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

Endpoint summary

Description of key information

Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off limit)

Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw

No acute inhalation toxicity studies are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is GLP compliant and has Klimisch score 1.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is GLP compliant and has Klimisch score 1.

Additional information

The key study for acute oral toxicity was performed according to the acute toxic class method (OECD 423) and GLP (Tavaszi, 2011). First, 3 female Wistar rats received 300 mg/kg bw of ammonium iron(3+) hexakis(cyano-C) ferrate(4-) by gavage. As no mortality occurred, a group of 3 female rats was treated with 2000 mg/kg bw of the test substance. Again, there was no mortality. To confirm this finding, another group of 3 female rats was treated with 2000 mg/kg bw of the test substance. All animals survived this treatment. During the 14 d-observation period, no clinical signs and no effects on the body weight were observed in any animal. Macroscopic examinations at necropsy did not reveal any abnormalities.

Thus, the oral LD50 cut-off value for ammonium iron(3+) hexakis(cyano-C)ferrate(4-) is 5000 mg/kg bw in the rat according to the acute toxic class method described in the OECD guideline 423.

Moreover, there is a supporting study on acute oral toxicity with the submission substance available.

The study was performed with Iron Blue (containing ferric ammonium ferrocyanide and aminor impurity of sodium ferric ferrocyanide which is common for the submission substance), a common synonym for the submission substance, according to the current standards at the time and equivalent or similar to OECD Guideline 401 (Cuthbert and McGregor, 1977). Three male Sprague-Dawley rats received a dose of 15000 mg/kg bw Iron Blue in water by oral gavage. The animals were observed for 14 days. All animals survived. No signs of systemic toxicity were observed, but however post mortem examination revealed a slightly darker coloration than normal and a granular appearance in the spleen. Thus, the acute oral LD50 in rats was found to be greater than 15000 mg/kg bw.

A reliable acute dermal study was performed with CAS 25860-00-5 as a limit test according to OECD Guideline 402 (Saitoh, 2010). Ammonium iron (3+) hexakis (cyano-C) ferrate (4-) was administered once percutaneously to 7 male and female Crl:CD(SD) rats each at a dose of 2000 mg/kg bw. In the results, no death occurred in either sex and no test substance-related change was seen in clinical signs, body weight, or necropsy. Therefore, the LD₅₀value of ammonium iron (3+) hexakis (cyano-C) ferrate (4-) was considered to be greater than 2000 mg/kg under the experimental conditions of this study.

Justification for selection of acute toxicity – oral endpoint

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

Justification for selection of acute toxicity – dermal endpoint

Only one study available.

Justification for classification or non-classification

The available data on acute oral and dermal toxicity 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.