CPSC Hotline: 1

- 800

- 638

- CPSC (2772) CPSC's Web Site: http://www.cpsc.gov 

# Staff Report

Cadmium in Children’s Metal Jewelry

October 2010

### ii 

## Table of Contents

Staff Report

................................ ................................ ................................ ................................ .... iii

TAB A: Staff Respon ses to Peer Review Comments

................................ ................................ ... 14

TAB B: Toxicity Review of Cadmium

................................ ................................ ......................... 19

### iii 

# Staff Report

## U NITED 

## S TATES



## C ONSUMER 

## P RODUCT 

## S AFETY 

## C OMMISSION



## 4330 E AST 

## W EST 

## H IGHWAY



## B ETHESDA 

## , M ARYLAND 

## 20814

Memora ndum

CPSC Hotline: 1

- 800

- 638

- CPSC (2772) CPSC's Web Site: http://www.cpsc.gov 

## Date: October 14, 2010

TO : Mary Ann Danello, Ph.D., Associate Exe cutive Director, Directorate for Health

Sciences

THROUGH : Lori E. Saltzman, M.S., Director, Division of Health Sciences

FROM : Kristina M. Hatlelid, Ph.D., M.P.H., Toxicologist, Directorate for Health

Sciences

SUBJECT : Children’s Cadmium

- Containing Metal Jewelry 1

, 2



## Introduction

The U.S. Consumer Product Safety Commission (CPSC) administers federal laws concerning
children’s products and other consumer products. Federal laws and CPSC regulations apply
nationwide to the consumer products in interst ate commerce that are within its jurisdiction.
Since its inception, the CPSC has played a prominent role in protecting the public, especially
children, from the hazards of exposure to toxic chemicals. While the CPSC and other federal
agencies, as well as local, state, and other organizations

, have paid close attention to the potential
for exposure to lead, many other chemicals may be found in products that, if exposure occurs,

could result in adverse health effects in the users of those products.

Young ch ildren may be exposed to chemicals in consumer products from the direct mouthing of
objects, from handling such objects and subsequent hand

- to

- mouth activity, or from swallowing
a small object or a small part of a product. The specific types and frequency of behavior that a
child will engage in depends on the age of the child and the characteristics and pattern of use of
the product.

Recently, CPSC staff identified a number of products, particularly jewelry intended for use by

children that presented a ri sk of adverse health effects from exposure to cadmium.

Regulatory framework

The CPSC protects children, and consumers in general, from hazardous exposure to substances

, such as cadmium in consumer products

, under the Federal Hazardous Substances Act (FHSA)

(15 U.S.C. § § 1261

– 1278). The Federal Hazardous Substances Act requires that certain
hazardous household products ( “ hazardous substances ” ) bear cautionary labeling to alert

1 These comments are those of the CPSC staff and have not been re viewed or approved by, and may not necessarily reflect the

views of, the Commission.

2 A draft of this document was disseminated for external peer review. A summary of the peer review comments and the staff
responses to the comments may be found in Tab A.

### 2 

## consumers to the potential hazards that those products present and to inform them of the
measures they need to take to protect themselves from those hazards. Any product that is toxic,
corrosive, flammable or combustible, an irritant, a strong sensitizer, or that generates pressure
through decomposition, heat, or other means requires l abeling, if the product may cause
substantial personal injury or substantial illness during or as a proximate result of any customary

or reasonabl y foreseeable handling or use, including reasonabl y foreseeable ingestion by

children.

The FHSA gives the Comm ission authority to ban by regulation a hazardous substance if it
determines that the product is so hazardous that the cautionary labeling required by the act is
inadequate to protect the public. Any toy or other article that is intended for use by childre n and
that contains a hazardous substance is also banned under the FHSA if a child can gain access to

the substance.

Regulating products under the FHSA generally requires assessment of exposure and risk.
Assessments are generally conducted on a case

- by

- ca se basis, considering the specific
characteristics of the product, the intended consumers of the product, and the interaction between
the consumer and the product.

This document provides the staff’s approach to assessing products under the FHSA, summarizes
the relevant toxicology of cadmium, derives limits for exposure that

, if exceeded

, could result in
adverse health effects, and discusses the results from analytical tests that could result in further
scrutiny of products that may cause excessive exposure to cadmium in children who use the
products.

Cadmium Toxicology

This section includes a brief overview of cadmium toxicology. The staff prepared a separate
toxicity review that includes a broader discussion of the available data

, 3



## The adverse health effects of cadmium exposure in humans have been documented largely in
occupational settings, and mostly through inhalation, although nonworker populations have been
studied as well. The princip a l effects of long

- term exposure s are chronic obstructive pulmonary
disease and emphysema from inhalation of cadmium and cadmium compounds , and chronic

renal tubular disease from inhalation and oral exposures

. Depending on the dose and duration of
exposure, effects have been observed in multi ple organ systems and tissues, including kidney,

liver, and bone. Although cadmium exposure in workers through inhalation is associated with
lung cancer, there is insufficient evidence in humans or experimental animals to determine

whether cadmium is carc inogenic from oral exposure. which may be found in

Ta b B.

Cadmium and cadmium compounds are poorly absorbed following ingestion, unless the levels
are high enough to cause damage to the gastrointestinal tract. Absorbed cadmium accumulates
largely in the kidney and liver, with a very long half

- life, which is measured in decades. Only a
small portion of the absorbed cadmium is excreted in the urine or in feces. Consequently,
cadmium exposures are cumulative.

3 “ Toxicity Review of Cadmium.” CPSC Memorandum from Dominique J. Williams and Krist ina M. Hatlelid, Ph.D., M.P.H. to
Mary Ann Danello, Ph.D. August 2010.

### 3 

## The forms of cadmium in consumer products vary from cadmium metal in certain metal alloys,
including materials used in soldering and electroplating, to cadmium salts and other compounds
used in materials such as paints and plastics. Cadmium is found widely in the environment, in
foods, and in tobacco. Diet is the major source of cad mium exposure for most people.

Exposure to cadmium also may occur through contact with some consumer products. Exposures
from products, especially in children, are most likely from handling objects and then transferring

material from the hands to the m outh, through direct mouthing of objects, and from swallowing
small objects or parts of products. Staff identified information relating to ingestion of cadmium
and cadmium compounds as most relevant to the assessment of cadmium exposures from

consumer pro ducts.

Existing Exposure Limits

Several limits for exposure to cadmium have been established for regulatory or other purposes.
For example, the World Health Organization (WHO) has developed a Provisional Tolerable
Monthly Intake level (PT M I) of 25 microgr ams per kilogram body weight per month 4 

## ( 25
μg/kg/ month ) (or 0.8 μg/kg/day) (JECFA

, 20 1 0). The U.S. Environmental Protection Agency

(EPA) developed an oral reference dose (RfD 5 

## ) of 1 μg/kg/day for food intake and 0.5 μg/kg/day

for cadmium in drinking wate r (different levels of absorption of cadmium from food or from
water account for the different RfD values) (EPA

, 1994). The Agency for Toxic Substances and
Disease Registry (ATSDR) developed a minimal risk level (MRL 6 

## ) for chronic 7



## The ATSDR’s 2008 draft toxicological profile also includes an MRL for intermediate length
exposure of 0.5 μg/kg/day based on effects on bone in experimental animals. D ue to inadequacies in the acute oral exposure database, the ATSDR has not derived an acute duration

MRL. oral exposure of

0. 1 μ g /kg/day (AT SDR

, 2008). T hese limits were based on studies of kidney effects in humans.

The preceding exposure limits are for general use ( e.g. , PT M I, MRL) or apply to specific
exposure media ( e.g. , RfD for food or water). A child

- specifi c standard for cadmium exposure
exists in the form of the European toy safety standard EN 71

- 3 (European Standard EN 71

- 3,
1994). Under this standard, the limit for exposure to cadmium from toys for young children is
0.6 μg per day, based on information c oncerning normal background cadmium intake levels and
a policy decision to limit cadmium exposure from toys to 5 percent of the assumed background

exposure. Recently, the EC toy safety directive (Council Directive

, 2009) established new

health

- based expos ure limits for toys , using recent data on kidney effects in humans, including
studies considered by the ATSDR (2008) and CPSC staff in the current evaluation . Effective
July 20, 2013, the European toy safety standard for cadmium exposure from toys is base d on an
exposure limit of about 0.2 μg per day. Note that these toy safety standard daily limits are not

4 Exposure limits are generally expressed in terms of milligrams of exposure per kilogram body weig ht. Since 1 mg = 1,000 μg,

1 μg/kg/day is equivalent to 0.001 mg/kg/day.

5 The EPA’s RfD is defined as an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the
human population (including sensitive subgroups) that is likely to be without an appr eciable risk of deleterious effects during a

lifetime.

6 The ATSDR’s MRL is an estimate of the daily human exposure to a hazardous substance that is likely to be without appreciable
risk of adverse noncancer health effects over a specified duration of expo sure

.

7 As defined in the ATSDR toxicological profiles, chronic exposure is exposure to a chemical for 365 days or more; intermediate
exposure is 15 through 364 days; acute exposure is 1 through 14 days.

### 4 

## expressed in terms of body weight, but are daily limits for cadmium exposure that have been
adjusted to account for the weight of a young child (7.5 k ilograms for the revised standard

— about 16.5 pounds).

Long

- Term Exposure

A number of additional chronic exposure studies are now available that allow for dose

- response analysis

, and can be used to estimate an acceptable daily intake level (ADI). The staff ’s
calculations generally are based on the study reporting the lowest exposure levels associated with
adverse effects (lowest observed adverse effect level or LOAEL) or a dose that was not
associated with an adverse effect ( no observed adverse effect level or NOAEL ). A number of
high quality studies have considered cadmium

- related adverse effects in the kidney and bone,
reporting quantitative estimates for the level of cadmium intake that is associated with adverse

effects ranging across about one order of magnitude (i.e., the high end of the range is about 10
times the low end of the range).

Staff chose the analysis of an epidemiological study by Suwazono et al. (2006) as the key study
for a number of reasons, including that the study was based on a larg e, well

- characterized
population without any identified source of environmental or occupation al exposure ; the
modeling included multiple covariates to account for potential confounders ; and the estimated
cadmium exposures associated with adverse health eff ects were among the lowest of several

studies. Suwazono et al. (2006) used a benchmark dose 8 

## approach to analyze the data from a
study of 820 Swedish women. The analysis estimated the concentration of cadmium in urine
associated with urinary protein mark ers for adverse effects in the kidney. These researchers
reported 0.5 micrograms cadmium per gram creatinine 9



## Because the BMDL is a measure of cadmium excreted in urine, additional analysis is required to
estimate the corresponding level of cadm ium intake into the body . This can be done using
modeling techniques. The derivation of the MRL presented in the draft ATSDR Toxicological
Profile for Cadmium (ATSDR

, 2008) has applied such an analysis using the results of several
studies of European pop ulations, including Suwazono et al. (2006). For a 0.5 μg/g creat. urinary

concentration, the analysis published by the ATSDR (2008) estimated a level of cadmium intake

of 0.33 μg/kg/day . This is the intake level chosen by CPSC staff as the critical expos ure level. in the urine (0.5 μg/g creat.) as the lower
confidence limit of the cadmium concentration benchmark dose level ( i.e. , BMDL associated
with a 5 pe rcent excess risk of protein in the urine). Similar results were reported by Uno et al

. (2005) and Järup et al . (2000).

The scientific community generally addresses uncertainty in the comprehension of toxicology

and dose

- response through the use of uncertainty factors. CPSC staff also uses an uncertainty
factor approach in evaluating exposure levels to account f or a lack of robust data from animal
studies or a lack of information from human exposures (CPSC

, 1992). CPSC staff may apply up
to three uncertainty factors, depending on the completeness and relevance of the available data.
An uncertainty factor may be used if data are available only in studies of animals and not in
humans. An uncertainty factor is applied if the available studies do not identify a dose or

8 A benchmark dose approach uses mathematical modeli ng to characterize exposure

- response relationships.

9 Urinary cadmium concentrations were normalized to the amount of creatinine also present in the urine, a common method that
accounts for the variations in excretion of urine and that allows comparison of urinary measurements over time, between subjects,

or from different studies.

### 5 

## exposure level that is not associated with an adverse effect ( NOAEL)

. When a benchmark dose

appr oach is used, the BMDL is treated as a NOAEL. The third type of uncertainty factor is
applied to account for sensitive populations if the available studies do not adequately address

such concerns.

In this case, only one uncertainty factor is needed, which is intended to account for the
possibility of sensitive members of the population. The staff has chosen to apply a reduced
uncertainty factor of 3, rather than the factor of 10 that is more typically used because of lack of
knowledge of effects throughou t a population. The reduced uncertainty factor is appropriate in

this case because of the strength of the data that supports the identified critical exposure level,

which is based on multiple studies of large numbers of people in different parts of the wo rld.
Therefore, an uncertainly factor of 3 applied to the intake level of 0.33 μg/kg/day results in an
acceptable daily intake (ADI) of 0.1 μg/kg/day. This is the level of chronic exposure that should

not be exceeded to avoid adverse health effects.

The key study used to estimate the ADI (Suwazono et al.

, 2006) was based on data from adult
women in a population that had no particular source of exposure to cadmium. Because the study
participants likely experienced exposures to cadmium throughout their liv es, such as through
normal dietary sources, staff believes that the ADI may be applied to various scenarios involving
exposures from consumer products during childhood and later in life.

Another issue to consider is the use of toxicokinetic modeling to rel ate intake of cadmium to
absorption into the body, distribution within the tissues and organs of the body, and elimination

from the body. Recent data indicate that children age s 6 through 11 years and females show
increased urinary excretion of cadmium (R uiz et al

. 2010 ). This finding could indicate important
differences in exposure and uptake of cadmium in these populations. Again, the epidemiological
study that was used to estimate the acceptable daily intake level was conducted in women who
likely exp erienced exposures to cadmium throughout their lives, including childhood. Although
uncertainty remains on the implications of possible differences among various groups, the
relatively large body of literature concerning long

- term exposure and effects of cadmium
supports the staff’s approach.

