Maternal 1200 NOAEL 2400: body weight gain Rats, SD, 25–28/group 0.25, 1, 5 % Field et al. 1993 (200, 840, 3570) Diet, GD 6–15 Developmental 3570 NOAEL Maternal 840 NOAEL 3570: food consumption and body weight gain; relative liver weight Rats, SD, 5/group 500 Liu et al. 2005 Gavage, GD 12–19 Developmental 500 NOAEL Rats, SD, 2–3/group 500 Clewell et al. 2010 GD 12–19 Developmental 500 Postnatal developmental toxicity studies Rats, SD, 5/group 750 Gray et al. 2000 Gavage, GD 14–PND 3 Developmental 750 NOAEL Fertility-related 750 NOAEL Maternal 750 NOAEL = decreased; = increased; F0 = parental generation; F1= first filial/offspring generation; F2 = second filial/offspring generation; GD = gestational day; Hb = haemoglobin; HCT = haematocrit; m-f = male-female; NOAEL (shading) = no observed adverse effect level; LOAEL = low observed adverse effect level; PND = postnatal day; SD = Sprague Dawley. 6.7 Summary DMP is rapidly and almost completely absorbed following oral administration. The bioavailability via the oral route is assessed as 100 % for both adults and children. Bioavailability via dermal absorption is not likely to exceed 10 % in humans. Data on DMP absorption via the inhalation route are limited; a default bioavailability of 100 % is considered appropriate for this route. Tissue distribution of DMP is widespread including breast milk and the placenta but there is no evidence of accumulation. DMP is also rapidly metabolised and excreted, predominantly as a metabolite, monomethyl phthalate (MMP), via the urine. DMP exhibits low acute toxicity in animals and is not expected to have significant acute toxicity in humans. Also, DMP is not expected to have eye or skin irritation, or skin sensitising potential in humans. Based on the weight of evidence, the available data do not support a mutagenic, genotoxic or carcinogenic potential for DMP.
Maternal 1200 NOAEL 2400: body weight gain Rats, SD, 25–28/group Diet, GD 6–15 0.25, 1, 5 % (200, 840, 3570) Developmental 3570 NOAEL Maternal 840 NOAEL 3570: food consumption and body weight gain; relative liver weight Field et al. 1993 Rats, SD, 5/group Gavage, GD 12–19 500 Developmental 500 NOAEL Liu et al. 2005 Rats, SD, 2–3/group GD 12–19 500 Developmental 500 Clewell et al. 2010 Postnatal developmental toxicity studies Rats, SD, 5/group Gavage, GD 14–PND 3 750 Developmental 750 NOAEL Fertility-related 750 NOAEL Maternal 750 NOAEL Gray et al. 2000 = decreased; = increased; F0 = parental generation; F1= first filial/offspring generation; F2 = second filial/offspring generation; GD = gestational day; Hb = haemoglobin; HCT = haematocrit; m-f = male-female; NOAEL (shading) = no observed adverse effect level; LOAEL = low observed adverse effect level; PND = postnatal day; SD = Sprague Dawley. 6.7 Summary DMP is rapidly and almost completely absorbed following oral administration. The bioavailability via the oral route is assessed as 100 % for both adults and children. Bioavailability via dermal absorption is not likely to exceed 10 % in humans. Data on DMP absorption via the inhalation route are limited; a default bioavailability of 100 % is considered appropriate for this route. Tissue distribution of DMP is widespread including breast milk and the placenta but there is no evidence of accumulation. DMP is also rapidly metabolised and excreted, predominantly as a metabolite, monomethyl phthalate (MMP), via the urine. DMP exhibits low acute toxicity in animals and is not expected to have significant acute toxicity in humans. Also, DMP is not expected to have eye or skin irritation, or skin sensitising potential in humans. Based on the weight of evidence, the available data do not support a mutagenic, genotoxic or carcinogenic potential for DMP.
PEC37-DMP.docx