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Published byChrystal Hutchinson Modified over 9 years ago
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Phthalates in Toys A number of different phthalates are used to manufacture toys and child care products Di-n-butyl phthalates makes up less than 0.01% of toys by weight CHANTEL BUT the majority of exposure to DBP is through food
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Risk Assessment: Di-n-butyl Phthalates (DBP) in Food
By: Lani Gabriel And Chantel Yanagawa
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Physical Properties Soluble in: Colorless to yellow oily liquid
Di-n-butyl Phthalate (DBP) Soluble in: 1. Ether 2. Benzene 3. Organic Compounds 4. Water (Slightly) Colorless to yellow oily liquid
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Common Uses for DBP DBP is a PLASTICIZER that is commonly used as a (n): 1. additive for adhesives 2. softener to impart flexibility to rigid plastic products 3. solvent for oil soluble dyes, insecticides, peroxides & organic compounds 4. antifoaming agent and fiber lubricant in the textile industry
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Products Containing DBP
Lotions & Suntan Lotions increases absorption Although DBPs are found in toys and food…. Nail polish prevents chipping
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Products Containing DBP (cont.)
Food Storage Containers increases flexibility Adhesives increases its ability to adhere
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Products Containing DBP (cont.)
School Supplies increases flexibility in erasers CHANTEL Prescription Drugs Used for compounding Controls release
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Environmental Persistence
Does not readily break down in water or deep within the soil Breaks down in the presence of air and sunlight Half life of 1.8 days Does not bioaccumulate in the environment, but has the potential to DBP is not permanently bound to the polymer matrix and may leach from the plastic material into the environment
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Hazard Identification
Many Studies Indicate: endocrine disruption Some Studies Indicate: Carcinogenic Multiple animals studies have shown that DBPs act as endocrine disrupters. There have been few studies done that imply that DBPs maybe carcinogenic, but more investigations are necessary to support this theory.
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Population at Risk LANI
Mainly developing children and pregnant women because of the growing fetus Adults are exposed but they are less likely to have biological effect from endocrine disruption because they are fully developed but they could be at higher risk in the future if DBP is found to be a carcinogen Our main focus will be on children between the ages of 6 months and 4 years
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Route of Exposure Ingestion Inhalation Dermal and Eye contact
Anything containing DBP that can be put into the mouth Inhalation Dermal and Eye contact ENGAGE AUDIENCE!!!!! Ask them what kind of things a child can put in their mouth that may contain DBPS?
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V. Salazar et al. Three study groups
Control DBP 0.61g/kg soy free rat chow DBP 2.5g/kg soy free rat chow Male pups were assessed for weight loss: Total Body Weight Thymus Testis CHANTEL Thymus and testis were excised at postnatal day 14
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Weight Loss Findings of Body Weight And Thymus
V. Salazar et al. (cont.) Weight Loss Findings of Body Weight And Thymus Description Control DBP 0.61 DBP 2.5 Male pups weight (g) 24.3 ± 0.5 23.2 ± 0.7 24.8 ± 0.5 Male pups thymus relative weight (mg/g) 4.09 ± 0.39 4.13 ± 0.32 3.69 ± 0.06 Measurements were taken 14 days after birth No significant differences observed in total body weight and weight of thymus
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V. Salazar et al. (cont.) Testis Relative Weight for Male Pups Notable weight loss observed in male testis for both experimental groups compared to control
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V. Salazar et al. (cont.) Males Females
Pubertal Parameters were Studied in Pups Males Females Anogenital Separation Vaginal Opening
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R. Kavlock et al. Survey conducted on general population exposure to DBP was estimated by: 1. International Program on Chemical Safety (IPCS) 2. UK Ministry of Agriculture Fisheries and Food (MAFF) 3. Health Canada 4. US Agency and Toxic Substance and Disease Registry (ATSDR) Reproductive toxicity of DBP was reported by Wine et al. LANI
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R. Kavlock et al. Reproductive toxicity was assessed in: Males:
Control DBP 52 mg/kg/day DBP 256 mg/kg/day DBP 509 mg/kg/day Females: DBP 80 mg/kg/day DBP 385 mg/kg/day DBP 794 mg/kg/day
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DBP Reproductive Toxicity in Rats Female Dose (mg/kg/day)
R. Kavlock et al. DBP Reproductive Toxicity in Rats Male Dose (mg/kg/day) Female Dose (mg/kg/day) Effects N/A 52 80 ↓ Live pups/litter 256 385 ↓ pup weight 209 794 ↑ Liver and Kidney to body weight ratio ↓ pup weight from females in crossover
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Health Canada DBP Exposure Estimates for Estimated Intake (mg/kg/day)