Intermediate and Acute Duration Exposure

Documented acute 10

10 Acute exposures, 14 days or less, 16 C.F.R. §1500.3(c)(2)(i). Intermediate exposure duration is not defined within CPSC
regulations, but generally means longer than acute exp osure, but less than chronic; this term is defined in the ATSDR
toxicological profiles as 15 to 364 days. 

## exposures in humans generally have involved exposure to relatively large
amounts of cadmium compounds

, resulting in severe adverse effects, including death. One
report of a nonfatal exposure in humans was published by Nordberg et al. (1973). This case
involved gastrointestinal symptoms in boys 13 through 15 years old following ingestion of a
beverage containing cadmium from a soda machine. Investigation of th is case included analysis
of a sample of water from the machine that contained 16 milligrams of cadmium per liter

(16 mg/L). It is not clear from the report when the water sample was collected or how it was
handled prior to testing for cadmium content. B ased on information collected from the boys
about five months after the incident, symptoms began within 15 minutes of consumption of the
drink, and included headache, nausea, vomiting, abdominal pain, and diarrhea. All symptoms

resolved within seven hours , and most of the boys returned to school when classes resumed after

the weekend three days later. The childre n reported consuming 0.5 to 2.5 glasses of the drink

,

### 6 

## with an average of about one glass. A lthough the volume of beverage consumed was not

repor ted , information in the publication’s discussion suggests that the investigators considered a
glass to be about 0.15 L. Using this estimate for the average intake, the toxic dose of cadmium
was about 2.4 mg. Because of the high level of uncertainty in th is quantitative estimate and
inadequate documentation of the case

, staff finds this study unacceptable for further quantitative
analysis or derivation of an exposure limit

. Staff has not located other studies or reports of

health effects from short

- term o ral exposure in humans at doses that are not associated with

severe adverse health effects or death. Nor has staff located any reports of persistent effects after
a brief exposure has ended, or studies that measured long

- term effects resulting from an acu te exposure to cadmium.

Several studies in animals have been conducted involving single exposures or short

- term dosing,
usually at relatively high doses. Adverse effects have been reported for multiple tissues and
organ systems, includ ing death, and effec ts in the liver, kidney, and bones. M ost of the studies

are not suitable for use in dose

- response analysis for deriving exposure limits because of the
severity of the adverse effects associated with the dose levels chosen for the studies

. Of the

studies that are appropriate for use in extrapolating to an acceptable intake level for humans, the
staff chose as the key study

, the evaluation of short

- term exposure in rats through drinking water
by Borzelleca et al. (1989).

This study involved groups of male and female rats that were exposed to cadmium chloride in
drinking water for 10 days. Cadmium exposure was calculated at 1.1, 7.8, and 11.1 mg/kg/day in
males, and 1.1, 8.1, and 13.8 mg/kg/day in females, based on the concentration of cadmium

chloride in the water and the animals’ water intake. The authors noted a dose

- dependent
decrease in body weight gain among males. The summary data also appear to show reduced
body weight in the highest dose group in males, and dose

- related reduced body weight gain i n females, but statistical analyses were not presented.

Because of the disagreeable taste of water containing cadmium chloride, reduction in body
weight or reduction in body weight gain may be due to the tendency of the animals to reduce

their water intake with a concomitant reduction in food intake. However, the same publication
(Borzelleca et al. , 1 989) included a study in which dosing through gavage ( i.e. , delivery of the
dose directly into the stomach th r ough a feeding tube) also resulted in reduced bo dy weight and
reduced body weight gain. This latter study suggests that cadmium exposure affects body weight
through means other than the effect on the taste of the drinking water, and, therefore, changes in
the body weight endpoints should be considered related to the exposure. The results of this study
are supported by findings of body weight effects in two other animal studies involving dosing
through gavage (Baranksi , 1 985; Machemer and Lorke , 1 981).

For exposures through both gavage and drinking wate r, Borzelleca et al. (1989) also noted
significant changes in certain clinical chemistry measures, suggesting systemic effects in
addition to the effects on body weight. Therefore, staff concludes that short

- term exposure to

cadmium is associated with adv erse effects in animals. The lowest dose administered in the
drinking water study (1.1 mg/kg/day) (Borzelleca et al. , 1 989) can be considered the no
observed adverse effect level (NOAEL) and is appropriate for extrapolating to an acceptable

intake level for humans.

As with the estimation of a longer term ADI, for an acute duration exposure limit, staff identifies
the LOAEL or NOAEL and applies up to three uncertainty factors to account for sensitive

### 7 

## individuals, the use of a LOAEL instead of a NOAEL if that is the case, and for the use of data
from studies in animals instead of in humans if that is also applicable. Consequently, the acute

ADI for cadmium is 11 μg/ kg/day

, based on the N OAEL of 1. 1 mg /kg/day

, and the use of an
uncertainty factor of 10 for the use of data from animals rather than humans, and another factor

of 10 to account for sensitive individuals in human populations

. No information was located for human oral exposures of intermediate length duration. However,
recent studies in young rat s demonstrate dose

- related effects on bone metabolism and bone
biomechanical properties for exposure s up to 12 months (Brzóska and Moniuszko

- Jakoniuk

2005). Based on a number of effects reported at the lowest dose tested, the LOAEL for the

intermediate du ration study is approximately 0.2 mg/kg/day. The intermediate exposure MRL of

0.5 μg/kg/day presented in the recent draft toxicological profile (ATSDR 2008) was derived
using a benchmark dose approach to analysis of this data.

In general, the animal studi es conducted in acute exposure scenarios and intermediate duration
scenarios indicate a very wide range of LOAELs and NOAELs ( i.e. , orders of magnitude
difference between lowest and highest reported values) including, in some cases, adverse effect

dose lev els that are comparable to the LOAELs and NOAELs reported in longer

- term studies
(see summary in Table 3.6, ATSDR 2008). As discussed above, ADIs, MRLs, and RfDs derived
from chronic and intermediate duration studies range across about one order of magnit ude. No

acute exposure limits have been derived previously for oral exposure to cadmium.

Because cadmium is found in the environment, in foods, and in tobacco, most people experience
some level of exposure to cadmium. Any additional exposure to cadmium f rom consumer products will add to the overall risk of adverse health effects that might be associated with other

sources of cadmium.

Evaluation

Children’s jewelry is not a distinct, easily

- defined product for a specific group of consumers.

Rather, this ca tegory of products could encompass a large variety of jewelry products suitable for
children of specific ages or for children of all ages. Because exposure to substances is the focus

of staff’s assessment, the assessment will f ocus on a group of children likely to participate in the
behaviors that could result in excess exposure to the substances

, and who are also the most
vulnerable to the effect of the possible exposures. In this case , staff has chosen to consider
young children ages 2 through 6 years o ld. Children in this age group still have significant
mouthing behaviors, and occasionally may swallow

— accidentally or intentionally

— small
objects. This age group may also be of special concern because of the potential health effects of
cadmium exposure in people at early stages of development, similar to the concern about lead
exposure in young children

. However

, data currently do not exist that clearly show adverse
health effects specifically associated with exposures in early childhood

.

Children are n ot expected to use certain pieces of jewelry, such as a charm bracelet

, throughout

their daily life

. Some jewelry, such as jewelry with seasonal themes, may be used for a few
weeks, and pieces that are especially valued by the child or by their parents

, m ay be worn only
occasionally. However , some jewelry, such as inexpensive items, may be used frequently or until the item is no longer favored by the child or is lost. For this evaluation , staff assumes that a
child will use a jewelry item frequently over weeks, months, or years.

### 8 

## Exposure to cadmium from metal jewelry items or similar objects could occur during handling or
mouthing the product

, or from swallowing a pendant, bead, or other small component part of
jewelry.

An ingested product could result in an acute or short

- term exposure, because ingested objects are
usually eliminated from the body within a few days or possibly weeks. Therefore, data on the

effects of acute or short

- term cadmium exposure would be most relevant for an assessment of

swallow ed jewelry items.

As discussed above, acute exposure in humans and experimental animals causes a number of

adverse effects. Because of the uncertainty regarding the circumstances and quantitative details
of human exposure cases, staff has chosen to eval uate short

- term exposures using the study in
experimental animals by Borzelleca et al. (1989) to derive an ADI for acute exposure of

11 μg/kg/day.

To assess children’s cadmium

- containing jewelry, staff assumes that the vulnerable group of

children is 2 to 6 years old, with an average weight of 1 8

. 2 kg ( 40 pounds) (Ogden et al. 2004)

. Given the 11 μg/kg/day acute ADI, the maximum allowable acute exposure for a young child
is about 200 μg/day

. Handling or mouthing a product could result in a longer

- term ex posure because use of the
product could occur over many weeks, months, or years. I n contrast to acute exposure, long

term exposure to cadmium has been studied extensively and is well characterized. Given data
from multiple studies, staff prefers to use s tudies in humans for characterization of human risks.
Thus, because of the strength of the evidence in studies of human populations, staff has chosen to
use epidemiological information (Suwazono et al. 2006) in the assessment of exposure to

cadmium from c hildren’s jewelry. As discussed above , staff derived an acceptable daily intake
level (ADI) for cadmium of 0.1 μg/kg/day for chronic exposure. Given the 18.2 kg body weight
for children age s 2 to 6 years, and the 0.1 μg/kg/day ADI, the maximum allowable chronic
exposure for young children is about 1.8 μg/day

. Ingestion of foreign bodies

As discussed in the staff’s briefing package on lead

- containing children’s metal jewelry, several
cases show that excessive exposure to lead resulted from children swallow ing lead

- containing
metal jewelry items (CPSC 2006a).

Further, as documented in the briefing package, jewelry items are among the most commonly
ingested items by young children (CPSC 2006b). Staff analyzed data from the National
Electronic Injury Surveill ance System (NEISS) database on emergency room

- treated injuries
associated with ingestion of consumer products by children. For 2000

– 2005, the staff estimated
302,587 emergency room

- treated injuries, nearly 80 percent of which were children under age

7 ye ars. The objects most commonly swallowed were coins ( accounting for nearly half of
ingestions ) ; jewelry; toys not elsewhere classified; and nails, screws, tacks

, or bolts.

Additional data on ingestion of objects are found in a 1998 study that evaluated 10 0 children

age s 9 months to 13 years

, who ingested various foreign bodies, including coins, ball bearings,
pins, marbles, screws, buttons, a light bulb, a novelty nail file

, and a clothespin (Macgregor and
Ferguson , 1 998). This study evaluated how long an ingested object might remain within the
gastrointestinal tract. The total transit time for passage (from ingestion to elimination through

### 9 

## the rectum) of the items ranged from 1 to 46 days. The peak time of passage was 2 days

, with a
median time of 6 day s. The authors noted that the mean transit time for an ingested object
increased with age; it was greater than 15 days for 13 year olds

, while it was typically 5 days for
4 through 10 year olds.

Thus, the available information show s that children may swal low items such as jewelry, and that
ingested items can cause excessive exposure to chemicals from the swallowed items.

Assessment

Exposure to cadmium from children’s metal jewelry could occur as children use and interact
with a product. This exposure migh t occur from activities such as mouthing a product or
handling the product with subsequent hand

- to

- mouth transfer of cadmium that might be removed
from the surface of the product. This exposure could occur over the many days or months that a

child uses a product such as metal jewelry. Exposure to cadmium also might occur if a child
swallows a small item or a part of an item. In the case of ingestion of a product, the exposure
would occur during the usually short time that the item remains in the gastroin testinal tract,
notwithstanding the possibility that an ingested object sometimes is retained in the body for

several weeks.

Staff evaluates possible exposures to cadmium or other chemicals from children’s products by
measuring leaching of the cadmium from the item using a saline solution to mimic the effects of
mouthing, and a dilute hydrochloric acid solution to simulate the gastric effects on a swallow ed

item. The staff’s standard laboratory procedure is to immerse an item in the saline solution for a

p eriod of six hours. Because of the data showing that ingested items sometimes remain in the
stomach for several days, for products such as metal jewelry, staff conducts the dilute acid
leaching test for 24 hours. Data generated by the staff indicates tha t 24 hours is generally

sufficient time to identify products that could leach large amounts of chemicals.

Mouthed object

For the case of mouthing, staff assumes that each minute of extraction in the saline solution
represents a minute of mouthing of the o bject by a child. A CPSC study of mouthing behaviors
of young children estimated an average daily mouthing time of 37 minutes for all objects
(excluding pacifiers) for children age s 24

– 36 months (CPSC 2001).

Using the saline extraction to simulate the eff ects of mouthing a jewelry item, with the
assumption that mouthing a children’s product for 37 minutes per day represents an excess
exposure, and that the ADI for chronic exposure to cadmium is 1. 8 micrograms per day for a
young child, the ADI would be exc eeded if the results of the saline extraction of the item exceeds

18 micrograms total cadmium extracted during the 6

- hour saline extraction (Eq. 1).

(1. 8 μg/day)/(37 min/day) x (6 hours x 60 min/hour) = 1 8 μg (Eq.1)

where

1.8 μg/day is the chronic acceptab le daily intake level (ADI) for children 2

– 6 year s old

, 37 min/day represents the daily mouthing time of jewelry, and
6 hours x 60 min/hour is the number of minutes each jewelry item is tested for leaching

of cadmium into the saline solution in the labor atory evaluation.

### 10 

## Therefore, a test result for saline extraction of a mouthable product that exceeds 1 8 μg indicate s that the product may meet the criteria established in the FHSA for a product to be considered a
hazardous substance.

Swallowed object

Swall owing a cadmium

- containing object is an acute exposure situation, for which the available
toxicology database is limited . However, the need to evaluate products for the potential for acute
exposure to cadmium prompted staff to cho o se data from acute studi es in experimental animals
to derive an acute exposure limit of 200 μg/day.

In contrast to repeated exposure s to small amounts of a chemical over time, ingestion of an item

results in the total exposure from the item occurring within a short time ( i.e.

