (21%, 39% and 76%). The relative tissue viabilities for the test item were again spread over two categories. The standard deviation value of the percentage viability of three tissues treated with the negative or positive control was ≤ 9.1%. The standard deviation value of the percentage viability of three tissues treated with the test item was 28%, this being > 18% too. Therefore, a third experiment was performed. In the third experiment, the relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 126% (128%, 128% and 123%). Since the mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment the test item is considered to be non-irritant. The positive control had a mean cell viability of 3.7%, 8.7% and 6.7% (experiment 1, 2 and 3 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 in all three experiments. In the third and final experiment, the standard deviation value of the percentage viability of three tissues treated identically was ≤ 2.8%, indicating that the test system functioned properly. In conclusion, the substance does not cause skin irritation in the in vitro skin irritation test.

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. Slight corneal swelling change (mean = -5.5%) was observed during the four-hour observation period on test item treated eyes. No significant cornea opacity change (severity 0.5 on three eyes) was observed. No significant fluorescein retention change (severity 0.5 on two eyes and no fluorescein retention change on one eye) was noted. 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 endpoints Corneal swelling was assigned ICE CLASS II and the Corneal opacity 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.

Justification for classification or non-classification

The substance does not have to be classified for Skin irritation according to EU CLP (EC No. 1272/2008 and its amendments)

The substance does not have to be classified for Eye irritation according to EU CLP (EC No. 1272/2008 and its amendments)