|Evaluation year: ||2006|
|Comments: ||The Committee concluded that the critical effect of 1,3-dichloro-2-propanol is carcinogenicity. The substance yielded negative results in two new studies on genotoxicity in vivo, but limitations in these studies and positive findings in tests for genotoxicity in vitro as well as lack of knowledge on the modes of action operative at the various tumour locations led the Committee to the conclusion that a genotoxic mode of action could not be excluded. Accordingly, the cancer dose-response data were analysed by benchmark dose modelling to calculate BMD10 and BMDL10 values. The Committee concluded that a representative mean intake for the general population of 1,3-dichloro-2-propanol of 0.051 µg/kg bw per day and an estimated high-level intake (young children included) of 0.136 µg/kg bw per day could be used in the evaluation. Comparison of these mean and high-levels intakes with the lowest BMDL10 of 3.3 mg/kg bw per day, which was the BMDL10 for incidence data on tumour-bearing male rats for all treatment-affected locations, indicates margins of exposure of approximately 65 000 and 24 000, respectively.
Based on these margins of exposure, the Committee concluded that the estimated intakes of 1,3-dichloro-2-propanol were of low concern for human health. The available evidence suggests that 1,3-dichloro-2-propanol occurs at lower concentrations than 3-chloro-1,2-propanediol in soy sauce and related products, and also in acid-HVP food ingredients. However, in meat products the concentrations of 1,3-dichloro-2-propanol are generally higher than the concentrations of 3-chloro-1,2-propanediol.|
|Intake: ||Mean: 0.051 µg/kg bw per day; 95th-percentile (young children included): 0.136 µg/kg bw per day|
|Tolerable Intake: ||NONE ESTABLISHED; genotoxic carcinogen|
|Report: ||TRS 940-JECFA 67/53|
|Tox Monograph: ||67th_2007_1 3 dichloro 2 propanol.pdf|
|Previous Years: ||2001, TRS 909-JECFA 57/118, FAS 48-JECFA 57/433. Establishment of a tolerable intake was considered to be inappropriate because of the nature of toxicity (tumorogenic in various organs in rats and the contaminant can interact with chromosomes and/or DNA). The Committee noted that the dose that caused tumours in rats (19 mg/kg bw per day) was about 20000 times the highest estimated intake of 1,3-dichloro-2-propanol by consumers of soya sauce (1 µg/kg bw per day).
1993, TRS 837-JECFA 41/30,32, FAS 32-JECFA 41/267. LEVELS IN HYDROLYSED VEGETABLE PROTEINS SHOULD BE REDUCED AS FAR AS TECHNICALLY POSSIBLE
Best estimate: 0.051-0.136 µg/kg bw/day
|Pivotal Study: ||Two year oral exposure study in rats (Research & Consulting Co. AG, 1986)|
|Animal specie: ||Wistar KFM/Han rats|
|Effect: ||Carcinogenicity (adenomas and carcinomas, multiple sites)|
|Point of departure: ||BMDL10: 3.3-7.7 mg/kg bw/day for tumors at all sites in males|