, an acute exposure )

. The acute ADI would be exceeded if the result of the acid extraction of the item exceeds

200 micrograms total cadmium extracted during the 24

- hour acid extraction.

Therefore, based on the available data on acute exposures, a test re sult for acid extraction of a
swallowable product that exceeds 200 μg would indicate that the product may meet the criteria
established in the FHSA for a product to be considered a hazardous substance.

Conclusion

Given the available information on cadmium toxicity and the assumptions about children’s

interactions with cadmium

- containing products , staff has estimated limits for testing that may be
used for evaluating children’s jewelry under the FHSA. For a product that may be mouthed by a

child , staff conc ludes that a result from the 6

- hour saline extraction test that exceeds 1 8 μg would
indicate that the product may meet the criteria established in the FHSA for a product to be

considered a hazardous substance based on chronic toxicity . For a product or pa rt of a product
that may be swallowed by a child, the staff concludes that a result for the 24

- hour acid extraction
test that exceeds 200 μg would indicate that the product may be considered a hazardous

substance based on acute toxicity

.

In order for a sub stance to be considered a hazard under the FHSA, both exposure and the risk of
adverse health effects associated with handling and use of the substance must be taken into

account . Therefore, the characteristics of the product and a child’s behaviors and i nteractions
with the product must be considered along with the information on toxicity

.

Discussion

This evaluation provides an approach to assessing cadmium

- containing children’s metal jewelry
that takes into account both acute exposure ( e.g. from swallowi ng ) and longer term exposures ( e.g. from repeated mouthing behaviors over time )

. A key consideration in the toxicology of cadmium is that once absorption of cadmium occurs, it
remains in the body, particularly in the kidneys and liver, for many years. Gi ven the very long

half

- life of cadmium in the body, exposures that occur from swallowing an object or from
mouthing an object over time could have significant impacts on the overall exposure to cadmium

from all sources and contribute to the risk of adverse health effects from cadmium exposures.

The evaluation is based on a number of assumptions about children’s behaviors, product

characteristics

, and relevant testing methods, and the existing knowledge base for cadmium
toxicology. Because of the known haza rds associated with human exposure to cadmium, staff
has taken a conservative approach by using an estimated acceptable daily intake level (ADI) for

### 11 

## chronic exposure and assuming a relatively high level of mouthing activity. The acute exposure

scenario wa s evaluated using data on adverse health effects from short

- term exposure to cadmium in animals because that data is most relevant to the possible scenario in which a child

swallows a cadmium

- containing item.

The approach in this assessment to longer term exposure from mouthing items is conservative,
largely because of the assumptions about the behaviors expected in very young children. S taff
used data from an observation study for mouthing of all objects during a day, which would
overestimate exposure tha t might occur from a particular product. Furthermore, the staff’s

assessment of mouthing behaviors that occur over time is based on an acceptable daily intake
level that is not expected to cause adverse effects if the exposure occurred over many years.

Wh ile staff has taken a conservative approach

, e xposure to cadmium is associated with
significant health effects, and any exposure from consumer products, such as jewelry, is in
addition to exposures that most people experience from food, water, and other so urces.

### 12 

## References

ATSDR ( 2008 ) Toxicological Profile for Cadmium ( Draft ). Agency for Toxic Substances and
Disease Registry. U.S. Department of Health and Human Services.
http://www.atsdr.cdc.gov/toxprofiles/tp5.html

. Baranski B (1985) Effect of exposure of pregnant rats to cadmium on prenatal and postnatal
development of the young. J Hyg Epidemiol Microbiol Immunol 29:253

– 262.

Brzóska MM, Moniuszko

- Jakoniuk J (2005) Disorders in bone metabolism of female rats
chronically exposed to cadmium. Toxicol Appl Pharmacol 202(1):68

– 83.

Council Directive 2009/48/EC of 18 June 2009 on the safety of toys. Official Journal L 170,
30.6.2009, pp. 1

– 36.

CPSC ( 1992 ) Labeling requirements for art materials presenting chronic hazards; guidelines for
determining chronic to xicity of products subject to the FHSA; supplementary definition of
"toxic" under the Federal Hazardous Substances Act; final rules. 57 Fed. Reg.: 46626

– 46674 (9
October 1992).

CPSC (2001). A mouthing observation study of children under 6 years. CT Kiss.

CPSC (2006a) Memorandum from Kristina M. Hatlelid and Jacqueline Elder to the Commission,
Todd A. Stevenson, Secretary. “ Petition HP 06

- 1 Requesting Ban of Lead in Toy Jewelry ,” dated
December 4, 2006. In: Briefing Package for Petition Requesting Ban of Lead in Toy Jewelry
(Petition No. HP 06

- 1) . December 4, 2006.

CPSC (2006b) Memorandum from Craig O’Brien to Kristina M. Hatlelid. “ Analysis of Data on
Child Ingestions ,” dated November 30, 2006. In: Briefing Package for Petition Requesting Ban

of Lead in Toy Jewelry (Petition No. HP 06

- 1) . December 4, 2006.

EPA (1994) Integrated Risk Information System

, Cadmium (CASRN 7440

- 43

- 9)

. http://www.epa.gov/iris/subst/0141.htm

. European Standard EN 71

- 3 (1994) Safety of Toys

— Part 3: Migration of certain elements.

Järup L, Hellstrom L, Alfven T, Carlsson MD, Grubb A, Persson B, Pettersson C, Spang G,
Schutz A and Elinder CG (2000) Low level exposure to cadmium and early kidney damage: The
OSCAR study. Occup Environ Med 57(10):668

- 672.

JECFA (20 1 0) Summary and conclu sions of the seventy

- third meeting, Geneva, 8

– 1 7 June 20 1 0.
Geneva, World Health Organization, Joint FAO/WHO Expert Committee on Food Additives.

Macgregor D, Ferguson J (1998) Foreign body ingestion in children: an audit of transit time. J
Accid Emerg Me d 15: 371

– 373.

Machemer L and Lorke D (1981) Embryotoxic effect of cadmium on rats upon oral
administration. Toxicol Appl Pharmacol 58:438

– 443.

Nordberg G, Slorach S, Steinstrom T (1973) [Cadmium poisoning caused by a cooled

- soft

- drink

machine.] Lakarti d ningen 70: 601

– 604.

Ogden CL, Fryar CD, Carroll MD, Flegal KM (2004) Mean bodyweight, height, and body mass

index, United States 1960

– 2002. Advance data from vital and health statistics; no 347.
Hyattsville, Maryland: National Center for Health Statistics

.

### 13 

## Ruiz P, Mumtaz M, Osterloh J, Fisher J, Fowler BA ( 2010 ) Interpreting NHANES

biomonitori ng data, cadmium. Toxicol Lett 198(1):44

– 48.

Suwazono Y, Sand S, Vahter M, Filipsson AF, Skerfving S, Lidfeldt J, Akesson A (2006)

Benchmark dose for cadmium

- induced renal effects in humans. Environ Health Perspect

114:1072

– 1076.

Uno T, Kobayashi E, Suwazono Y, Okubo Y, Miura K, Sakata K, Okayama A, Ueshima H,
Nakagawa H and Nogawa K (2005). Health effects of cadmium exposure in the general
environment in Japan with sp ecial reference to the lower limit of the benchmark dose as the
threshold level of urinary cadmium. Scand J Work Environ Health 31(4): 307

– 315.

### 14 

# TAB A : Staff Responses to Peer Review Comments 

# T

A

B

A

## U NITED 

## S TATES



## C ONSUMER 

## P RODUCT 

## S AFETY 

## C OMMISSION



## 4330 E AST 

## W EST 

## H IGHWAY



## B ETHESDA 

## , M ARYLAND 

## 20814

Memora ndum

CPSC Hotline: 1

- 800

- 638

- CPSC (2772) CPSC's Web Site: http://www.cpsc.gov 

## Date: October 14, 2010

TO : Mary Ann Danello, Ph.D., Associate Executive Director, Directorate for Health

Sciences

THROUGH : Lori E. Saltzman, M.S., Director, Division of Healt h Sciences

FROM : Kristina M. Hatlelid, Ph.D., M.P.H., Toxicologist, Directorate for Health

Sciences

SUBJECT : Staff Responses to Peer Review Comments on “ Children’s Cadmium

– Containing Metal Jewelry ” 1



## In June 2010, Consumer Product Safety Commission ( CPSC ) staff sought external scientific peer

review of staff’s draft document, “Children’s Cadmium

- Containing Metal Jewelry.” Comments
from the three reviewers were received by staff in July 2010. Staff revised the draft document
based on the peer revie wers’ comments and provide s brief responses to the comments here.
Similar comments or comments pertaining to specific topics are grouped and addressed together.

Comment

There were several specific observations related to sentence structure, wording, or cl arity of the
text, and a general comment that the document should contain more background on the purpose
of the document and the regulatory approach.

Response : Staff revised the text accordingly to address both the specific and general comments

about the d ocument.

Comment

Among the three reviewers ’ comments were somewhat conflicting conclusions that the ADI
approaches and data used are appropriate, or that there are deficiencies in the approach and

discussion.

Response : The staff carefully considered each comment and revised the draft document to best
address the comments and present an appropriate evaluation of the available data and

information.

1 The responses to the peer review comments are those of the CPSC staff and have not been reviewed or approved by, and may
not necessarily reflect the views of, the Commission.

### 16 

## Comment

A comment concluded that the review is incomplete, specifying that the form of cadmium and

dose route in the toxicology studies should be included, as well as the form of cadmium expected
from exposure to children’s products. The review should include discussion of the renal cortex

concentration threshold concept and database.

Response : The staff documen t was revised to include additional material and a greater level of
detail to address the reviewers’ concerns, although this document is not intended to be a
standalone toxicity review. S taff’s toxicity review of cadmium, a document produced separately

fr om the reviewed evaluation

, also addresses some of the reviewers’ comments.

Comment

Consider the bone effects in the derivation of the ADI.

Response : While adverse effects on bone are important outcomes from exposure to cadmium,
published analys e s of epide miological data show that for long

- term exposure, effects in kidney
are more sensitive endpoints. Thus, staff chose the study of effects in kidney for the dose

response analysis and derivation of the chronic duration ADI

.

Comment

If long

- term and intermed iate

- term LOAELs and NOAELs are similar , what does this mean for
the minimum exposure period needed to produce a long

- term effect?

Response: The available information indicates that the relationship between cadmium exposure

and adverse health effects is co mplex, with considerable variability in responses

, depending on
dose, route of administration or exposure, and species or strain of animal or human population.
Further, there are a variety of endpoints for cadmium toxicity, each with its own dose

- response relationship. Many effects of cadmium are observed only at relatively high exposure levels,
regardless of duration of exposure

. O ther effects have been seen following longer term exposures at lower levels, such as the adverse effects in kidney and bone that are the most
significant and most sensitive endpoints for chronic exposures. The results of studies in
experimental animals that show, in some cases, similar LOAELs and NOAELs in intermediate or
longer term studies may be due to the specific endpoint s considered in the studies, or the specific
conditions of the studies, such as choice of species. However, the data do not provide for a clear
conclusion to be made about the minimum exposure period needed to produce a long

- term effect.

Comment

The appli cation of the default uncertainty factor in the derivation of the chronic ADI could be
reconsidered. Based on the large size of the populations included in the epidemiological studies,
a factor of 3 would be appropriate. However, some remaining uncertain ty, such as the possibility
of effects of childhood exposure to cadmium, should be discussed.

Response : Staff agrees that the database for chronic exposure to cadmium is robust, and that
uncertainty can be characterized using a factor of 3, rather than the default value of 10

, to account for effects in sensitive subpopulations. Although children have not been specifically
studied with respect to adverse effects from long

- term exposure to cadmium, the epidemiological
studies included populations with genera l environmental exposures to cadmium that likely

occurred throughout their lives, including during childhood . Therefore, the results of those
studies would, in part, reflect childhood exposure.

### 17 

## Comment

CPSC staff should m odel short

- term exposure and deriv e ADI based on effects on cadmium
concentration in the kidney.

Response : At this time, the staff does not believe that such an analysis, using available
information, would significantly reduce the uncertainties related to data on short

- term exposures.

How ever, staff agrees that the approach to the short

- term exposure data in the draft document is
inadequate, and has revised the evaluation using information from published studies of acute
exposure in experimental animals.

Comment

The approach to the swallow ing scenario does not make sense and is not appropriate.

Response : S taff’s approach to evaluating the acute exposure scenario was developed because of
the lack of data specific to acute exposure to cadmium, particularly from foreign body ingestion,

such as swallowing jewelry. S taff has reconsidered th is approach and made appropriate changes
to the report

. S taff is now using published studies of acute exposure in experimental animals for
the swallowing scenario assessment.

Comment

An acute exposure limit is needed. Reevaluate the available acute data or use an intermediate
duration limit. Provide more details about the acute exposure data, including GI effects.

Response : S taff agrees that an acute exposure limit is needed. While staff still considers t he
available database on effects from acute exposures to be limited, t his section of the report was
revised to include information from published acute exposure studies in experimental animals.

Comment

How might the acute and chronic mechanism s of action d iffer ?

Response : The toxicological effects of cadmium are many, and depend on dose, form

, and
route of exposure, whether the effect is observed in humans, and the species and strain of animal
used in experimental studies. S ystemic effects (multiple orga ns and tissues) are observed from

both acute a nd chronic exposures

. Acute exposures often involve higher exposure levels, which
may result in effects that are not observed with lower dose, longer term exposures ( e.g. , effects
directly on gastrointestinal tissue that are related to high doses). Some actions of cadmium
would be expected to occur regardless of the duration of exposure; s ome effects involving certain
biological systems or processes may occur only after longer term exposures because repeated

e xposures over time are required to perturb the systems

. Thus, acute and chronic toxicity may

share certain mechanisms , depending on dose and other factors of exposure, while some
mechanisms are relevant only with longer

- duration exposure.

