4.23 Tolylfluanid (162)(R)

R-residue and analytical aspects

RESIDUE AND ANALYTICAL ASPECTS

Tolylfluanid, a fungicide closely related to dichlofluanid, was first evaluated for toxicology and residues by the Meeting in 1988, with a subsequent residue evaluation in 1990. It was evaluated again in 2002 under the Periodic Review Programme where the Meeting recommended a number of MRLs and the definition of the residue as follows:

For compliance with MRLs:

tolylfluanid

For the estimation of dietary intake:

sum of tolylfluanid and N,N-dimethyl-N'-(4-methylphenyl)sulfamide expressed as tolylfluanid.

Among trials data reported to the 2002 JMPR, the results of supervised trials on lettuce conducted in southern France, Italy, Portugal and Spain could not be evaluated as the closest GAP, Slovenian GAP, requires a PHI of 21 days while the maximum sampling interval in these trials was 10 days. A new registered use on lettuce was approved in Spain which requires a PHI of 7 days. The present Meeting reviewed the results of trials conducted in southern France, Italy, Portugal and Spain taking into consideration the new registered use in Spain.

Results of supervised trials

The results of supervised trials on lettuce reported to the 2002 JMPR were evaluated in the light of the new GAP in Spain.

The sum of tolylfluanid and N,N-dimethyl-N'-(4-methylphenyl)sulfamide (DMST) was calculated and expressed as tolylfluanid on the basis of the molecular weight of tolylfluanid (347.3 g/mol) and DMST (214.3 g/mol). When tolylfluanid and/or DMST was found to be below the limit of quantification, the sum of tolylfluanid and DMST was calculated as follows and expressed as tolylfluanid:

Head lettuce. Trials were conducted in Belgium, France, Germany, Greece, Italy, Portugal, Spain and the UK.

The results of trials in Germany in 1987 and 1988 at a rate of 0.1 kg ai/hl (0.6 kg ai/ha, 6 applications) were evaluated against the GAP of Germany (0.1 kg ai/hl, 0.6 kg ai/ha, 6 applications, PHI 21 days). The concentrations of tolylfluanid in 8 trials that matched GAP were <0.05 (7) and 0.17 mg/kg and those of the sum of tolylfluanid and DMST expressed as tolylfluanid were <0.07 (7) and 0.17 mg/kg.

The trials carried out in Belgium, northern France, Germany and the UK in 1997 and 1998 at a rate of 0.19 kg ai/hl were not in compliance with any GAP.

The results of trials carried out in southern France, Italy, Portugal and Spain at a rate of 0.08 or 0.1 kg ai/hl were evaluated against GAP in Spain (0.06-0.1 kg ai/hl, PHI 7 days). The concentrations of tolylfluanid in 15 trials that matched GAP and one trial in Spain with a PHI of 6 days were in ranked order 0.11, 0.26, 0.98, 1.3, 1.9, 2.1, 2.3, 2.4, 2.9, 3.1, 3.2, 3.8, 4.6, 6.0, 8.5 and 9.7 mg/kg and those of the sum of tolylfluanid and DMST expressed as tolylfluanid were 0.21, 0.42, 1.2, 1.5, 2.7, 2.9, 3.5, 3.6, 3.9, 4.3, 4.4, 4.5, 5.3, 7.1, 10 and 12 mg/kg.

The trials following German GAP showed significantly lower residues than those according to Spanish GAP. The Meeting decided to base maximum residue level on the results of trials matching Spanish GAP. The Meeting estimated a maximum residue level of 15 mg/kg to replace the recommendation by the 2007 Meeting for an MRL of 0.2 mg/kg. It also estimated an STMR of 3.75 mg/kg and an HR of 12 mg/kg.

DIETARY RISK ASSESSMENT

Long-term intake

The International Estimated Dietary Intakes (IEDIs) were calculated for the five GEMS/Food regional diets using STMRs for 12 commodities and STMR-Ps, for dried grapes, tomato juice and tomato paste estimated by the 2002 and the current Meetings (Annex 3). The ADI of 0-0.08 mg/kg bw was established by the 2002 Meeting. The calculated IEDIs were 0-4% of the maximum ADI. The Meeting concluded that the intake of residues of tolylfluanid and DMST resulting from the uses considered by the 2002 and the current JMPR was unlikely to present a public health concern.

Short-term intake

The International Estimated Short-Term Intakes (IESTI) for tolylfluanid and DMST were calculated for lettuce. An acute reference dose of 0.5 mg/kg bw was established by the 2002 JMPR. The IESTI for children was 40% of the acute reference dose and that for general population was 20% (Annex 4). The Meeting concluded that the short-term intake of residues of tolylfluanid and DMST from uses on lettuce was unlikely to present a public health concern.