Iron tris(2-ethylhexanoate)

Endpoint summary

Description of key information

Acute oral toxicity: not classified according to the CLP Regulation (EC) No. 1272/2008

Acute dermal toxicity: not classified according to the CLP Regulation (EC) No. 1272/2008

Acute inhalation toxicity: waived

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute Oral Toxicity

The potential in vitro cytotoxicity of the test item has been evaluated on Balb/c 3T3 cells. Cell cultures were treated with different concentrations of the test item. At the end of treatment time, measurement of neutral red uptake was performed to assess cytotoxicity and cell layers were examined in order to evaluate changes in cell morphology. Test item solutions were prepared using Ethanol.

A preliminary range-finder experiment was undertaken in order to select appropriate dose levels for the Main Assay. Based on the results obtained in a preliminary solubility trial, the test item was assayed at a maximum dose level of 250 µg/mL and at a wide range of lower dose levels: 25.0, 2.50, 0.250, 0.0250, 0.00250, 0.000250 and 0.0000250 µg/mL.

Reduction of the cell layer and change in cell morphology were noted at 250 µg/mL, where slight reduction in neutral red uptake was also observed. However, at this concentration precipitation of the test item was seen.

Since cytotoxicity should be evaluated at dose levels without visible precipitate, the Main Assay was performed using the following concentrations spaced by a factor of 2.5: 125, 50.0, 20.0, 8.00, 3.20, 1.28, 0.512 and 0.205 µg/mL. Precipitation of the test item was observed by the end of treatment at the highest dose level. Slight reduction of cell layer was noted at 50 µg/mL, while reduction of the cell layer and change in cell morphology were noted at 125 µg/mL. At these concentrations mild reduction in neutral red uptake was also observed.

Negative and positive control treatments were included in the Main Assay. Negative control cultures gave acceptable optical density values (0.183 ≤ OD≤ 0.769). Dose related toxicity was observed after treatment with the positive control, with a calculated IC50 value of 45.6 µg/mL, indicating the correct functioning of the assay system.

The test item was not considered to be cytotoxic, under the reported experimental conditions. However, solubility is a limiting factor in achieving sufficient cytotoxicity for the calculation of the IC50 value.

To support this results an evaluation on the information available on different Iron(III) complexes and on the free carboxilic acid has been done.

Based on the data collected starting from this two topics, no hazards have been identified.

Acute Dermal Toxicity

Based on the available information on the acute oral toxicity, no hazard via dermal exposure has been identified.

Acute Inhalation Toxicity

Inhalation exposure to the test item is not likely or expected based on the liquid form of the test item and low vapour pressure, therefore, it was not necessary to perform an acute inhalation toxicity study in order to determine acute toxicity.

Justification for classification or non-classification

The substance is considered exempt from classification for acute oral toxicity according to the CLP Regulation (EC) No. 1272/2008 (Appendix R.7.4–1 of Chapter R.7a: Endpoint Specific Guidance). Detailed documentation for the evaluation of acute oral toxicity using a Weight of Evidence approach is provided in a separate attachment.

The substance is not classified for acute dermal toxicity according to the CLP Regulation (EC) No. 1272/2008.

Further, inhalation exposure to the test item is not likely or expected based on the liquid form of the test item and low vapour pressure, therefore, it was not necessary to perform an acute inhalation toxicity study in order to determine acute toxicity.