Comment

A commen ter suggested that staff consider recent data that show increased urinary excretion of
cadmium in children age s 6 through 11 years, as well as for females, which could indicate
important differences in exposure and uptake of cadmium in these populations.

R esponse : S taff added discussion to the report, but because staff’s analysis is based on a study in
women who likely also had been exposed in childhood, the conclusions have not changed.

### 18 

## Although uncertainty remains on the implications of possible differen ces among various groups of people, the relatively large body of literature concerning long

- term exposure and effects of
cadmium supports the approach taken by staff

.

Comment

I t appears that the CPSC is deriving a different (higher) ADI than the ATSDR chro nic MRL or

USEPA RfD

. Response : As described in the draft document , CPSC staff derived an oral, chronic ADI that is
lower than either the existing or draft MRL derived by the ATSDR

, or the existing RfD derived
by the EPA. The difference between the CPSC s taff’s draft ADI and the EPA’s RfD stems from
using different epidemiological studies as the basis for the analysis. Similar data were used to

estimate the ADI in CPSC staff ’s draft analysis and the ATSDR’s draft, but CPSC staff applied
an uncertainty fac tor of 10 to account for sensitive members of the population, while the ATSDR
used a factor of 3. ADI estimates are divided by uncertainty factor s, so that using a factor of

10 results in a lower estimated ADI. Based on the peer review comments and addit ional
consideration of this issue, the revised CPSC staff analysis includes an uncertainty factor of

3 rather than the default value of 10 ( to account for effects in sensitive subpopulations ) because
of the strength of the numerous epidemiological studies. Therefore, staff’s revised ADI is the

same as the ATSDR’s draft chronic MRL.

Comment

Are there data specifically on ingestion of jewelry regarding GI transit time?

Response : The CPSC databases allow estimates of the number of cases involving ingestion o f
jewelry, but few cases , if any, provide details about the incidents, such as GI transit time

. The
scientific literature discusses cases of foreign body ingestions, but jewelry ingestions have not

been considered specifically , and the cases that have bee n reported are not well

- described.

Comment

The dose associated with emesis should not be normalized to body weight; volume of stomach
contents would be a more appropriate measure for extrapolation to different ages.

Response : The staff agrees with this co mment, and revised the description of the data
accordingly.

Comment

For the mouthing scenario, an intermediate duration exposure limit would be more appropriate.

Response : The staff used data from studies in humans to derive the exposure limit for longer

t erm exposures. An intermediate duration study, conducted in animals, was not chosen for use in
the assessment because data in humans, when available, is preferable to animal studies

. In

addition , in this case

, the numerous

, well

- conducted studies in huma ns

, lead to a high er level of

confidence in the results than would occur using the study in animals.

### 19 

# TAB B: Toxicity Review of Cadmium 

# T

A

B

B

## U NITED 

## S TATES



## C ONSUMER 

## P RODUCT 

## S AFETY 

## C OMMISSION



## B ETHESDA 

## , MD 20 814

Memorandum

CPSC Hotline: 1

- 800

- 638

- CPSC (2772) CPSC's Web Site: http://www.cpsc.gov 

## Date: October 14, 2010

TO : Mary Ann Danello, Ph.D., Associate Executive Director, Directorate for Health

Sciences

THROUGH : Lori E. Saltzman, M.S., Director, Division of Health Sciences

FROM : Dominique J. Williams, Toxicologist, Division of Health Sciences
Kristina M. Hatlelid, Ph.D., M.P.H., Toxicologist, Directorate for Health

Sciences

SUBJECT : Toxicity Review of Cadmium 1



## This memo randum provides the U.S. Consumer Product Safety Commis sion’s (CPSC) Health
Sciences staff assessment of the potential toxicity associated with cadmium and cadmium

containing compounds

. CPSC staff assesses a product’s potential health effects to consumers under the Federal
Hazardous Substances Act (FHSA). The FHSA is risk

- based. To be considered a “hazardous
substance” under the FHSA, a consumer product must satisfy a two

- part definition. 15 U

. S

. C

. § 1262 (f)(1)(A). First, it must be toxic under the FHSA, or present one of the other hazards

enumerated in the statute. Second, it must have the potential to cause “substantial illness or
injury during or as a result of reasonably foreseeable handling or use.” Therefore, exposure and
risk must be considered in addition to toxicity when assessing potential hazards under the FHSA

(CPSC , 1 992; summarized at 16 C.F.R. § 1500.135)

.

The FHSA addresses both acute and chronic hazards. While the FHSA does not require
manufacturers to perform any specific battery of toxicological tests to assess the potential risk of

chroni c health hazards, the manufacturer is required to label a product appropriately according to
the requirements of the FHSA. The first step in the risk assessment process is hazard

identification

, that is, a review of the available toxicity data for the che mical under consideration

and a determination of whether the chemical is considered “toxic” under the FHSA. Chronic
toxicity data (including carcinogenicity, neurotoxicity, and reproductive and developmental
toxicity) are assessed by CPSC staff using guid elines issued by the Commission (CPSC , 1 992). If it is concluded that a substance is toxic under the FHSA due to chronic toxicity, then a
quantitative assessment of exposure and risk is performed to evaluate whether the chemical may

be considered a “hazar d ous substance” under the FHSA.

1 These comments are those of the CPSC staff and have not been reviewed or approved by, and may not necessarily reflect the

views of, the Commission.21 

## This memo represents the first parts of the risk assessment process

, that is , the hazard

identification and dose

- response steps

.

S taff’s conclusion is that the data concerning the toxicity of cad mium , discussed below, are

su fficient for cadmium to be considered toxic under the FH S A due to effects on multiple organ
systems and toxic endpoints, including kidney dysfunction.

S taff has developed an acceptable daily intake level ( ADI ) for chronic exposure to cadmium by

the oral ro ute of 0. 1 micrograms cadmium per kilogram body weight per day (0.1 μg /kg/day )

based on studies in human populations. This is the level of chronic exposure that should not be

exceeded in order to avoid health effects.

Introduction

Cadmium is a metal found in the earth’s crust, and is known to be associated with zinc, lead, and
copper ores. Pure cadmium is a soft, silvery

- white metal that is insoluble in water; soluble forms

include cadmium chloride and cadmium sulfate. Most cadmium used in the United Sta tes comes from the processing of other metals, such as lead, as well as recycling of nickel

- cadmium
batteries. According to Agency for Toxic Substances and disease Registry’s Draft Toxicological

Profile for Cadmium ( ATSDR , 2 008), approximately 83 percent of cadmium is used in batteries.

For nonsmokers, the primary source of cadmium is food. Those regularly consuming shellfish
and organ meat have higher exposures. Leafy vegetables also contain high levels of cadmium.

T obacco leaves accumulate cadmium fro m the soil , leading to increased cadmium exposure
among smokers (ATSDR , 2 008).

Blood cadmium concentrations reflect recent and cumulative exposures; urinary cadmium levels
reflect both cadmium exposure and the concentration of cadmium in the kidneys. As p art of its
National Health and Nutrition Examination Survey (NHANES), the Centers for Disease Control
and Prevention (CDC) measured cadmium in the blood and urine of a representative sample of

the U

. S

. population. From the 2003

– 2004 survey (CDC , 2 009), t h e geometric mean blood and

urine cadmium levels for the group 20 years of age and older was 0. 378 micrograms per liter

( μg/L ) in blood and 0.2 60 μg/L in urine . Females (0.326 μg/L, blood; 0. 216 μg/L

, urine) had
slightly higher levels than males (0.283 μg/L, blood; 0.206 μg/L, urine).

Several agencies have established recommendations or regulations for cadmium

. T he U.S.

En vironmental Protection Agency (EPA) developed an oral reference dose (RfD 2

2 The EPA’s RfD is defined as an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the
human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects duri ng a
lifetime. 

## ) of 1 μg/kg/day for food intake and 0.5 μg/kg/day for cadmium in drinking water (different levels of
absorption of cadmium from food or from water account for the different RfD valu es ) (EPA

, 1 994) and has established limits for cadmium concentration in drinking water of 0.04 mg/L for
exposures up to 10 days, or 0.005 mg/L for lifetime exposures (EPA , 2 003)

. The U.S. Food and
Drug Administration (FDA) established the limit for cadmiu m in bottled water at 0.005 mg/L

(FDA , 2 009) . For exposure through inhalation in the workplace, the Occupational Safety and

Hea lth Administration (OSHA) established a limit of 5 micrograms per cubic meter of air (5
μg/m 3 

## ) for an 8

- hour workday (OSHA , 2 009 )

.22 

## The ATSDR ’s 2008 draft toxicological profile includes a minimal risk level (MRL 3 

## ) for chronic 4



## Toxicokinetics oral exposure of 0. 1 μ g/kg/day , based on kidney effects in humans (AT SDR , 2 008). The draft
toxicological profile also includes an MRL for intermediate length exposure of 0.5 μg/kg/day
based on effects on bone in experimental animals. Due to inadequacies in the acute oral
exposure database, ATSDR has not derived an acute duration MRL.

Cadmium is not well absorbed into the body, especially after ingestion or through the skin. After
absorption, cadmium is widely distributed throughout the body, but is predominantly found in
the liver and kidney. Excretion is very slow, with approximately 0.007 and 0.009 percent of the
body burden being excreted in the urine and feces, respectively, per day (ATSDR , 2 008).

Absorption

Based on a number of studies, the ATSDR (2008) reported that absorption from oral exposure
likely ranges between 1 and 10 percent. While e xposures through inhalation are important in the
workplace, inhalation exposures are less likely from consumer products than exposures through
ingestion of cadmium

- containing substances and products.

All of the studies reviewed suggest that the absorption of cadmium via the dermal route is slow.

Les s than 1 percent of the administ e red dose is absorbed through the skin during dermal
exposures. Dermal absorption generally would be a concern when solutions c o me into contact
with the skin for several hours or more, such as in an occupational setting (AT SDR , 2 008).

Distribution

Cadmium can be de te cted in all tissues, with the largest concentrations in the liver and the
kidney s . Kjellström (1979) presented data from an international investigation of cadmium

exposure. In this study, a nalysis of tissues f rom hundreds of people in Japan, Sweden

, and the

U nited S tates showed geometric mean concentrations in the kidney s and liver increased from
less than 1 microgram per gram tissue weight (1 μg/g ) in early childhood to a peak of 40

– 50 μg/g
in the kidney

, and 3

– 4 μg/g in the liver that occurs at around 50 to 60 years of age. After about
age 60, tissue cadmium concentrations decrease over time.

Metabolism

After absorption, cadmium does not unde rgo direct metabolic conversion such as oxidation,
reduction, or alkylation. However, the cadmium ion binds to proteins and other molecules,
especially the proteins albumin and metallothionein (Nordberg , 1 984). Cadmium in the blood is

found primarily in protein complexes.

Elimination

Kjellström and Nordberg ( 1978, 1985) studied the available data and developed a human
toxicokinetic model for cadmium to describe cadmium absorption, distribution, and excretion.

Based on the available data, cadmium excreted from the body in feces is largely unabsorbed
material from the gastrointestinal tract

. Most of the cadmium that is absorbed into the body is

3 The ATSDR’s MRL is an estimate of the daily human exposure to a ha zardous substance that is likely to be without appreciable
risk of adverse noncancer health effects over a specified duration of exposure

.

4 As defined in the ATSDR toxicological profiles, chronic exposure is exposure to a chemical for 365 days or more; intermediate
exposure is 15 through 364 days; acute exposure is through 14 days.23 

## excreted slowly, with urinary and fecal excretion being approximately equal . U rinary excretion
is dependent on b lood and kidney concentrations, and the total excretion is assumed to be equal
to the daily intake of cadmium at steady state.

From the model, these authors estimated that daily excretion in feces and urine is approximately

0.007 and 0.009 percent of bod y burden , respectively. The model also predicts that the half

- life
for cadmium in human tissue is in the range of 6 to 38 years in the kidney and 4 to 19 years in

the liver.

Acute Toxicity

Investigation of suicide involving c admium ingestion found that de ath occurred due to massive
fluid loss, edema, and widespread organ destruction. Buckler et al. ( 1986 ) described a case of an
estimated exposure of 1,840 mg/kg cadmium chloride that resulted in death with in 33 hours.

Wisniewsk a

- Knypl et al. ( 1971) report ed death within 7 days of ingestion of 25 mg/kg cadmium

iodide

. In a less severe case of acute toxicity, Nordberg et al. (1973) reported gastrointestinal effe cts in
children who ingested 16 mg/L cadmium from soft drinks. This case involved gastrointesti nal
symptoms in boys 13 to 15 years old following ingestion of a beverage containing 16 milligrams
cadmium per liter of beverage (16 mg/L). Based on information collected from the boys about
five months after the incident, symptoms began within 15 minutes of consumption of the drink,
and included headache, nausea, vomiting, abdominal pain, and diarrhea. All symptoms resolved
within seven hours, and most of the boys returned to school when classes resumed three days

later. The childre n reported consuming 0 .5 to 2.5 glasses of the drink , with an average of about
one glass. A lthough the volume of beverage consumed was not reported , information in the
publication’s discussion suggests that the investigators considered a glass to be about 0.15 L.

Studies in experimental animals show that t he oral LD 50 5



## Systemic Toxicity range s from approximately 100 to

300 mg/kg in rats and mice (Baer and Benson , 1 987; Kostial et al. , 1 978; Kostial et al. , 1 97 9 ).

The lowest dose of cadmium found to cause death (2 of 20 animals) was 15.3 mg/kg
administered as cadmium chloride in water in a single dose by gavage in Sprague

- Dawley rats
(Borzelleca et al. , 1 989). Other adverse effects from acute oral exposure include : reduced body
weight or reduced body weight gain (cadmium doses greater than abo ut 2 mg/kg/day) ; hemorrhages, ulcers, and reddening of the stomach and intestinal tract (61 mg/kg/day) ; testicular
atrophy (66 mg/kg/day) ; and necrotic changes in the kidney (15.3 mg/kg/day) and liver

(138 mg/kg/day) (Baranski , 1 985; Borzelleca et al. , 1 98 9 ; Machemer and Lorke , 1 981).

