Ammonium iron(III) citrate

PBT assessment

PBT assessment: overall result

Reference

Name:

ammonium iron(III) citrate

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

ammonium iron(III) citrate

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Ferric ammonium citrate for effects in the environment:

 

The chemical Ferric ammonium citrate (CAS no. 1185-57-5) is used in photography, blueprintsand as veterinary treatment for iron deficiency anaemia. It is also used as iron additives in food for human consumption and for the treatment of iron deficiency in small animals and cattle. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forFerric ammonium citrate. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

Persistence assessment

The tested substance does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Estimation Programs Interface Suite was run to predict the biodegradation potential of the test chemical Ferric ammonium citrate (CAS no. 1185-57-5) in the presence of mixed populations of environmental microorganisms. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that chemicalFerric ammonium citrate was expected to be readily biodegradable.

 

Experimental results from the read across substances also indicate that they are readily biodegradable.

 

Thus, based on the available information, it indicates that chemical Ferric ammonium citrate can beexpected to be readily biodegradablein water and thus likely to be not persistent (not P) in nature.

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

Theoctanol water partition coefficient of the test chemical using modelling database was evaluated to be ranges from -1.66 to -0.737, respectively, which is less than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

On the basis of the various experimental studies ofshort term eco-toxicity data for fish, aquatic invertebrates and aq. algaeof the structurally and functionally similar read across chemical and applying the weight of evidence approach, the LC50/EC50 value was determined to be in the range > 100 to 116.2 mg/l. These value suggest that the substance is not likely to be hazardous to aquatic organisms at environmentally relevant concentration and thus considered to be ‘not classified’ as per the CLP classification criteria.

 

There are no available long-term toxicity evaluations forFerric ammonium citrate. By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

 

The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.