Iron(II) fumarate

PBT assessment

PBT assessment: overall result

Reference

Name:

Iron(II) fumarate

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Iron(II) fumarate

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Ferrous fumarate for effects in the environment:

 

The chemical Ferrous fumarate (CAS no. 141-01-5) is used as a dietary supplement in the treatment of iron deficiency. Also used as iron source in foods and pharmaceuticals; animal feed additive etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Ferrous fumarate. 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

On the basis ofthe various experimental studies ofbiodegradation in waterof the structurally similar test chemical and applying the weight of evidence approach, percentage degradation of test chemical can be expected to be 70 and 87% by BOD and 100% by TOC removal & HPLC parameter in 14 days. Thus, based on percentage degradation, test chemical was evaluated to be readily biodegradable in water.

 

Thus, based on the above available information, it has been concluded Ferrous fumarate is 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:

 

Theestimated BCF value from authoritative database was evaluated to be 4.94 dimensionless and theoctanol water partition coefficient of the test chemical was evaluated to be 0.62, 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

All of the available short-term eco-toxicity data for invertebrates and algae as per OECD TG for the substanceFerrous fumarate,the LC50/EC50 value was determined to be 56.3 mg/l and 56.4 mg/l, respectivelyand on the basis of the various experimental studies of the structurally similar read across chemical and applying the weight of evidence approach,the LC50/EC50 value for fishof the test chemicalcan be expected to be 300 mg/L. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations. Since the test chemical is readily biodegradable in water, chemical was considered as non-toxic to aquatic organisms and hence, considered to be ‘not classified’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for chemical Ferrous fumarate. 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.