Ingestion of cadmium is associated with numerous effects, primarily in the kidney and bone.
The main effects and key studies are summarized below.

Kidney

The adverse effects of cadmium in the kidney are rela ted to the concentration of cadmium within
the kidney, particularly within the kidney cortex. Studies have been conducted using kidney
cortex cadmium concentration as the measure of exposure. Because the concentration of
cadmium in the kidney is associat ed with the concentration of cadmium in the urine, the latter

5 LD 50 , or lethal dose

- 50, is the dose that produces death in half of the group of test animals under specified conditions and test

duration.24 

## metric has been used in studies of living humans, in which kidney levels of cadmium cannot be
directly measured.

Tubular dysfunction is considered one of the first signs of kidney damage, charac terized by an
increase in urinary

, low

- molecular

- weight protein excretion

, such as β2

- microglobulin (β2M),
human complex

- forming glycoprotein (pHC) (also known as α1

- microglobulin(α1M)), and
retinol binding protein; or increased levels of intracellular enz ymes

, such as N

- acetyl

- β

glucosaminidase (NAG) in the urine (European Chemicals Bureau , 2 007; Järup et al. , 1 998).

Exposure at higher levels is associated with e xcretion of high

- molecular

- weight proteins, such as

albumin , as demonstrated in studies of w orkers with exposure by inhalation (Bernard et al.

, 1 979, 1990; Chen et al. , 2 006a, 2006b; Elinder et al. , 1 985; Roels et al. , 1 989, 1993; Thun et al.

, 1 989).

In workers exposed to high levels of cadmium, ending exposure does not usually lead to the

revers al of the damage affecting th e kidney. The increases in urinary levels of β2M, retinol
binding protein, or total protein

, or the decreases in glomerular filtration rate ( GFR ) have been
seen years after the cadmium exposure in workers ended (Elinder et al. , 1 985; Järup et al. , 1 993;

M ason et al. , 1 999; Piscator , 1 984; Roels et al. , 1 989; Thun et al. , 1 989). For workers with low exposure levels of cadmium, decreases or no change in urinary β2M levels were seen after
exposure ended (McDiarmid et al. , 1 997; van Sittert et al. , 1 993). Ro els et al. (1997) and

Trzcinka

- Ochocka et al. (2002) found that reversibility of cadmium

- induced tubular dysfunction
was dependent on the cadmium body burden and the severity of microproteinuria at the time

cadmium ex posure was reduced or stopped.

A number of large epidemiological studies have examined the effects of cadmium exposure on
the kidney. A few such studies are summarized here.

Järup et al. (2000) examined 1,021 individuals living near a nickel

- cadmium battery plant in

Sweden for at least five ye ars (n=799) or employed as battery workers (n=222). The mean urinary cadmium levels were 0.81 and 0.65 μg/g creatinine 6



## The European Chemicals Bureau (2007) recalculated the probability of pHC proteinuria (using
the raw data from Järup et al. , 2 000) to account for the differences in age of the reference
population (mean of 40 years) and study population (me an of 53 years). Based on these
recalculations, the urinary cadmium level associated with a 10 percent increased probability of
abnormal pHC values (20 percent total probability) was 2.62 μg/g creatinine for the total
population. In the nonworker subgrou p, a urinary cadmium level of 0.5 μg/g creatinine was

associated with a 13 percent probability ( representing a doubling of the probability for the
reference popul ation) of abnormal pHC values. in males and females, respectively.
Urinary cadmium levels were significantly associated with urinary pHC levels, after adjustment

for age , in the whole study population

, or with the workers removed from the analysis. The
prevalence of abnormal pHC values (defined as exceeding the 95th percentile in a Swedish
reference population ) was estimated to increase by 10 percent at urinary cadmi um lev els of

1 μg/g creatinine.

6 M easurement of creatinine levels in the urine or blood is used to evaluate kidney function. Urinary protein measurements are

often normalized to creatinine to account for t he variations in excretion of urine and allow comparison of urinary measurements
over time, between subjects, or from different studies.25 

## Noonan et al. (2002) examined 361 residents in Pennsylvania liv ing near an old zinc smelting facility (geometric mean urinary cadmium level of 0.14 μg/g creatinine) and a reference
community (without an identified exposure source) located 10 miles from the facility (geometric

mean urinary cadmium levels of 0.12 μg/g c reatinine). The data from the two communities were pooled because there were no differences in urinary cadmium levels between them. β2M, NAG,
alanine aminopeptidase (AAP), and albumin (ALB) levels were measured as biomarkers of renal
dysfunction. The ge ometric mean urinary cadmium levels were 0.07 and 0.08 μg/g creatinine in
88 males and 71 females age s 6 to 17 years old

, and 0.24 and 0.23 μg/g creatinine in 71 males
and 80 females aged ≥18 years. No significant correlations between urinary cadmium level s and
renal biomarkers were observed in the children, after adjustment for creatinine, age, and gender.
In adults, significant correlations (after adjustment for creatinine, age, gender, smoking, and self

reported diabetes or thyroid disease) between urin ary cadmium and NAG (partial correlation

coefficient of 0.20, 95% CI of 0.05

– 0.36) and AAP (partial correlation coefficient of 0.21 and

95% CI of 0.05

– 0.36) were observed. Significant dose

- effect relationships also were found for

these two biomarkers. Ur inary cadmium levels were not significantly associated with elev ated levels of β2M or ALB.

Jin et al. (2002) examined three populations living various distances from a nonferrous metal
smelter. The geometric mean levels of urinary cadmium were 11.18 and 1 2.86 μg/g creatinine in males (n=294) and females (n=171) in the highly polluted area, 3.55 and 4.45 μg/g creatinine in males (n=243) and females (n=162) in the moderately polluted area, and 1.83 and 1.79 μg/g

creatinine in males (n=253) and females (n=155 ) in the control area. Significant correlations were found between urinary (and blood) cadmium levels and renal biomarkers (β2M, retinol
binding protein, and ALB).

Dose

- Response Relationships for Effects in Kidney

Several dose

- response analys e s have been done using a number of studies, including those

summarized above, investigating the relationship between adverse effects in the kidney and
urinary cadmium levels as a biomarker of cadmium concentration in the kidney.

Investigators analyzed data involving hundreds of people from studies in Europe ( Järup et al

. , 2 000 ; Suwazono et al. , 2 006) , Japan (Kobayashi et al. , 2 006; Shimizu et al. , 2 006 ; Uno et al.

, , 2 005)

, and China (Jin et al. , 2 004) . The study populations lived in cadmium

- polluted areas or
had no p articular source of cadmium exposure. Several studies used benchmark dose 7



## In a population of workers and environmentally exposed people in Europe, J ärup et al

. ( 2000 ) found a 10 percent excess in urinary pHC at a cadmium concentration 1.0 μg/g creat. approach es to estimate critical exposure levels. Most of these studies considered urinary

excretion of pHC, NAG, β2M, retinol binding protein, ALB, or other proteins

, and markers for
changes in GFR as biomarkers of kidney injury

. The analyses differed in choice of study
population and also in the choice of model and parameters resulting in estimates of critical
urinary cadmium concentrations ( i.e. , the cadmium concentration associ ated with a specified
level of risk for kidney dysfunction) ranging from about 0.3 to 15 micrograms cadmium excreted
in urine per g ram creatinine in urine ( μg/g creat). These studies are summarized below.

Jin et al. ( 2004 ) examined a population living in a cadmium

- contaminated area of China. Using a benchmark dose approach and cutoff value for defining abnormality for excretion of β2M of

7 A benchmark dose approach uses mathematical modeling to characterize exposure

- response relationships.26 

## 0.8 mg/g creat., these researchers estimated a critical cadmium concentration of about 4 to

15 μ g/g creat. for a 5 percent excess risk.

In a n analysis of data collected in a region of Japan without a source of cadmium pollution,
Kobayashi et al. ( 2006 ) estimated a critical cadmium concentration for a 5 percent excess risk of

about 2

- 4 μg/g creat.

Shi mizu et al. ( 2006 ) analyzed people living in a cadmium

- contaminated area of Japan. Using a benchmark dose approach and cutoff value for defining abnormality for excretion of β2M of

1 mg/g creat., these researchers estimated a critical concentration betwee n 1 μg/g creat. and

4 μg/g creat.

Suwazono et al. ( 2006) used data from a study of Swedish women who had no particular
environmental or occupational exposure to cadmium. Using a benchmark dose approach, and a

cutoff based on the 95 th 

## percentile for urin ary protein excretion estimated for a person with no
cadmium exposure, the critical concentration was estimated at 0.6

- 1 μg cadmium/g creat. for a

5 percent excess risk based on excretion of NAG and pHC.

Another study in Japanese populations not exposed to a known source of cadmium resulted in an

estimated critical concentration of 0.3

- 3 μg cadmium/g creat. ( Uno et al. , 2 005 ).

Another analysis of several studies conducted mostly in Japanese populations was cond ucted by

Gamo et al. (2006) , with a focus on st udying the effects of age and sex. Urinary cadmium was used as a biomarker of exposure and the prevalence of abnormal levels of β2M as an indicator of
kidney dysfunction. The authors concluded that a significant increase in the prevalence of abnormal β2M levels would not result if the geometric mean urinary cadmium level in a nationwide population does not exceed 2 μg/g creat.

Diamond et al. (2003) considered data from 15 different epidemiological studies . These authors
developed a pharmacokinetic/pharma codynamic (PK/PD) model to determine the relationship of
low molecular weight (LMW) proteinuria with cadmium exposure. T he authors estimate d tissue
cadmium concentrations, rather than using cadmium excretion in the urine as a marker of dose,

and estimated intake levels corresponding to the specified probabilities of observing LMW proteinuria in a model of a 55

- year

- old person

. The analysis resulted in an estimate for 10

percent risk for LMW proteinuria with a median kidney cortex concentration of 153 μg c admium
per gram tissue, corresponding to a cadmium intake of 2 μg/kg/d ay in females and 4.3 μg/kg/d ay
in males.

Liver

While liver tends to accumulate cadmium

, it does not appear to be as sensitive to cadmium
effects as the kidney.

The two cases involving d eath in humans discussed above ( Buckler et al. , 1 986 ; Wisniewsk a

Knypl et al. , 1 971) included liver injury ; but studies of lower doses in human have not shown
significant liver

- specific effects (Ikeda et al. , 1 997, 2000).

In experimental animals, exposure in rats for 10 days to drinking water containing

13.9 mg /kg/day was not associated with liver effects, while a dose of 138 mg/kg/day caused
severe effects, including necrosis of hepatocytes (Borzelleca et al. , 1 989). Longer term studies

have shown liver e ffects at lower doses. A 10

- week study in male Rhesus monkeys at a dose of
4 mg/kg/day by gavage found decreased glutathione peroxidase and glutathione S

- transferase27 

## (GST) activity in the liver and other tissues (Sidhu et al. , 1 993). A number of other st udies have
noted histopathologic changes in the liver and changes in liver

- associated enzymes in other
laboratory animals at doses as low as about 2 mg/kg/day (Groten et al. , 1 990; Müller and Stacey

, 1 988; Schroeder et al. , 1 965; Steibert et al. , 1 984; Sto we et al. , 1 972). Other studies with similar
doses did not observe liver effects (Loeser and Lorke , 1 977a; Kotsonis and Klaassen , 1 978).

Musculoskeletal Toxicity

Cadmium effects on the bone in humans are evident in a cadmium

- contaminated area in Japan

, wh ere some residents suffer from a disease known as Itai

- Itai or “ ouch

- ouch ” disease involving
osteoporosis and osteomalacia

.

In a study of a population of Swedish men and women living in an area with past sources of
cadmium pollution, significant decrease s in bone mineral density were observed in the group

more than 60 years of age with the highest blood cadmium levels compared to lowest exposed

group (Alfvén et al. , 2 002). Åkesson et al. (2006), i n a study of Swedish women without a
particular expos ure t o cadmium, reported a significant negative relationship between urinary

cadmium levels and bone mineral densi ty. The median urinary cadmium concentration was

0.67 μg/g creat. in this population. These two study populations also were used to examine the

r elationship between cadmium exposure and kidney toxicity (see above).

A study in a group of Flemish women ( Schutte et al. , 2 008) showed effects on several measures
of bone health in the absence of evidence of kidney dysfunction in most of the subjects

.

I n an analysis of women in the U nited S tates

, Gallagher et al. (2008) used data from the Third

U

. S

. National Health and Nutrition Examination Survey (NHANES) 1988

– - 1994 , as well as

NHANES 1999

– - 2004

, to evaluate the association of urinary cadmium levels and osteoporosis

. These researchers reported that women who were at least 50 years of age with urinary cadmium

levels between 0.50 and 1.00 μg/g creat.

, were at 43 percent greater risk for osteoporosis, relative
to those with levels less than or equal to 0.5 0 μg/g creat. Because smokers did not show a
statistically increased risk, the authors concluded that dietary sources of cadmium, rather than
cigarette smoke, are related to the osteoporosis risk. These authors also conclude d that perhaps

21 percent of o steoporosis prevalence among women at least 50 years of age may be attributed to

cadmium.

Recently, Suwazono et al. (2010), following their analysis of kidney effects in a population of

Swedish women, looked at cadmium

- induced bone effects. Using the benc hmark dose ap proach,

these researchers estimated the critical cadmium concentration of 1.8

- 3.7 μg/g creat. for a

5 percent excess risk of low bone mineral density. The lower confidence limit of the critical

cadmium concentration (BMDL) is 1.0

- 2.1 μg/g creat.