R. Kavlock et al. Health Canada DBP Exposure Estimates for 6 months to 4 Years of Age Medium Estimated Intake (mg/kg/day) Ambient air 4.0 x 10-7 Indoor air 9.1 x 10-4 Drinking Water 6.2 x 10-5 Food 4.1 x 10-3 Soil 5.4 x 10-6 Total Estimated Intake 5.0 x 10-3 Estimates by IPCS, Health Canada, and ATSDR indicate the largest source of DBP exposure to the general population is through FOOD
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High Level of Uncertainty
Uncertainty Factors Score Comments Human Variability 10 Age difference? Diet? Ethnicity? Geographic location? Interspecies Extrapolation Studies were conducted in rodents. Is this applicable to humans? Acute to Chronic Extrapolations 5 Studies were based on acute exposures. Chronic exposures? Database Uncertainty 3 Were there any uncertainty factors accounted for? Children No studies found on children Total 38/50 High Level of Uncertainty
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Dose Response LOAEL per Wine et al. = 250 mg/kg/day
US EPA = 600mg/kg/day NOAEL per Wine et al. = 50 mg/kg/day US EPA = 125 mg/kg/day CHANTEL
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Dose Response Uncertainty Factor = 10 x 10 x 5 x 3 x 10 = 15,000
= 15,000 Rfd = Wine et al. NOAEL/Uncertainty Factors = 50/15,000 = mg/kg/day US EPA Rfd = 0.1 mg/kg/day
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COMMUNITY / SOCIAL ISSUES
Precautionary Assessment: COMMUNITY / SOCIAL ISSUES Parameter Score Comment Goal 1 Rfd was calculated much lower than the NOAEL listed for human intake by US EPA Need Greatest exposure occurs through food with an increased exposure through other consumer products Future Generations 3 Reproductive and developmental problems have been observe in animal studies Democratic, Community Based Process Community is not well informed of DBP and little involvement Alternatives Alternatives were not considered or found during our research, but possible alternatives maybe available Total 11/15 Poor support for health and community LANI
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Precautionary Assessment:
EXPOSURE ISSUES Parameter Score Comment Exposure No control over exposure because of cultivating , processing , and packaging material Multiple exposures 3 Presence of multiple phthalates i.e. DEHP, BBP, DINP, DIDP, & DnOP Children exposed 5 Children are more vulnerable because they are still developing mentally and physically Consumer products DBP is present in multiple consumer products Occupational exposure Focused on ingestion of DBP in children Food exposure Food is estimated to be the greatest source of DBP exposure Total 14/20 Significant level of exposure
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Precautionary Assessment:
HAZARD / TOXICITY Parameter Score Comment Hazard 7 Reproductive toxicity was observed in animal studies Individual Sensitivity 2 Infants are more susceptible than 4 year olds Ecological hazard 3 Found in the environment Volume 5 >1,000 ,000lbs/year Persistent Protection in the environment through deep soils and ground water Bioaccumulate May have the potential to bioaccumulate, but was found in high concentrations in fish Uncertainty Applicability of animal studies for humans? Synergistic effects? Long term effects? Total 24/30 High concern and many unknowns
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Current Regulations US Consumer Product Safety Improvement Act 2008
Permanently Prohibited (concentrations >0.1%): 1. diethylhexyl phthalate (DEHP) dibutyl phthalate (DBP) butylbenzyl phthalate (BBP) Temporarily Prohibited (concentrations 0.1%): di-isononyl phthalate (DINP) di-isodecyl phthalate (DIDP) di-n-octyl phthalate (DnOP) CHANTEL
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Current Regulations (cont.)
California has prohibited all 6 phthalates under Assembly Bill 1108 European Union under Directive 2005/84/EC ONLY bands 3 phthalates: 1. diethylhexyl phthalate (DEHP) dibutyl phthalate (DBP) butylbenzyl phthalate (BBP) Canada proposes band in 2009 similar to US (NO update since)
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Current Regulations (cont.)
All regulations previously discussed ONLY address consumer products in which children are exposed to In the US there is currently NO regulations in place for food and cosmetic products
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Recommendations Provide education to community on:
Presence of DBP and other phthalates How food is cultivated and packaged How to shop for DBP free alternative products Added pressures on manufacturing industries and farming community Encourage decrease of DBP use Encourage using DBP free alternatives Provide educational background on environmental & community effects CHANTEL
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Recommendations (cont.)
Additional studies on: Human exposures Investigation of diet concentrations: For specific age groups For different ethnicities Different foods (i.e. bananas, beef, carrots, etc.) Larger sample sizes Long term exposure (i.e. Chronic effects) Synergistic effects LANI
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Recommendations (cont.)
With additional studies the possibility of new regulations can be put into place CHANTEL
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Please visit Toxipedia for our list of references
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