Reaction mass of citronellyl propionate and geranyl propionate and neryl propionate

Endpoint summary

Description of key information

Skin corrosion: Not corrosive based on absence of irritating effects in an OECD TG 402 test.

Skin irritation: 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:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin corrosion

The acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level of 2 000 mg/kg body weight.

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. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 49%. 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 (16%, 16% and 117%) 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 29% (individual viabilities of 21%, 48% and 19%). Since the treated tissues had an individual cell viability after exposure to the test item below 50% and the mean relative tissue viability for the test item in the repeat experiment was well below 50% after 15 ± 0.5 minutes treatment, the test item is considered to be irritant. The positive control had a mean cell viability of 3.7% and 5.2% (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 was ≤ 16%, 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 59%. Therefore, the repeat experiment was performed. In conclusion, the test substance causes 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. No significant corneal swelling change (mean = -3.1%) was observed during the four-hour observation period on test item treated eyes. No significant cornea opacity change was observed (mean = 0.33) during the four-hour observation period on test item treated eyes. No significant fluorescein retention change (mean = 0.17) was observed on test item treated eyes during the observation period. No 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 opacity, Corneal swelling and Fluorescein retention endpoints were assigned ICE CLASS I. According to the OECD/GHS classification scheme the substance is a non irritant.

Justification for classification or non-classification

The substance has to be classified as Skin irritant and shall be labelled with H315: Causes 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)