Brzóska a nd colleagues published a series of studies demonstrating effects of cadmium on bone
in experimental animals ( Brzóska and Moniuszko

- Jakoniuk , 2 004a, 2004b, 2005a, 2005b, 2005c

, 2005d; Brzóska et al

. , 2 004, 2005a, 2005b, 2005c ) . Osteopenia and osteoporosis were noted in
male rats exposed for 12 months to cadmium at 0.5 mg/kg/day and 4 mg/kg/day , respectively. In
female rates, osteopenia was reported after expos ure at 0.08 mg/kg/day for 12 or 18 months , and
osteoporosis was observed with exposed at 0.08 mg/ kg/day for 24 months

. Altered mechanical
properties of bone also were observed by these researchers and others ( Ogoshi et al. , 1 989 ). A
number of studies reported d ecreased bone calcium and increased urinary excretion of calcium in

intermediate

- and chro nic

- duration studies with doses of 0.2

– 8 mg/kg/day (Brzóska and28 

## Moniuszko

- Jakoniuk , 2 005d; Kawamura et al. , 1 978; Nogawa et al. , 1 981; Pleasants et al. , 1 992;

Watanabe et al. , 1 986).

Reproductive Toxicity

Several studies investigated the relationships betw een cadmium in blood, serum, or semen and
hormone levels ( testosterone, follicle stimulating hormone, luteinizing hormone, prolactin,

estradiol ) and measures of fertility. In a study of Eastern European men, Jurasović et al. ( 2004 )
reported a number of si gnificant associations between reproductive health endpoints and
cadmium blood concentrations, after adjusting for smoking status. Akinloye et al. ( 2006 ) also
reported significant relationships between physical measures of decreased fertility and blood

se rum cadmium measurements. Seminal plasma cadmium concentration was not associated with
the fertility outcomes. For hormone measurements, only seminal plasma cadmium concentration
had a significant effect, and only for follicle stimulating hormone levels. In a study of men in the

U nited S tates , using data from the third National Health and Nutrition Examination Survey

(NHANES III), Menke et al. (2008) reported no association between urinary cadmium levels and

serum testosterone and estradiol levels , after adjusting for smoking status

. No studies were found on reproductive effects in women after oral exposure to cadmium.

Several studies in experimental animals considered reproductive effects of cadmium exposure.

Borzelleca et al. (1989) noted testicula r atrophy in rats after exposure to 66 mg/kg/day by gavage
for 10 days. A single dose of up to 25 mg/kg in rats had no effect (Dixon et al. , 1 976). Longer

term studies ( up to 17 weeks) in rats showed testicular effects with doses of about 5

– 12 mg/kg/day ( Pleasants et al. , 1 992; Pleasants et al. , 1 993 ; Saxena et al. , 1 989 ).

In studies of female animals, no effects on reproductive organs were noted in rats after exposure
up to 138 mg/kg/day by gavage for 10 days ( Borzelleca et al. , 1 989) . Baranski and Sita rek
(1987) observed a significant increase in the duration of the estrous cycle in rats administered

40 mg/kg by gavage 5 days/week for 14 weeks.

A two

- generation study involving male and female rats exposed to 2.5 mg/kg/day in drinking
water for 180 days showed decrease d litter size and increased interval between litters, and failure

to breed in three of five second

- generation pairs (Schroeder and Mitchener , 1 971).

Developmental Toxicity

Several studies have considered the possible effects of cadmium expos ure on pregnancy and
offspring in humans. Salpietro et al. ( 2002) reported a significant association between cord

blood cadmium levels and decreased newborn birth weight in a small study of women with
relatively low cadmium exposures. Nishijo et al. (200 2) reported decreased birth weight,
probably secondary to early delivery, associated with maternal urinary cadmium levels. Zhang

et al. ( 2004 ) reported an association between cord blood cadmium level and infant height, but
not weight, or other pregnancy o utcomes. These and other similar studies involved small
numbers of participants, and did not control for confounding factors that might also be related to
pregnancy outcomes, resulting in limited evidence of a causal relationship between cadmium

exposure and pregnancy outcomes.

Numerous studies in experimental animals provide clearer evidence for developmental toxicity.
Several studies reported reduced fetal or pup weight and increased incidence of skeletal

malformations, missing internal organs or tissu e

, failure of testes to descend, and cleft palate in29 

## offspring of mothers exposed to cadmium at doses of about 1

– 20 mg/kg/day (Ali et al. , 1 986 ;
Baranski , 1 985; Baranski , 1 987 ; Machemer and Lorke , 1 981; Schroeder and Mitchener , 1 971)

. In multigenerational studies of rats, Nagymajtenyi and colleagues reported that cadmium

administration of 7

– 14 mg/kg by gavage during pregnancy, lactation, and after we a ning resulted
in significant behavioral and electrophysiological effects in the offspring (Nagymajtenyi et a l.

, 1 997; Desi et al. , 1 998).

In a study in rats, Saxena et al. (1986) reported no developmental effects from exposure to either
cadmium acetate (21 mg/kg/day as cadmium in drinking water) or lindane (20 mg lindane/kg by
gavage), when administered alone dur ing gestation. Coexposure to cadmium and lindane
resulted in maternal toxicity and developmental toxicity. Effects in the dams included decreased
weight gain; developmental effects included decreased fetal body weight, increased intrauterine

death, an d skeletal anomalies.

Neurologic Toxicity

A few studies have evaluate d neurological effects from cadmium exposure. Based on analysis of

metal content of hair, Thatcher et al. ( 1982) and Marlowe et al. ( 1985) reported associations
between cadmium exposur e and measures of intelligence or behavior. Because of shortcomings,
including lack of control for confounding factors, such as exposure to lead, and inadequate
assessment of cadmium exposure, the significance of these studies is unclear.

In studies in ex perimental animals, in both short

- term and long

- term studies with doses ranging

from about 1 t o 5 0 mg/kg/day , a number of neurologic endpoints, including decreased motor
activity

, weakness and muscle atrophy , increased aggressive behavior , increased passiv e
avoidance behavior , and other changes in certain cells and enzyme levels have been observed
(Baranski and Sitarek , 1 987 ; Kotsonis and Klaassen , 1 977 ; Kotsonis and Klaassen , 1 978; Murthy

et al. , 1 989 ; Nation et al. , 1 984 ; Nation et al. , 1 990; Sato et al.

, 1 978 ; Valois and Webster

, 1 989).

Carcinogenicity

The carcinogenicity of cadmium and cadmium compounds has been evaluated largely in
populations exposed through inhalation in workplace settings. Although deficiencies exist in the

available information, th e evidence supports the relationship between inhalation of cadmium and

cancer (see ATSDR

, 2008 for review of inhalation exposure studies). Cadmium and cadmium
compounds are listed as “known to be human carcinogens” in the Report on Carcinogens, largely

ba sed on studies in workers (NTP , 2 005).

A few investigations also have considered the relationship between cancer and oral exposure to

cadmium in humans

. Studies of populations in areas with known cadmium sources have not
found significant associations wit h cancer (Bako et al. , 1 982; Hardell et al. , 1 994; Inskip et al.

, 1 982; Lauwerys and De Wals , 1 981; Nakagawa et al. , 1 987 ; Shigematsu , 1 984 ). Some of these
studies had methodological shortcomings or lacked statistical power to show effects, if such

effect s exist.

Studies in experimental animals and in vitro studies show that cadmium may have effects that

could be associated with cancer. Kurokawa et al. (1989) , in a study investigating whether certain
metal compounds act as promoters of tumors initiated by other chemicals, reported that cadmium
exposure at 61 ppm in drinking water did not affect the incidence of renal cell tumors, but was30 

## associated with increased numbers of dysplastic foci in the kidney. These authors also reported

that cadmium chloride d id not act to increase tumors in the liver, stomach, pancreas, or skin.

In a study investigating cadmium carcinogenesis and dietary zinc deficiency in rats, Waalkes and

Rehm ( 1992) reported a number of effects of exposure to cadmium in the diet at 0, 25, 50, 100,
or 200 ppm for 77 weeks. The incidence of prostate tumors was slightly increased compared to

controls at 50 ppm, but not the other dose groups. An increase in testicular tumors was noted
only in the highest dose group that also received adequat e levels of zinc, but not in groups that

were fed the zinc

- deficient diet. Leukemia incidence also was increased in the cadmium

exposed groups. The authors conclude that cadmium is associated with the incidence of tumors
in exposed animals, and that diet ary zinc deficiency has a complex, inhibitory relationship in
cadmium carcinogenesis.

Although cadmium exposure carcinogenesis is not clearly shown in the human and animal

studies , recent work in vitro provides evidence that cadmium exposure could be relat ed to

cancer. Benbrahim

- Tallaa et al. (2009) showed that cadmium transformed normal human breast

cells into cells that displayed characteristics of basal

- like breast carcinoma. These cells, when
injected into mice, produced invasive, metastatic cancer.

I n a study of effects of cadmium on kidney cells, Chakraborty et al. (2010) reported that
cadmium exposure caused changes in the cells related to proliferation and survival of
preneoplastic cells, possibly prov i ding a mechanism for cadmium

- induced carcinoge nicity.

Discussion

Cadmium is poorly absorbed in the body following exposure by inhalation (about 25 percent) or
ingestion (about 1

– 10 percent)

. C admium that is absorbed can be found largely in the liver and
kidney . Cadmium is excreted slowly ; estimated half

- lives of cadmium in tissues are 6

– - 38 year s for the human kidney and 4

– 19 years for the human liver.

Cadmium has effects on numerous organ systems and cells within the body, principally the
kidney and bone. Although cadmium exposure through inhalat ion in workers is associated with
lung cancer, there is insufficient evidence in humans or experimental animals to determine

whether cadmium is carcinogenic from oral exposure. CPSC staff concludes that t he data are

sufficient for cadmium to be considered toxic under the FHSA

.
Based on a review of the data, the effects in the kidney can be considered the most sensitive
endpoint. Cadmium exposure is associated with increased excretion of b iomarkers for kidney
dysfunction

, includ ing urinary N

- acetyl

- β

- D

- glucosaminidase (NAG), human complex

- forming
protein ( p HC), β 2 

## - microglobulin (β2M)

, and total protein, and decreased glomerular filtration

rates (GFR).

CPSC staff identified the analysis of Suwazono et al. (2006) as the key study fo r an exposure

response analysis because this analysis was based on a large

, well

- characterized population of
women who had no particular environmental or occupation al exposure to cadmium; the study
population excluded individuals such as those with diabete s, kidney cancer, or those who use d
certain medications; the analysis controlled for other potential confounders ; and the estimated
critical effect level was among the lowest estimated from the many published analyses

.

Suwazono et al. (2006) used a bench mark dose approach to analyze the data from the study of
820 Swedish women. The analysis estimated the concentration of cadmium in urine associated
with urinary protein markers (NAG and pHC) for adverse effects in the kidney. These31 

## researchers reported a benchmark dose (BMD) for a 5 percent excess risk for each of the proteins

excreted in the urine of 0.6 micrograms cadmium per gram creatinine in the urine

(0. 6 μg/g creat.) . The lower confidence limit of the cadmium concentration BMD ( i.e. , BMDL )

was 0.5 μg/g creat. Similar results were reported by Uno et al . (2005) and Järup et al . (2000).

Because the BMDL is a measure of cadmium excreted in urine, additional analysis is required to
estimate the corresponding level of cadmium intake into the body . This can be done using
modeling techniques. The derivation of the MRL presented in the draft ATSDR Toxicological
Profile for Cadmium (ATSDR , 2 008) has applied such an analysis using the results of several
studies of European populations, including Suwazono et al. (2006). For a 0.5 μg/g creat. urinary

concentration, the analysis published by ATSDR (2008) estimated a level of cadmium intake of

0.33 μg/kg/day . This is the intake level chosen by CPSC staff as the critical exposure level.

The scientific community generally addresses uncertainty in the understanding of toxicology and

dose

- response through the use of uncertainty factors. CPSC staff also uses an uncertainty factor
approach in evaluating exposure levels to account for a lack of robust data from anima l studies,
or a lack of information from human exposures (CPSC , 1 992). CPSC staff may apply up to three
uncertainty factors, depending on the completeness and relevance of the available data. An
uncertainty factor may be used if data are available only i n studies of animals and not in humans.
An uncertainty factor is applied if the available studies do not identify a dose or exposure level
that is not associated with an adverse effect ( no observed adverse effect level or NOAEL)

. When a benchmark dose ap proach is used, the BMDL is treated as a NOAEL. The third type of
uncertainty factor is applied to account for sensitive populations if the available studies do not
adequately address such concerns.

In this case, only one uncertainty factor is needed, whi ch is intended to account for the
possibility of sensitive members of the population. S taff has chosen to apply a reduced
uncertainty factor of 3, rather than the factor of 10 that is more typically used because of lack of
knowledge of effects throughout a population. The reduced uncertainty factor is appropriate in

this case because of the strength of the data that supports the identified critical exposure level,
based on multiple studies of large numbers of people in different parts of the world. There fore,
an uncertainly factor of 3 applied to the intake level of 0.33 μg/kg/day results in an acceptable
daily intake (ADI) of 0.1 μg/kg/day. This is the level of chronic exposure that should not be

exceeded in order to avoid health effects.

