Diisobutyl Phthalate (DIBP) Final

Project ID

2320

Category

IRIS

Added on

March 10, 2014, 11:43 a.m.

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Abstract  Occupational safety and health hazards associated with phthalates are reviewed. The physical characteristics of dimethyl-p-phthalate (120616), diethyl-p-phthalate (52686) (DEP), dibutyl-phthalate (84742), diisobutyl-phthalate (84695), and diethylhexyl-phthalate (117817) are presented. Production and uses of these compounds are described. Their main use is in the plastics industry which consumes about 87 percent for producing soft polyvinyl-chloride. The kinetics of phthalate metabolism by various routes of administration are described. It is noted that metabolism and toxicity are apparently linked, in that phthalates with a short alcohol chain, which are split particularly fast to monoesters, have a higher toxicity, generally provoked by monoesters in animal experiments. It is noted that the acute toxicity of these phthalates is generally slight and subchronic and chronic feeding experiments have shown relatively low toxicity in rats, mice, and dogs. Animal studies of di-2-ethylhexylphthalate (117817) (DOP) are cited which show only slight absorption through intact skin. Inhalation experiments produced no fatalities in air saturated with DOP for 2 hours, but it is reported that when exposure time was extended, all rats died within the next 2 hours. Embryotoxicity and teratogenicity are reported for DOP and DEP. Ames testing and the dominant lethal mouse test suggest weak mutagenic activity of DOP and dimethoxyethyl-phthalate. A new feeding experiment is cited in which F344-rats and B63F1-mice fed 3,000 and 6,000 parts per million DOP for 103 weeks showed an increase of hepatocellular carcinomas. Occupational exposure studies show no health disorders or chromosome aberrations in workers exposed up to 35 years. The possibility of phthalate uptake from plastics in medical equipment is also discussed. The author concludes that further research is required on possible workplace health hazards and possible ecological risks caused by concentrations of phthalates in the biosphere.

Technical Report

Abstract  Summary of how the substance meets the CMR (Cat 1 or 2), PBT or vPvB criteria, or is considered to be a substance of an equivalent level of concern: Pursuant to Annex V of Commission Regulation (EC) No 790/20091 diisobutyl phthalate (DIBP) will as of 1 December 2010 be listed in Table 3.2 (the list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Annex VI, part 3, of Regulation (EC) No 1272/20082 as toxic to reproduction category 2; R61 (May cause harm to the unborn child). Therefore, this classification of the substance in Commission Regulation (EC) No 790/2009 shows that the substance meets the criteria for classification as toxic to reproduction in accordance with Article 57 (c) of REACH.

Technical Report

Abstract  The Consumer Product Safety Improvement Act of 2008 (CPSIA) directed the U.S. Consumer Product Safety Commission (CPSC) to convene a Chronic Hazard Advisory Panel (CHAP) “to study the effects of all phthalates and phthalate alternatives as used in children’s toys and child care articles.” Specifically, Section 108(b)(2) of the CPSIA requires the CHAP to: “complete an examination of the full range of phthalates that are used in products for children and shall— (i) examine all of the potential health effects (including endocrine disrupting effects) of the full range of phthalates; (ii) consider the potential health effects of each of these phthalates both in isolation and in combination with other phthalates; (iii) examine the likely levels of children’s, pregnant women’s, and others’ exposure to phthalates, based on a reasonable estimation of normal and foreseeable use and abuse of such products; (iv) consider the cumulative effect of total exposure to phthalates, both from children’s products and from other sources, such as personal care products; (v) review all relevant data, including the most recent, best-available, peerreviewed, scientific studies of these phthalates and phthalate alternatives that employ objective data collection practices or employ other objective methods; (vi) consider the health effects of phthalates not only from ingestion but also as a result of dermal, hand-to-mouth, or other exposure; (vii) consider the level at which there is a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals and their offspring, considering the best available science, and using sufficient safety factors to account for uncertainties regarding exposure and susceptibility of children, pregnant women, and other potentially susceptible individuals; and (viii) consider possible similar health effects of phthalate alternatives used in children’s toys and child care articles. In addition, the CHAP will recommend to the Commission whether any “phthalates (or combinations of phthalates)” other than those permanently banned, including the phthalates covered by the interim ban, or phthalate alternatives should be prohibited.* Based on the CHAP’s recommendations, the Commission must determine whether to continue the interim prohibition of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DNOP) “in order to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety.”

Journal Article

Abstract  Translation of a report finalized in German in February 1997. Topics: diisobutyl phthalate; criteria document; ecotoxicology; Germany; legislation; literature survey; toxic effects; toxicology; translation.

Technical Report

Abstract  ;Contents: General Summary; Outline of Program; Summary of Acute Toxicity Data (Screening Tests) ( Acute toxicity of di isobutyl phthalate DIBP, Late deaths, Pathology, Acute toxicity of DBP, Late deaths, Pathology); Four Months Feeding Tests of Rats Given DIBP ( Growth, Mortality, Hematology, Organ Weights, Pathology, DIBP Summary); Four Months Feeding Tests of Rats Given Dibutyl Phthalate DBP ( Growth, Mortality, Hematalogy, Organ Weights, Pathology, DEP summary); Two Months Feeding Tests of Dogs Given DIBP ( Body weight, UrineAnalyses, Hematology, Organ weights, Pathology, Summary); Two Months Feeding Tests of Dogs Given DBP ( Bodyweight, Urine Analyses, Hematalogy, Organ weights, Pathology).

Journal Article

Abstract  Phthalate esters are used in a wide variety of consumer products, and human exposure to this class of compounds is widespread. Nevertheless, studies on dietary exposure of human to phthalates are limited. In this study, to assess the daily intakes of phthalate esters and the possible adverse health impacts, different food samples were collected from three areas of Cambodia, one of the poorest countries in the world. The ∑phthalate ester concentrations in Kampong Cham, Kratie and Kandal provinces ranged from 0.05 to 2.34 (median 0.88) μgg(-1), 0.19-1.65 (median 0.86) μgg(-1) and 0.24-3.05 (median 0.59) μgg(-1) wet weight (ww), respectively. Di-2-Ethylhexyl phthalate (DEHP) and diisobutyl phthalate (DiBP) were the predominant compounds among all foodstuffs. The estimated daily intake (EDI) of phthalate esters for the general population in Kampong Cham, Kratie and Kandal was 34.3, 35.6 and 35.8μgkg(-1) bw d(-1), respectively. The dietary daily intake of DEHP, benzylbutyl phthalate (BBP) and di-n-butyl phthalate (DBP) in Kampong Cham, Kratie and Kandal were below the tolerable daily intakes (TDI) imposed by the European Food Safety Authority (EFSA) and reference doses (RfD) imposed by The United States Environmental Protection Agency (USEPA). Rice contributed the greatest quantity of DEHP to the daily intake in Cambodia so may deserve further exploration. To our knowledge, this is the first study to investigate the occurrence and the daily intakes of phthalate esters in Cambodia.

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