1. 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

2. Risk Assessment: Di-n-butyl Phthalates (DBP) in Food
By: Lani Gabriel
And
Chantel Yanagawa

3. 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

4. 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

5. Products Containing DBP
Lotions & Suntan Lotions
increases absorption
Although DBPs are found in toys and food….
Nail polish
prevents chipping

6. Products Containing DBP (cont.)
Food Storage Containers
increases flexibility
Adhesives
increases its ability to adhere

7. Products Containing DBP (cont.)
School Supplies
increases flexibility in erasers
CHANTEL
Prescription Drugs
Used for compounding
Controls release

8. 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

9. 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.

10. 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

11. 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?

12. 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

13. 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

14. 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

15. V. Salazar et al. (cont.) Males Females
Pubertal Parameters were Studied in Pups
Males
Females
Anogenital Separation
Vaginal Opening

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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)

28. 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

29. 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

30. 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

31. Recommendations (cont.)
With additional studies the possibility of new regulations can be put into place
CHANTEL

32. Please visit Toxipedia for our list of references
Image provided by Steve Gilbert