Conclusion

The data concerning the toxicity of cad mium is sufficient for cadmium to be considered toxic

under the FHSA due to effects on multiple organ systems and toxic endpoints, including kidney
dysfunction. CPSC staff has developed an ADI for chronic exposure to ca dmium by the oral

route of 0. 1 μg/kg/day

, based on studies in human populations. Chronic exposures above the

ADI of 0.1 μg/kg/day could cause adverse health effects.32 

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A 39(9):2507

– 2515.CPSC Hotline: 1

- 800

- 638

- CPSC(2772) CPSC's Web Site: http://www.cpsc.gov 

# Staff Report on Toy Standard Test Methods with Data
from Testing Metal Jewelry and Other Materials

August 2010

### ii 

# Table of Contents

Staff Report

................................ ................................ ................................ ................................ .... iii

TAB A: Summary of Test Results for Lead in Children’s Metal Jewelry

................................ ...... 9

TAB B: Assessment of Cadmium Migration from Materials

................................ ....................... 28

### iii 

# Staff Report

## U NITED 

## S TATES



## C ONSUMER 

## P RODUCT 

## S AFETY 

## C OMMISSION



## 4330 E AST 

## W EST 

## H IGHWAY



## B ETHESDA 

## , M ARYLAND 

## 20814

Memorandum

CPSC Hotline: 1

- 800

- 638

- CPSC(2772) CPSC's Web Site: http://www.cpsc.gov 

## Date: August 10, 2010

TO : Robert J. Howell, Assistant Executive Director, Office of Hazard Identification

and Reduction

THROUGH : Mary Ann Danello, Ph.D., Associate Executive Director, Directorate for Health

Sciences

Lori E. Saltzm an, M.S., Director, Division of Health Sciences, Directorate for

Health Sciences

FROM : Kristina M. Hatlelid, Ph.D., M.P.H., Toxicologist, Directorate for Health

Sciences

SUBJECT : CPSC Staff Discussion of Toy Standard Test Methods 1



## Background

U.S. C onsumer Product Safety Commission (CPSC) staff, as part of its work on possible hazards

of children’s jewelry and other products has considered the toy safety standards with respect to
the requirements and test methods for certain chemical elements, such a s cadmium. This
discussion and the accompanying staff technical reports consider methods that CPSC staff has
used to test and evaluate certain children’s products, describe the current toy safety standards,
and provide the staff’s preliminary conclusion a bout testing methods for certain types of
products.

Toxicological evaluation

Assessment of children’s products for regulation under the Federal Hazardous Substances Act
(FHSA) involves identification of possible hazards, including toxicity. Staff evaluate s chemicals
through toxicological review and quantitative dose

- response analysis. With sufficient data on
the chemical of interest, staff may estimate the level of exposure that if exceeded would be
associated with adverse health effects, generally termed the acceptable daily intake level (ADI).

Exposure to elements from consumer products

To assess whether use of a product could result in excess exposure to a child, staff estimates
possible chemical exposure through testing of products.

1 These comments are tho se of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views

of, the Commission.

### 2 

## Children may be ex posed to chemicals in products from direct mouthing of objects, from
handling such objects and subsequent hand

- to

- mouth activity, or from ingesting a small item or a
portion of a product.

CPSC’s Directorate for Laboratory Sciences (LS), Division of Chemist ry (LSC) staff evaluates
possible exposures to chemicals from children’s products that may be mouthed or swallowed by
measuring leaching of the chemical from the item using a saline solution to mimic the effects of
mouthing, and a mild acid solution to sim ulate the effects of swallowing an item . In some cases in which exposure might occur from handling a product and subsequent hand

- to

- mouth activity,
staff may use a procedure that simulates hand contact with a product through repeated swiping of

the surface with a moistened wipe . Both the saline and acid leaching methods involve placing
the item in the solution for specified time periods of at least six hours. For mouthing, the staff
assumes that each minute of extraction in the saline solution represents a minute of mouthing of
the object by a child. For the ingestion scenario, staff assumes that the leaching time represents
the time the item is exposed to the acidic environment of the stomach.

S taff has use d an acid extraction test carried out over six h ours to reflect the length of time it
takes for food to move through the stomach and small intestine, where the absorption of
chemicals generally takes place. However, in the course of testing and evaluation of children’s
metal jewelry containing lead ove r the past several years , staff learned that the se test conditions
may not necessarily mimic the circumstances of ingestion of products.

As part of a previous staff project on lead in children’s metal jewelry, the staff examined data

from three cases in wh ich ingestion of a lead

- containing jewelry item was associated with
prolonged exposure to an item. A four

- year

- old Oregon boy had a blood lead level (BLL) 2 

## of

123 μg/dL approximately three to four weeks after swallowing a pendant containing 38.8 percent

l ead (VanArsdale et al. 2004). The pendant was surgically removed from the child. A 4

- year

old Minnesota boy died with a BLL of 180 μg/dL after ingesting a bracelet charm 3



## Numerous ot her reports in published literature and CPSC databases demonstrate that children
ranging in age from 9 months to 17 years have had exposure to lead from ingesting products
such as jewelry, game pieces, crayons, chalk, lead weights/sinkers/pellets, lead sho t/bullets, and
curtain weights (Durback 1989, Fergusson 1997, Greensher 1974, Hugelmeyer 1988, Mowad
1998, Sprinkle 1995; CPSC databases). , determined
by the state public health department laboratory as containing 99.1 per cent lead (CDC 2006). A

nine

- year

- old boy’s BLL rose to 27 μg/dL four days after he swallowed a ring containing 90
percent lead. Three days later his BLL rose to 54 μg/dL, at which time endoscopy was
performed to remove the ring (CPSC files).

As demonstrated by these cases, ingested foreign bodies may not be eliminated quickly from the
body, but can be ret ained within the digestive tract for an extended period of time. This has been
shown in a 1998 study of 100 children aged 9 months to 13 years who ingested various foreign
bodies (objects included coins, ball bearings, pins, marbles, screws, buttons, a li ght bulb, a
novelty nail file and a clothespin) (Macgregor and Ferguson 1998). The total transit time for

2 BLL is a measure of recent exposure to lead. From a recent national survey, the geometric mean BLL in children aged

1

- 5 years was 1.9 μg/dL (CDC 2005). There is no known threshold for adverse effects of lead; CPSC staff has evaluated product
exposures using 10 μg/dL as the level that should not be exceeded in order to avoid serious adverse health effects.

3 The length of exposure in this case is unknown, but several days passed between initial presentation of illness and the discovery
of the object in the gastrointestinal tract.

### 3 

## passage (from ingestion to elimination through the rectum) of these items ranged from 1 to 46
days. The peak time of passage was two days with a med ian time of six days. The authors noted
that the mean transit time for an ingested object increased with age; it was greater than 15 days

for 13

- year

- olds while it was typically five days for 4 through 10

- year

- olds.

Ingestion of items such as jewelry is n ot an infrequent occurrence for children of all ages. As
presented in Tab D of the Briefing Package for Petition Requesting Ban of Lead in Toy Jewelry
(Petition No. HP 06

- 1) 4



## Data: Lead in Jewelry , CPSC’s Directorate for Epidemiology, Division of Hazard Analysis
staff analyzed data from the National Electronic Injury Surveillance System (NEISS) database on

emergency room

- treated injuries associated with ingestion of consumer products by children.
The staff searched the data for cases involving ingestion of foreign objects by c hildren aged 18
years and younger and, because NEISS is a probability sample, established national estimates for
ingestions by age group and product type. For 2000

- 2005, the staff estimated 302,587

emergency room

- treated injuries, nearly 80 percent of whi ch were children under seven years of

age . The remaining 20 percent of the estimated injuries were reported in youths aged seven to 18
years. The objects most commonly swallowed were coins, accounting for nearly half of
ingestions, followed by jewelry

, t oys not elsewhere classified

, and nails, screws, tacks or bolts.
Other major product categories included batteries

, marbles

, and non

- electric Christmas
decorations. Just considering cases involving jewelry, the staff estimated nearly 20,000 total

emergen cy room

- treated ingestions, about 62 percent of which were in children under age seven
years, with the remaining 38 percent in children aged seven to 18 years.

In 2004, CPSC staff increased efforts to protect children from lead in pro ducts. In particular, the
staff focused on hazardous lead exposures from swallowing lead

- containing metal jewelry. To
avoid exceeding the 10 μg/dL blood lead level (BLL) of concern from acute exposure, the staff
recommended that children not ingest more than 175 μg of accessible lead in a short period, such

as might occur if a piece of jewelry were ingested

. Therefore, children’s metal jewelry samples

that resulted in extraction of more than 175 μg of lead would be considered to be potentially

associated with excess lead exposure if ingested by a child.

Staff analyzed hundreds of jewelry items such as beads, pendants

, and other components of
jewelry using the mild acid extraction test. The acid extraction test to simulate the effect of

stomach acid on an ingested item was typically carried out for six hours to reflect the length of
time it takes for food to move through the stomach and small intestine. Results of testing
children’s metal jewelry for lead content and lead solubility after six hours of ext raction were presented in the staff briefing package for the petition on lead in toy jewelry (Tab B of the
petition package ).

Since CPSC staff was interested in the accessibility of lead from ingested items that might
remain in the gastrointestinal tract f or longer periods of time, an additional extraction period of
18 hours (for a total extraction time of 24 hours) was added to the extraction protocol. The
staff’s test p rotocol for each sample involved a one

- hour extraction, followed by a two

- hour

extract ion with fresh extractio n solution, followed by a three

- hour extraction with fresh solution,

for a total of six hours. The latter time point was followed by an addition of fresh extraction

4 Available at http://www.cpsc.gov/library/foia/foia07/brief/LeadToyJewelry.pdf

.

### 4 

## solution for the remaining 18 hours of extraction. Results of test ing using this revised protocol
for samples collected in and tested in fiscal year 2007 are presented in Tab A

.

Both the 2004 and 2007 data sets described above show ed that

, for most samples, the amount of
lead that migrated from the item generally depende d on the amount of lead present in the sample,
with larger levels of extraction from samples with higher total lead content, although there is no
strict relationship between content and solubility.

The 2007 report shows that migration of lead generally inc reases with increasing time in the acid
extraction solution. However, in many cases, there is little change in the amount of lead
migration over the first several time points. The staff also observed for many samples that low

levels of lead extraction at the early time points were followed by large increases in lead release

either at the six

- hour point or the 24

- hour point.

This report included acid extraction results for 378 metal jewelry items. For the 197 items that
had more than 0.06 percent total le ad that were tested for accessible lead, 110 (56%) had
accessible lead greater than 175 μg after 6 hours, and 125 (63%) had accessible lead greater than
175 μg after 24 hours. Of the 218 metal items that had less than ten percent total lead, six had

acces sible lead greater than 175 μg after six hours, and ten had greater than 175 μg after 24

hours.

Thus, i ncreasing the extraction time for metal items from six hours to 24 hours showed an

increa se in the proportion of product samples with accessible lead mor e than 175 μg , as well as

levels of accessible lead that were much higher at the later time point. The average amount of
accessible lead after 24 hours (8,200 μg) was about five times larger than the average after six
hours (1,600 μg).

While the focus of the staff’s jewelry analyses was on metal items, a number of non

- metal
samples were tested for lead accessibility. Of 71 non

- metal items tested , 31 were c rystal. Some
of the crystal items had total lead content up to 25 percent , but none had extractable lead greater

than 175 μg after testing for up to 48 hours . Plastic items accounted for most of the remainder of
the items tested. Only polyvinyl chlori d e (PVC) types of plastics had significant lead content

. As with the metal items, lead migration tende d to increase with increasing length of extraction

time. Of nine PVC plastic items , containing lead up to 0.8 percent, two had extractable lead
results greater than 175 μg after 2 4 hours of testing, and an additional two samples exceeded 175
μg after 4 8 h ours . All four of these samples were relatively large necklace cords or choke collar

necklaces

. Data: Cadmium in Jewelry

Recently, staff has evaluated the potential for hazardous exposures to cadmium that might occur
from mouthing or swallowing cadmium

- co ntaining children’s metal jewelry (Tab B). At this

time, the amount of data on cadmium

- containing children’s metal jewelry is limited compared to

that for lead

- containing children’s metal jewelry. Also, the staff has not identified a specific

total cadmi um content level that might indicate a possible hazard, or a level of cadmium
exposure that children should not exceed that would be used to identify products with the
potential to cause excess exposure to cadmium or to define a cadmium extraction limit fo r certain products.

Staff evaluated 20 cadmium

- containing jewelry items ( i.e. , finished products of various sizes and
designs, generally including electroplating or other surface finishes), several non

- product metal

### 5 

## alloy samples in wire or powder form, an d several non

- product plastic samples. The extraction

test methods used were the same methods used to evaluate lead content and lead extraction from
children’s metal jewelry.

The limited data on extraction of cadmium from jewelry items show that, like lea d, there is no
strict relationship between cadmium content and cadmium solubility. However, for many
samples, those with higher total cadmium content generally had higher levels of extraction. The

staff did not collect as much data for cadmium

- containing jewelry as is available for the lead

containing samples. Thus, the staff does not have data on the extraction of cadmium over time
from electroplated jewelry samples.

Data from testing cadmium

- containing alloys that were not electroplated or coated sho w proportionally increasing extraction of cadmium over time. The staff would hypothesize that the
presence of electroplating would have resulted in initially low levels of extraction, followed by
increasingly higher amounts of extraction, but this cannot be shown at this time.

As with the testing of plastic for lead migration, cadmium extraction from plastics was
considerably less than extraction from metals. Again, an extraction limit for cadmium from
children’s products has not been defined. Therefore, the staff cannot conclude whether cadmium
leaching from plastic items would be excessive or not.

Toy Standards: ASTM F963, EN71

- 3

The ASTM International Standard Consumer Safety Specification for Toy Safety (ASTM F963)
covers migratable ( i.e., soluble, le achable) elements from paints and coatings on toys, with a
specific test method.

The current European Standard Safety of Toys

- Part 3: Migration of certain elements (EN 71

- 3 :1994 ) covers any toy material, clay, and finger paint, in addition to paints and co atings, with
specified test methods. Thus, the materials included in the scope of EN 71

- 3 exceed the scope of

ASTM F963. However, EN 71

- 3 does not apply to all toys. This standard is for toys that are
likely to be sucked, licked

, or swallowed, especiall y toys for children up to age six years , as well

as cosmetic toys, writing instrument toys , and toys for food contact. Jewelry is not included in
the scope of either the ASTM or EN standard, except for toy jewelry . Children’s jewelry is
generally not toy jewelry. Staff is not aware of a European standard for jewelry, except for the

nickel directive 5



## Except for the differences in scope, the two standards have similarities . Both standards include
requirements for migratable chemicals, not total chemical content. The test methods in both
indicate that certain types of materials are to be ground or homogenized, such as paints and
coatings. In EN 71

- 3 , some materials are extracted whole, such as glass/ceramic/metallic
materials, if the toy or component fits entirely within the small parts cylinder. Both standards

indicate the amount of material to be tested, how the test material is to be prepared, the amount

of acid to be used for the test , and other details for different materials ; but generally, the test
methods are similar, and the migration limits are the same. , which restricts the amount of nickel that may contact skin due to the potential

for health effects from sensitization

.

