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
BUT the majority of exposure to DBP is through food
Risk Assessment:
Di-n-butyl Phthalates (DBP) in
Food
By: Lani Gabriel
And
Chantel Yanagwa
Physical Properties
Di-n-butyl Phthalate (DBP)
• Soluble in:
1. Ether
2. Benzene
3. Organic Compounds
4. Water (Slightly)
• Colorless to yellow oily liquid
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
Products Containing DBP
Lotions & Suntan Lotions
• increases absorption
Nail polish
• prevents chipping
Products Containing DBP (cont.)
Food Storage Containers
• increases flexibility
Adhesives
• increases its ability to
adhere
Products Containing DBP (cont.)
School Supplies
• increases flexibility in
erasers
Prescription Drugs
• Used for compounding
• Controls release
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
Hazard Identification
Many Studies Indicate:
• endocrine disruption
Some Studies Indicate:
• Carcinogenic
Population at Risk
Route of Exposure
• Ingestion
– Anything containing DBP that can be put into the
mouth
• Inhalation
• Dermal and Eye contact
V. Salazar et al.
• Three study groups
1. Control
2. DBP 0.61g/kg soy free rat chow
3. DBP 2.5g/kg soy free rat chow
• Male pups were assessed for weight
loss:
– Total Body Weight
– Thymus
– Testis
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
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
V. Salazar et al. (cont.)
• Pubertal Parameters were Studied in Pups
Males
Anogenital Separation
Females
Vaginal Opening
R. Kavlock et al.
• Survey conducted on general population exposure to
DBP was estimated by:
1.
2.
3.
4.
International Program on Chemical Safety (IPCS)
UK Ministry of Agriculture Fisheries and Food (MAFF)
Health Canada
US Agency and Toxic Substance and Disease
Registry (ATSDR)
• Reproductive toxicity of DBP was reported by Wine
et al.
R. Kavlock et al.
• Reproductive toxicity was assessed in:
 Males:
1.
2.
3.
4.
Control
DBP 52 mg/kg/day
DBP 256 mg/kg/day
DBP 509 mg/kg/day
 Females:
1.
2.
3.
4.
Control
DBP 80 mg/kg/day
DBP 385 mg/kg/day
DBP 794 mg/kg/day
R. Kavlock et al.
DBP Reproductive Toxicity in Rats
Male Dose
(mg/kg/day)
Female Dose
(mg/kg/day)
0
0
N/A
52
80
↓ Live pups/litter
256
385
↓ Live pups/litter
↓ pup weight
794
↓ Live pups/litter
↓ pup weight
↑ Liver and Kidney to body weight ratio
↓ pup weight from females in crossover
209
Effects
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
Uncertainty
Factors
Score
Human Variability
10
Age difference? Diet? Ethnicity?
Geographic location?
10
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
10
No studies found on children
Total
38/50
High Level of Uncertainty
Interspecies
Extrapolation
Comments
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
Dose Response
• Uncertainty Factor = 10 x 10 x 5 x 3 x 10
= 15,000
• Rfd = Wine et al. NOAEL/Uncertainty Factors
= 50/15,000
= 0.0033 mg/kg/day
• US EPA Rfd = 0.1 mg/kg/day
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
1
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
3
Community is not well informed of DBP and little
involvement
Alternatives
3
Alternatives were not considered or found during our
research, but possible alternatives maybe available
Total
11/15 Poor support for health and community
Precautionary Assessment:
EXPOSURE ISSUES
Parameter
Score
Comment
Exposure
0
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
3
DBP is present in multiple consumer products
Occupational
exposure
0
Focused on ingestion of DBP in children
Food exposure
3
Food is estimated to be the greatest source of DBP
exposure
Total
14/20 Significant level of exposure
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
>100,000 lbs/year (only found value for Europe)
Persistent
2
Protection in the environment through deep soils and
ground water
Bioaccumulate
2
May have the potential to bioaccumulate, but was
found in high concentrations in fish
Uncertainty
3
Applicability of animal studies for humans?
Synergistic effects? Long term effects?
Total
24/30 High concern and many unknowns
Current Regulations
• US Consumer Product Safety Improvement Act 2008
» Permanently Banded:
1. diethylhexyl phthalate (DEHP)
2. dibutyl phthalate (DBP)
3. butylbenzyl phthalate (BBP)
» Temporarly Banded:
1. di-isononyl phthalate (DINP)
2. di-isodecyl phthalate (DIDP)
3. di-n-octyl phthalate (DnOP)
Current Regulations (cont.)
• California bands all 6 phthalates under Assembly Bill
1108
• European Union under Directive 2005/84/EC ONLY
bands 3 phthalates:
1. diethylhexyl phthalate (DEHP)
2. dibutyl phthalate (DBP)
3. butylbenzyl phthalate (BBP)
• Canada proposes band in 2009 similar to US (NO
update since)
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
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
Recommendations (cont.)
• Additional studies on:
–
–
–
Concentrations similar to those estimated for our
population at risk
Larger sample sizes
Synergistic effects
• With additional studies the possibility of new
regulations can be put into place
References
Please visit Toxipedia for our list of references
Image provided by Steve Gilbert
http://www.toxipedia.org/display/toxipedia/ENV+H+472-572+A+-+Environmental+Risk
http://www.greencape.org/endocrine.html