Spinflam MF 83 PP-25

Endpoint summary

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

FURTHER INFORMATION: review of existing data

In order to exclude any reason of concern, the literature data available about aquatic toxicity of the main components of the UVCB is reported.

 

PIPERAZINE

In an in vivo study performed on pigs, piperazine is readily absorbed from the gastrointestinal tract. The major part of the resorbed compound is excreted as unchanged piperazine during the first 48 hours. An oral absorption of 100 % is brought forward to the exposure assessment. However, no data on dermal or respiratory uptake have been located. Default absorption values of 100 % are assumed for dermal and inhalation exposure.

The principal route of excretion of piperazine and its metabolites is via urine, with a minor fraction recovered from faeces (16 %). However, about one forth of a single administered oral dose is retained in the tissues after 7 days, some of which seems to consist of unidentified conversion products. Besides N-mononitrosopiperazine, no other metabolites have been identified.

In humans the kinetics of the uptake and excretion of piperazine and its metabolites with urine appear to be roughly similar to that in the pig, although the nature and extent of conversion to metabolites remains unknown. In the presence of nitrite, the in vivo formation of small amounts of nitrosated products from piperazine has been demonstrated to occur in the gastrointestinal tract of experimental animals as well as in humans [European Chemicals Bureau, 2005].

 

MELAMINE

Melamine is absorbed from the GI-tract and rapidly excreted from the body with little or no metabolism with short half life (4-5hours) in the rat and rhesus monkey. No significant accumulation of melamine in tissues is expected and levels in tissues are likely to be similar to plasma levels. Transfer of melamine from feed to pig muscle meat, liver and kidney is approximately 2 % (calculated as the ratio of concentration in tissues and in feed), but is very dependent on the time of sampling due to the rapid elimination resulting in lower transfer rates. Melamine is transferred to cow’s milk with a worst-case estimate of 2 % of the daily dose. The highest estimated transfer factor for chicken meat and kidney would amount to 0.6 and up to 2.6 % respectively. Experimental studies with laying hens, which were given feed contaminated with melamine demonstrated transfer rates from feed to eggs varying between 1.5 and 3.2 %.

Exposure to melamine results in formation of crystals in the urinary tract, consisting of complexes of melamine with substances such as uric acid that occur naturally in urine, or with cyanuric acid if co-exposure occurs. Formation of these complexes is highly dependent on the concentration of melamine and on the composition of the urine (e.g. pH, uric acid, protein). Co-precipitation of melamine with uric acid is more likely to occur in humans because they excrete more uric acid in the urine than most mammals due to a lack of the enzyme urate oxidase. In neonates, the excretion of uric acid in the urine is higher than in adults. In addition, the urinary pH is lower in humans than that of rodents, increasing the likelihood of the formation of insoluble complexes between melamine and uric acid [EFSA, 2010].

Melamine is not metabolized and is rapidly eliminated via urine in a study with oral application to rats. The elimination half-life in plasma is about 3 hours [OECD SIDS, 1998].

 

PHOSPHATES

Phosphates and Polyphosphates toxicity data and metabolism have been reviewed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1982). Various studies tend to indicate that polyphosphates are not absorbed as such in the intestinal tract, but they can be hydrolysed in vivo by enzymes with the formation of monophosphates, mainly orthophosphate and possibly pyrophosphate, which are then absorbed. This is further supported by the fact that systemic effects of polyphosphates are very similar to those of orthophosphates. It was estimated that approximately two-thirds of ingested phosphates is absorbed from the gastro-intestinal tract. No data have been identified with regard to dermal absorption properties. It is generally considered that the percutaneous absorption of salts or ionic substances is limited [HERA, 2003].

 

MELAMINE POLYPHOSPHATE

No toxicokinetic data located for melamine polyphosphate or polyphosphoric acid; limited data for melamine indicate an elimination phase half-life of 2.7 hours from plasma and 3.0 hours for urine [EPA, 2014].

 

PIPERAZINE PYROPHOSPHATE

No toxicokinetic data were located for the substituted amine phosphate mixture. The substituted amine phosphate mixture is estimated to not be absorbed through the skin and absorption is expected through the lung and gastrointestinal (GI) tract. Following absorption, limited data suggest distribution throughout the GI system, liver, and kidney for the substituted amine phosphate and piperazine components. Data for the substituted amine phosphate component indicate an elimination phase half-life of 2.7 hours from plasma and 3 hours for urine. Data for the piperazine component indicate rapid elimination from blood and kidney [EPA, 2014].

Reference

EMEA, 2001. Committee for Veterinary Medicinal Products. EMEA/MRL/771/00-FINAL. Piperazine Summary Report. The European Agency for the Evaluation of Medicinal Products.

Environmental Protection Agency (EPA) United States. An Alternatives Assessment for the Flame Retardant Decabromodiphenyl Ether (DecaBDE). Final report. January 2014.

European Chemicals Bureau; Joint Research Centre (2005). European Union Risk Assessment Report. Piperazine CAS 110-85-0 EC: 203-808-3. 3rd Priority List Volume: 56. Office for Official Publications of the European Communities, 2005.

European Food Safety Authority (EFSA), 2010. Scientific Opinion on Melamine in Food and Feed. EFSA Panel on Contaminants in the Food Chain (CONTAM) and EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). European Food Safety Authority (EFSA), Parma, Italy. EFSA Journal 2010; 8(4):1573.

Human & Environmental Risk Assessment (HERA) on ingredients of European household cleaning products. Sodium Tripolyphosphate (STPP) CAS: 7758-29-4. Draft, June 2003.

JECFA (1982) 26th report of the Joint FAO/WHO Expert Committee on Food Additives, series No.17, p151.

OECD SIDS, 1998. Melamine CAS N°: 108-78-1. UNEP Publications.