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 GabrielAnd

Chantel Yanagawa

Physical Properties

• Soluble in:1. Ether2. Benzene3. Organic Compounds4. Water (Slightly)

• Colorless to yellow oily liquid

Di-n-butyl Phthalate (DBP)

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. Control2. DBP 0.61g/kg soy free rat chow3. DBP 2.5g/kg soy free rat chow

• Male pups were assessed for weight loss:– Total Body Weight– Thymus– Testis

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.)

V. Salazar et al. (cont.)• Pubertal Parameters were Studied in Pups

Males Females

Anogenital Separation Vaginal Opening

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.

R. Kavlock et al.• Reproductive toxicity was assessed in:

Males:1. Control2. DBP 52 mg/kg/day3. DBP 256 mg/kg/day4. DBP 509 mg/kg/day Females:1. Control2. DBP 80 mg/kg/day3. DBP 385 mg/kg/day4. DBP 794 mg/kg/day

R. Kavlock et al.

DBP Reproductive Toxicity in Rats

Male Dose (mg/kg/day)

Female Dose (mg/kg/day) Effects

0 0 N/A

52 80 ↓ Live pups/litter

256 385 ↓ Live pups/litter↓ pup weight

209 794

↓ Live pups/litter↓ pup weight↑ Liver and Kidney to body weight ratio↓ pup weight from females in crossover

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 Comments

Human Variability 10 Age difference? Diet? Ethnicity? Geographic location?

Interspecies Extrapolation 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

Dose ResponseLOAEL• 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 1Greatest 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 >1,000 ,000lbs/year

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 Prohibited (concentrations >0.1%):1. diethylhexyl phthalate (DEHP)2. dibutyl phthalate (DBP)3. butylbenzyl phthalate (BBP)

» Temporarily Prohibited (concentrations 0.1%): 1. di-isononyl phthalate (DINP)2. di-isodecyl phthalate (DIDP)3. di-n-octyl phthalate (DnOP)

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)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:– 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

Recommendations (cont.)

• With additional studies the possibility of new regulations can be put into place

References

Please visit Toxipedia for our list of references

http://www.toxipedia.org/display/toxipedia/ENV+H+472-572+A+-+Environmental+Risk

Image provided by Steve Gilbert

http://www.greencape.org/endocrine.html