Ferric ammonium citrate

Endpoint summary

Description of key information

No information was available on the irritation potential of the reaction mass of ammonium iron (III) citrate and ammonium sulfate. The key information is therefore read across from trisodium citrate and iron sulfate. The key studies, for both skin and eye irritation of trisodium citrate were conducted according to current OECD guideline and in compliance with GLP, and they found the substance not irritating (Roche, 1995a, 1995b).

In the key study (Clouzeau, 1994), iron sulfate was irritating to the skin of two of three New Zealand white rabbits, and it is concluded that the substance is irritating to the skin. In the case of eye irritation, a reliable study (Johnson, 2003) suggest that a weak solution is not irritating. However, based on the weight of evidence across the iron salts category, it is concluded that this substance may be irritating to the eyes.  

Additional information

Reliable data on skin and eye irritation were available for trisodium citrate and iron sulfate, which were used to fill the irritation endpoints for reaction mass of ammonium iron (III) citrate and ammonium sulfate. The original studies were considered reliability 1. Read across to the registered substance is considered scientifically justified and is reliability 2.

Both the registered substance and the read across substance (trisodium citrate) contain citrate ions, and the read across substance has been selected based on the analogy of trisodium citrate to the registered substance in that the counterpart ion is bound to citrate. Sodium citrate will dissociate freely, whereas ferric citrate will not and it therefore represents the worst case scenario of potential irritation from citric acid.

The data read across from iron sulfate presents results with irritant effects on the skin (Clouzeau 1994) but not the eye (Johnson 2003). Based on the evidence across the iron salts category (OECD SIAR 2008) and an approach weighing on the side of caution, the reaction mass of iron ammonium (III) citrate and ammonium sulfate is belived to have the potential to have irritant effects on the skin and eye.

The other non-citrate chemical species that are part of the registered substance are ammonium and ammonium sulfate for which no data are included in the present data set, however a disseminated REACH dossier for ammonium sulfate is available via the ECHA website which includes confidential company data as key studies for the irritation endpoints. For skin irritation, slight erythema is reported in rabbits after a 24 hour occlusive exposure to the test material which was fully reversible within 8 days. For eye irritation, a single instillation of undiluted test material into the eyes of rabbits resulted in slight redness at 24 hours with no detectable effects by day 8. Both studies conclude ammonium sulfate to be not irritating. The ammonium and ammonium sulfate are therefore not expected to contribute to the irritation potential of the registered substance.

OECD SIAR 2008. SIDS Initial Assessment Report for SIAM 24, Paris, 2007. Chemical Category: Iron Salts. Sponsor Country: Finland. Industry sponsor/consortium: CEFIC Incopa Iron Salts Group. July 2007, published online 2008.

Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the potential of ferric salts to cause irritation it is proposed that the reaction mass of iron ammonium (III) citrate and ammonium sulfate is labelled according to regulation 1272/2008 as 'Category 2: Irritant' for eyes and skin, and hence 'H315: Causes skin irritation'

and 'H319: Causes serious eye irritation'.