Iron tris(2-ethylhexanoate)

Endpoint summary

Description of key information

Not eye irritant

Not skin irritant

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

Eye Irritation/Corrosion

The eye irritation potential of the test substance has been investigated according to the OECD guideline 492.

As the test item showed intense coloring in the pre-test, there was the risk to influence the photometric measurement. Therefore an additional test for intensely coloured test items was performed.

The viscous non-pipettable test item was treated as solid and therefore it was applied topically to a three-dimensional RhCE tissue construct in duplicate for an exposure time of 6 hours.

After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution.

Demineralised water was used as negative control and methyl acetate was used as positive control.

The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD>0.8 and < 2.5, OD was 2.0. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 38.2 % (< 50%).

Variation within tissue replicates of the controls and the test item was acceptable (< 20%).

After treatment with the test item, the mean value of relative tissue viability was 77.8 %.

Skin Irritation/Corrosion

The test substance has been first test for its potential to cause eye irritation according to the method above described. Due to the results obtained in the study conducted following OECD guideline 492, no further studies on skin irritation/corrosion have been taken into account and the substance is considered as non skin irritant.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application. The classification system for substances involves a tiered testing and evaluation scheme, combining pre-existing information on serious ocular tissue damage and on eye irritation as well as considerations on (Q)SAR and the output of validated in vitro tests in order to avoid unnecessary animal testing.

The OECD has at present adopted five in vitro test guidelines for assessing eye hazard potential. These tests are recommended for use as part of a tiered-testing strategy for regulatory classification and labelling.

Test method OECD TG 492 – Reconstructed human Cornea-like Epithelium Test Method (RhCE) is an in vitro assay that may be used to identify chemicals not requiring classification and labelling for eye irritation or serious eye damage. The only in vitro test method currently covered by this Test Guideline is the EpiOcular™ Eye Irritation Test (EIT). The percentage tissue viability cut-off value for identifying test chemicals not requiring classification for eye irritation or serious eye damage (UN GHS No Category) is > 60 %.

Based on the results obtained in the RhCE test performed on the substance, the mean value of tissue viability was 106.9 %. This value is above the threshold for eye irritation potential (60 %). Thus, the substance is not considered as eye irritant according to the CLP Regulation (EC 1272/2008).

No studies have been carried out to assess the skin irritation however, cosidering the results obtained in the eye irritation in vitro study, the substance is not classified as skin irritant.