Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating

Eye irritation (OECD 405): not irritating

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/ corrosion:

A possible skin irritation effect of ammonium iron(3+) hexakis(cyano-C) ferrate(4-) was investigated in a study performed according to OECD 404 and GLP (Zelenák, 2011). The powdery test substance was applied by an occlusive patch on the shaved skin of 3 male New Zealand White rabbits for 4 h. After patch removal, the treated skin was cleaned with water.

Edema and erythema formation were assessed 1, 24, 48 and 72 h after removal of the test substance using the Draize scoring system. Very slight erythema and edema formation was observed in one animal at 1 and 24 h post application. The skin reaction was reversible within 48 h. No erythema and/or edema formation was noted in another animal during the observation period. In conclusion, under the test conditions, the test substance was not irritating to the skin.

A second skin irritation study with the submission substance (Iron Blue) is available, performed prior to the invention of GLP and adoption of the guideline but according to the standards at the time and with acceptable deviations from guideline protocols, which serves as supporting study (Cuthbert and McGregor, 1977); the test substance was compared with a standard irritant, 10% aqueous sodium lauryl sulphate. The shaved dorsal skin of New Zealand white rabbits was exposed to 0.5 mL of the test material as a paste in water (30% w/w) for 24 hours under occlusive conditions. After exposure the skin was cleaned from the residual test substance. Skin reactions were assessed according to the Draize scoring system 24 and 72 h after removal of the test substance. Very slight erythema and edema was observed at the reading time point 24 h. Both effects had completely revealed within 72 h.

Eye Irritation:

The eye irritation potential of ammonium iron(3+) hexakis(cyano-C) ferrate(4-) was tested in accordance with OECD 405 and GLP (Tavaszi, 2011b). The powdery test substance was instilled into the left eye of each of three male New Zealand White rabbits. The other eye was not treated and served as control. At the first reading time point 1 h after instillation, the residual test substance was rinsed with physiological saline solution. The grades of ocular reaction (conjunctivae redness, conjunctivae chemosis, cornea, iris) were assessed 1, 24, 48 and 72 h after instillation of the test substance.

Very slight conjunctivae redness (score 1) was noted in all animals 1 h after instillation of the test substance. At the 24 h reading time point, very slight conjunctivae redness (score 1) was still observed in 2/3 animals. The effect was reversible in all animals within 48 h. At the 1 h reading time point, very slight chemosis (score 1) was observed in 1/3 animals and very slight corneal opacity (score 1) was noted in 2/3 animals. Both effects were reversible within 24 h. No effect on the iris of any animal was observed at any time point. In conclusion, under the test conditions, the test substance was not irritating to the eyes.

There is a second eye irritation study available for the submission substance (Iron Blue), performed prior to the invention of GLP and adoption of the guideline, but according to the standards at the time and with acceptable deviations from guideline protocols, which serves as supporting study (Cuthbert and McGregor, 1977). A single sample of 50 mg of the test substance was instilled into one eye of three male and three female Albino rabbits. Observations were made 24, 48, 72 hours and 7 days after instillation. Eye reactions were assessed according to the Draize scoring system. The test substance was concluded not to be an eye irritant.

Justification for selection of skin irritation / corrosion 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.

Justification for selection of eye irritation 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.

Justification for classification or non-classification

The available data on skin and eye irritation 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.

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