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Report on the Health Effects of Selected Pesticide Coformulants

5 Conclusions

5.1 Data availability on the selected coformulants

The results of this project demonstrate that the data availability for the 18 selected coformulants is limited.

Toxicological data are available for 16 of the selected coformulants; however, for many of these coformulants, various end-points have not been examined thoroughly. For two of these coformulants (sodium ligninsulphonate, polyEGDE), relevant data are only available for acute toxicity and irritation. For two other coformulants (1-methyl-1,2-ethanediyl dioleate, CaDBS), no relevant data are available at all.

In conclusion, the hazard assessments of most of the 18 selected coformulants may be hampered by the data gaps identified.

5.2 Toxicological effects of the selected coformulants

The available data on the selected coformulants indicate that coformulants in pesticides are not toxicologically inert ingredients, but that they may possess a range of toxicological effects.

For 13 of the selected coformulants, irritative effects on the eye, the skin, and/or the respiratory tract are identified as the critical effect based on results from animal studies and/or from human experience; however, the severity of the irritative effects is difficult to evaluate as an effect level could only be derived for 3 of these irritative coformulants. Other critical effects identified include sensitisation, neurotoxicity, CNS-depressing effects, nephrotoxicity, haemolytic anaemia, and liver effects. One coformulant is probably a developmental toxicant following exposure at very high concentrations. No mutagenic/genotoxic or carcinogenic substances were identified among the selected coformulants for which these end-points have been examined (15 and 10 coformulants, respectively).

Eight of the 18 selected coformulants are classified for health effects by the EU (3 for acute toxicity, 4 for irritative effects, 1 for sensitisation, and 1 for effects following repeated exposure (neurotoxicity)).

In conclusion, a number of the selected coformulants have serious adverse health effects. This finding is particularly of concern as the data availability is very limited for some of coformulants. Thus, it cannot be excluded that some of the selected coformulants may have additional toxicological effects than the ones identifiable on the available database.

However, it should be born in mind that it is not possible based exclusively on the results obtained in this project to evaluate whether exposures to any of the 18 selected coformulants in pesticides may constitute a risk for humans of experiencing adverse health effects during the use of these pesticides as no exposure assessments have been carried out within this project.

5.3 Limitation of the project

The limited number of coformulants evaluated (18 substances) in this project as well as the criteria for selection of the substances to be evaluated in the project (section 2.1) may give rise to some bias regarding the results obtained in the project. The predominant concern is that the 18 selected substances are not representative for the very high number of different coformulants used in Denmark.

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