Amines, bis(C11-14-branched and linear alkyl), O,O-di-iso-Pr phosphorodithioates

Endpoint summary

Description of key information

In in-vitro experiments it was shown that the test substance has a potential for skin irritation but was not corrosive to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

EpiDerm™ skin irritation/corrosion test

In a GLP compliant in vitro test according to OECD guidelines 431 and 439 (BASF, 61V0590/11A387, 2012) the test article's potential to cause dermal corrosion/irritation was assessed by a single topical application of 50 μL (corrosion test) or 30 μL (irritation test) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by an about 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. In this experiment, the test substance was found to reduce MTT directly. Therefore an additional MTT reduction control was introduced (performed with the corrosion test, only). In the corrosion test, the mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 77%, and it was 84% after an exposure period of 1 hour. In the irritation test, the mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 12%. Based on the observed results it was concluded, that the test article showed a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen.

Bovine Corneal Opacity and Permeability Test (BCOP Test)

In a GLP-compliant in vitro test according to OECD guideline 437, the test article’s potential to cause serious damage to the eyes was assessed by a single topical application of 750 μL of the undiluted test substance to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance for 10 minutes followed by a 2-hour post-incubation period. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an in vitroIrritancy Score of the test substance relative to the control corneas. The calculated in vitro irritancy score for the test substance was 2.5. Based on the observed results and applying the evaluation criteria it was concluded, that the test substance does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. However, it has to be noted that the test method does not yet allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance.

Effects on skin irritation/corrosion: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

An in vitro skin irritation test showed that the test item has the potential to cause skin irritation. Therefore, the test item is classified for skin irritation in accordance with Directive 67/548/EEC and Regulation (EC) No 1272/2008.

In an in vitro eye corrosion test the item was shown to be not corrosive/highly irritating to the eye. However, the data obtained in this study is insufficient for an ultimate classification of the test item with regard to eye irritation.