Reaction mass of ethoxylated N-oleyl-1,3-propanediamine, hydrofluorides of and ethoxylated N-palmityl-1,3-propanediamine, hydrofluorides of and ethoxylated N-stearyl-1,3-propanediamine, hydrofluorides of and olaflur

Endpoint summary

Description of key information

Olaflur is considered as local irritant by contact with skin and eyes based on the results obtained by in vitro testing.

Corrosive potential was not shown. Due to the weight of evidence of these in vitro data additional in vivo testing is not required.

 

 

 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

In vitro Skin Corrosion: Human Skin Model Test

Two tissues of the human skin model EpiDermTM were treated with Olaflur for three minutes and one hour, respectively. 25 mg of the wax-like test item were applied to each tissue, wetted with H2O and spread to match the tissue size. Deionised water was used as negative control, 8-m KOH was used as positive control. After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were increased to 100.3 %. This value is well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were reduced to 90.7 %. This value, too, is well above the threshold for corrosion potential (15%). Therefore, Olaflur is considered as not corrosive in the Human Skin Model Test.

In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method

The test item Olaflur is considered as irritant in the human skin model in vitro. After the treatment, the relative absorbance values were decreased to 16.9%. This value is well below the threshold for irritation (50%). Although the required amount of test item could not be weighed exactly due to the wax-like appearance of the substance, a correlation between used amount and measured irritation did not exist. Therefore, this deviation was considered as uncritical concerning the outcome of the study. The optical density of the negative control was well within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 17.1% (required: <= 20%), thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item. For these reasons, the result of the test is considered valid.

Eye Irritation - HET-CAM Test following ICCVAM

For this HET-CAM test, hen’s eggs with an age of nine days were used. The test item Olaflur was brought onto the surface of the CAM of a hen’s egg which had been incubated at 38.3 °C and 58% humidity for nine days. Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the blood vessels under the membrane. Solutions of SDS (1%) and NaOH (0.1N) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The test item Olaflur showed severe effects on the blood vessels of the CAM. The calculated mean irritation score is 17.20. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Olaflur possesses severe irritation potential.

Justification for classification or non-classification

Olaflur is considered as local irritant by contact with skin and highly irritant in contact with eyes based on the results obtained by in vitro testing. Corrosive potential was not shown. Due to the weight of evidence of these in vitro data additional in vivo testing is not required.

Based on these results classification as “harmful” (Xn) and labelling with R41 according to Directive 67/548/EEC (DSD) respectively classification as skin irritant category 2 (H315) and severe eye irritant, category 1 (H318) according to Regulation (EC) No. 1272/2008) (CLP) (GHS) is recommended.