Environmental Project, 943 – Evaluation of health hazards by exposure to BAM (2,6-Dichlorobenzamide) and risk characterisation of drinking water exposure

Evaluation of health hazards by exposure to BAM (2,6-Dichlorobenzamide) and risk characterisation of drinking water exposure

5 Regulations, limit values

The threshold limit in drinking water of each individual pesticide or their relevant metabolites, degradation and reaction products is 0.1 µg/l (Council of the European Union, 1998). The sum of all individual pesticides detected and quantified in the monitoring procedure should not exceed 0.5 µg/l.

BAM is listed on the following international/national lists (CHEMLIST, 2003):

EINECS (EINECS No.: 217-918-4) - Annex to Official Journal of the European Communities, 15 June 1990
SWISS (SWISS No.: G-4611) - Giftliste 1 (List of Toxic Substances 1, as amended in 2003). Toxic Category 4 (“acute oral lethal dose of 500 - 2000 mg/kg”).
AICS - Australian Inventory of Chemical Substances, June 1996 Ed.

BAM is listed on the Danish Advisory List for Self-Classification of Substances with the advisory classification: Xn;R22 (“Harmful if swallowed”) (Danish Environmental Protection Agency, 2001).

BAM is not on the list of dangerous substances (Annex I of Directive 67/548/EEC). This is the case for dichlobenil (Index No. 608-015-00-X), which is classified as:

Xn; R21(”Harmful in contact with skin”)
N; R51/53 (”Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment”)

No TDI (“tolerable daily intake”), ADI (“accepted daily intake”), MRL (“maximum residue limit”) values have been proposed by the European Commission, the Joint Expert Committee on Food Additives (JECFA), Codex or WHO for BAM or dichlobenil.

The US EPA has established tolerances for the combined residues of the herbicide dichlobenil and its metabolite BAM in or on (U.S.Environmental Protection Agency, 2001):

Apples and pears: 0.5 ppm

Blueberries, grapes, and stone fruits: 0.15 ppm

Blackberries, cranberries, and raspberries: 0.10 ppm

The Agency has evaluated the chronic dietary risk associated with the consumption of the dichlobenil metabolite BAM based on tolerance level residues, 100 % crop treated data and estimated BAM residue values for meat and milk (U.S.Environmental Protection Agency, 1998).

The RfD (“reference dose”) for BAM was determined to be 0.015 mg/kg/day based upon the NOAEL from a chronic toxicity study in dogs and an uncertainty factor of 300 (100 x 3). The uncertainty factor of 100 accounts for the inter-species extrapolation and intra-species variability. The uncertainty factor of 3 is to compensate for the lack of an acceptable BAM reproduction study. A chronic drinking water risk was assessed for dichlobenil.

The RfD for dichlobenil was determined to be 0.013 mg/kg/day based upon a NOAEL of 1.25 mg/kg/day from a two-year dog feeding study and an uncertainty factor of 100.