Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Ammonium iron(3+) hexakis(cyano-C) ferrate(4-) was examined in a Local Lymph Node Assay in mice according to OECD 429 and GLP (Török-Bathó, 2011). The test substance was diluted with dimethylformamide (DMF) to gain concentrations of 10, 25 and 50% (w/v) that were used in the assay. A preliminiary screening test suggested that these concentrations would not induce systemic toxicity or excessive local irritation. The mice were treated by topical application of the appropriate test concentrations to the dorsal surface of each ear for 3 consecutive days (Days 1-3). On Days 4 and 5, mice were not treated. On Day 6, all mice were injected with³H-methyl thymidine (³HTdR) and sacrificed 5 h afterwards. The draining auricular lymph nodes were excised and pooled for each experimental group. ³HTdR incorporation in lymphocytes was measured by β-scintillation counting. No deaths occurred during the study period and no signs of systemic toxicity or local skin irritation were noted. Stimulation indices (SI) of 1.3, 1.2 and 1.2 were calculated for the test concentrations of 10, 25 and 50%, respectively.

Thus, under the test conditions, the test substance was not considered to be a skin sensitizer, since it did not elicit a SI ≥ 3 in the LLNA.

In addition, there is a second skin sensitisation study, a Guinea Pig Maximisation Test, available for the submission substance (Iron Blue), performed prior to the invention of GLP and adoption of OECD guideline 406, but according to the standards at the time and with only minor deviations from guideline protocols, which serves as supporting study (Cuthbert and McGregor, 1977).

Ten female Dunkin-Hartely guinea pigs were tested. The induction procedure consisted of 3 pairs of intradermal injection of Friend's Adjuvant, the test material alone and the test material in Friend's Adjuvant followed after 7 days by a topical application of the test material. The challenge procedure consisted of a topical application (2% test substance in water), and was carried out 14 days after the completion of the induction procedure. At the challenge stage the test substance did not elicit a positive response in either the test- or control group. Therefore it was concluded that the test substance is not a skin sensitiser in the Guinea Pig Maximisation Test under the conditions of the study.

Migrated from Short description of key information:

Skin sensitization (Local lymph node assay, OECD 429): not sensitizing

Justification for selection of skin sensitisation endpoint:

There are two studies available for ammonium iron(3+) hexakis(cyano-C) ferrate(4-). The selected study is the most adequate and reliable study based on overall assessment of quality.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Migrated from Short description of key information:

No data available.

Justification for classification or non-classification

The available data on skin sensitization of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.