5 Directive 2004/96/EC o f the European Parliament and of the Council of 27 September 2004 amending Council Directive
76/769/EEC as regards restrictions on the marketing and use of nickel for piercing post assemblies for the purpose of adaptin g its
Annex I to technical progress.

### 6 

## A key aspect of the methods in both standards that differs significantly fr om the CPSC staff
approach to evaluating certain products for the presence of a chemical hazard is that the
extraction period in the toy standards is two hours. In contrast, CPSC staff typically uses an
extraction period of at least six hours.

The basis of EN 71

- 3 is that a child is assumed to have an average daily intake (ingestion) of toy

material of 8 milligrams (mg) per day. The standard acknowledges that in certain individual
cases this figure might be exceeded. CPSC staff believes that the 8 mg/d ay assumption might be
reasonable for paints and coatings, or materials that can be scraped off or that break up into small
bits. As the language of the standard acknowledges, this level of ingestion could be exceeded in

some cases.

To understand the impl ications of conditions of a test, consider the case of ingestion of small
amounts of a toy material, such as paint or other scrapings or small bits. In this case, a two

- hour
extraction period may reasonably indicate whether excess leaching might occur. F or such small
bits, we might expect that ingestion would be followed by a relatively normal rate of elimination
from the body as the small scrapings or pieces become mixed up in food and are transported
through the gastrointestinal tract. Even if such sma ll bits were not eliminated from the body
within a day or two, as is the typical transit time for food, the exposure to chemicals that might
migrate from the ingested materials is limited by the small size of the particles.

On the other hand, items such as the glass/ceramic/metallic components that fit within the small
parts cylinder and are tested intact, or any other item that is ingested as a piece rather than as a
scraping or small bit, generally are considerably larger than 8 mg, with mass perhaps up t o about
5 grams . These large items might remain in the stomach or GI tract for longer periods of time.

As we learned from the jewelry ingestion cases, and from a report in the literature o n ingested
foreign bodies (Mcgregor and Ferguson 1998), an objec t may remain in the body for days or
weeks. For these larger objects, a two

- hour test may not be adequate to determine whether
excessive leaching might occur. On the other hand, for certain materials such as glass, a longer
extraction time may not result in significantly more leaching than a shorter time. This is because
some materials are not susceptible to dissolving under the test conditions of the standards, and
only chemicals at the immediate surface of the product are available for leaching.

Anot her reason that the shorter test might not be appropriate for some products is that plating or
coating , if present on the product or component , could initially block the migration of the
elements. Again, from the staff’s jewelry investigations, we know th at such coatings will
eventually weaken and allow the acid to reach the underlying material. In these cases, leaching
would be evident only after several hours in the acid solution.

New EU standard

There is a new EU toy safety directive 6

6 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys. 

## that will result in significant changes in the EN 71

- 3
migration of elements standard. The new requirements for chemicals in toys are to go into effect

in 2013. The exact form of the new standard is not known, since some of the details for
implementing the new directive need to be worked out. However, the new standard will include
a ban of certain fragrance chemicals and restrictions on chemicals that are carcinogenic,
mutagenic, or reproductive toxicants; it adds more elements to the migration standard, sets

### 7 

## different migration limits for the elements that are in the current standard, and sets different
migration limits for different types of materials. The staff has not yet evaluated the
appropriateness of including the additional chemicals, or the revised migration l imits, and cannot
address methods that are not yet available. It is not clear to staff at this point if the scope of
products or materials covered by the standard will change, or whether the test methods will be
significantly revised. The staff does not know when the revised standard will be available.

Conclusion

Considering the available data on small swallowable metal jewelry items and the information
about children’s ingestion of small objects, including cases of serious adverse effects and death

from the chemical content of some of the items, the staff has concerns about the appropriateness

of the two

- hour solubility test in both the ASTM F963 and EN 71

- 3 toy safety standards.
Because an ingested foreign body may remain in the gastrointestinal tract f or extended periods of
time, and some materials are susceptible to excessive leaching of chemicals in the acid

conditions of the stomach, the two

- hour test may not identify products that could lead to excess

exposure. As demonstrated with the results of t he staff’s testing of lead

- or cadmium

- containing
jewelry and metal alloys, increasing the length of time in an acidic solution generally results in
increasing solubility of the chemicals from products. Therefore, for small, swallowable items,
especially metal items, the staff preliminarily recommends that the test procedure be carried out

for 24 hours.

### 8 

## References

CDC (Centers for Disease Control and Prevention) (2005) Blood Lead Levels

– United States,

1999

- 2002. MMWR 54(20): 513

- 516.

CDC (Centers for D isease Control and Prevention) (2006) Death of a child after ingestion of a

metallic charm

– Minnesota, 2006. MMWR 55(Dispatch): 1

- 2.

Durback LF, Wedin GP, Seidler DE (1989) Management of lead foreign body ingestion. J
Toxicol Clin Toxicol 27(3): 173

- 8 2.

Fergusson J, Malecky G, Simpson E (1997) Lead foreign body ingestion in children. J Paediatr

Child Health 33: 542

- 544.

Greensher J, Mofenson HC, Balakrishnan C, Aleem A (1974) Lead poisoning from ingestion of
lead shot. Pediatrics 54(5): 641

- 643.

Hugelmeyer CD, Moorhead JC, Horenblas L, Bayer MJ (1988) Fatal lead encephalopathy
following foreign body ingestion: case report. J Emerg Med 6(5): 397

- 400.

Macgregor D, Ferguson J (1998) Foreign body ingestion in children: an audit of transit time. J Accid Emerg Med 15: 371

- 373.

Mowad E, Haddad I, Gemmel DJ (1998) Management of lead poisoning from ingested fishing
sinkers. Arch Pediatr Adolesc Med 152(5): 485

- 488.

Sprinkle JD, Hingsbergen EA (1995) Retained foreign body: associations with elevat ed lead
levels, pica, and duodenal anomaly. Pediatr Radiol 25(7): 528

- 529.

VanArsdale JL, Leiker RD, Kohn M, Merritt TA, Horowitz BZ (2004) Lead poisoning from a
toy necklace. Pediatrics 114(4): 1096

- 1099.

### 9 

# TAB A : Summary of Test Results for Lead in Children’s
Metal Jewelry 

# T

A

B

A

## U NITED 

## S TATES



## C ONSUMER 

## P RODUCT 

## S AFETY 

## C OMMISSION



## 4330 E AST 

## W EST 

## H IGHWAY



## B ETHESDA 

## , M ARYLAND 

## 20814

Memorandum

CPSC Hotline: 1

- 800

- 638

- CPSC(2772) CPSC's Web Site: http://www.cpsc.gov 

## Date: Aug 1, 2007

TO : Kristina M. Hatlelid, Ph.D., M.P.H., Toxicologist, Directorate for Health

Sciences

THROUGH : Andrew G. Stadnik, P.E., Associate Executive Director, Directorate for
Laboratory Sciences

Joel R. Recht, Ph.D., Director, Division of Chemistry, Directorate for
Laboratory Sciences

FROM : David Cobb, Chemist, Division of Chemistry, Directorate for Laboratory

Sciences

SUBJECT : Summary of Test Results for Lead in Children’s Metal Jewelry 1

, 2



## Summary:

This memorandum provides a summary of the test results of U.S

. Consumer Product
Safety Commission (CPSC) staff te sting for lead (Pb) in children’s metal jewelry in fiscal year
2007. The CPSC Directorate for Laboratory Sciences (LS), Division of Chemistry (LSC) staff
has analyzed 384 children’s metal jewelry items from 10 4 official compliance samples and 73

non

- metal items such as plastic and crystal from 27 official compliance samples. There were

198 metal items tested that had total lead of 0.06% or more. In general, the staff notes that by
visual inspection or XRF ( data not shown ) , the metal items and components w ere finished with

non

- lead metallic coatings or platings, e.g. , copper, nickel. While the integrity of such coatings
was not specifically evaluated, the data show that coatings do not necessarily prevent
accessibility of lead from the item

.

Background:

Under the Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261(f)(1), children’s
metal jewelry items that expose children to hazardous quantities of lead under reasonably
foreseeable conditions of handling or use are banned hazardous substances. In 2 005, CPSC’s
Office of Compliance issued an Interim Enforcement Policy for Children’s Metal Jewelry

1 These comments are those of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views

of, the Commission.

2 N ote this document was initially prepared in 2007 as part of a briefing package considering a ban on lead in children’s metal
jewelry, and does not reflect changes due to the enactment of the Consumer Product Safety Improvement Act of 2008 (CPSIA)

and other later changes. Current testing methods and summaries of regulations for lead in children’s products according to the
CPSIA can be found at http://www.cpsc.gov/about/cpsia/sect101.html

### 11 

## Containing Lead for manufacturers, importers, and retailers. 3 

## The policy was accompanied by a
two part testing procedure. 4



## Test Method: The procedure calls for the dete rmination of the total lead content of
a metal jewelry item by a specified method. Distinct metal component items within a jewelry
sample, such as pendants, hooks, or beads are tested separately for total and accessible lead. If

the total lead in a metal jewelry item is more than 0.06%, then an acid extraction for 6 hours is
conducted by a second specified method. Metal jewelry with more than 175 μg of accessible
lead by this method is subject to further review for age grading, and other risk factors and a risk
assessment may result in enforcement action. Non

- metal jewelry is not addressed in the Interim
Enforcement Policy, but is subject to the FHSA.

Total Lead in Metal

The current test method 4 

## for total lead is based on methodology found in Canada Product

Bureau Method C

- 02.4, and has been used for samples analyzed since December 2004. This
method requires that the aliquots be ground into small particles to increase the rate of dissolution,

a nd the procedure also contains a step for adding hydrochloric acid to assist in dissolving certain
metal alloys.

Total Lead in Plastic

Plastic items were ashed in a muffle furnace at 600°C. 10

- 50 mg aliquots of the ashen

item were dissolved in 2

- 3 ml of nitric acid on a hot plate. The digests were analyzed using
inductively coupled plasma atomic emission spectroscopy (ICP) to determine lead content.

Total Lead in Crystal

Aliquots of crystal items were microwave digested with 2 ml of nitric acid and 1 m l of
hydrofluoric acid. The digests were diluted with 4% boric acid to neutralize any free fluoride
and analyzed by ICP to determine lead content.

Accessible Lead

The acid extraction test method 4 

## for accessi ble lead calls for an acid extraction that
simulates exposure to metal that is ingested into the alimentary tract. The acid extraction
involves placing an intact jewelry item in 0.07N hydrochloric acid (HCl) at 37°C for 6 hours.
This procedure is based o n methodology found in ASTM C927, C738, D5517, and F963.
Extended acid extractions to 24 hours were performed on metal items. Plastic and crystal items
were extracted with 0.07N HCl at 37°C for up to 48 hours.

3 Interim Enforcement Policy for Children’s Metal Jewelry Containing Lead

- 2/3/2005.

4 CPSC Standard Operating Procedure for Determining Lead (Pb) and Its Availability in Children’s Metal Jewelry 2/3/05,
http://www.cpsc.gov/businfo/pbjeweltest.pdf.

### 12 

## RESULTS AND DISCUSSION:

The test results for the samples are contained in Tables 1 and 2. The results showed that
197 out of 381 metal items tested (52%) had total lead of 0.06% or more. Acid extractions were

done on 378 metal items; for the 197 items that had more than 0.06% total lead that w ere tested
for accessible lead, 110 (56%) of those items had accessible lead greater than 175μg after 6
hours, and 125 (63%) had accessible lead greater than 175μg after 24 hours. Of the 218 metal

items that had less than 10% total lead, 6 of those had ac cessible lead greater than 175μg after 6
hours, 10 had greater than 175μg after 24 hours. One item that had less than 0.06% total lead
had accessible lead greater than 175μg after 24 hours.

Increasing the extraction time for metal items from 6 hours to 2 4 hours showed an increase
in the proportion of products with accessible lead greater than 175 μg. The results also show ed

that the levels of accessible lead were much higher after 24 hours compared to 6 hours. The
average 24 hour accessible lead (8183μg ) was about 5 times as large as the average 6 hour
accessible lead (1564μg).

There were 71 non metal items tested. Crystal accounted for 31 of those items. Some of
the crystal items had total lead up to 25%, but none of the crystal items had extractabl e lead
greater than 175μg. Plastic items accounted for most of the remainder of the items tested. Only
polyvinyl chlorine (PVC) types of plastics had significant total lead. There were 9 PVC plastic
items tested with lead levels up to 0.8%. Four of the se items , with extractable lead results
greater than 175μg after 48 hours of testing, were relatively large necklace cords or collars,
weighing several grams.

### 13 

## Table 1. Metal Jewelry Results

Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3 =

6 1+2+3+

18=24

1.0 2.0 3.0 18

06

- 810

- 3976 3 necklace chain 0.015

06

- 810

- 3976 3 necklace teardrop pendant 96.2

06

- 810

- 3976 3 necklace hook 98.7

06

- 810

- 3976 3 necklace heart pendant 97.8

06

- 810

- 3976 4 necklace chain 0.38 2.5 0.4 0.0 0.9 2.9 3.8

06

- 810

- 3976 4 necklace teardrop pendant 0.38(2) 494 684 659 8265 183 8 1010 3

06

- 810

- 39 76 4 necklace hook 0.68 1207 1030 1203 7276 3440 1071 7

06

- 810

- 3976 4 necklace heart pendant 5.04 5.0 12.6 47.9 3150 65.5 321 6

06

- 810

- 3976 5 necklace chain 0.38 2.3 0.8 0.6 1.1 3.7 4.8

06

- 810

- 3976 5 necklace teardrop pendant 0.42(2) 466 735 1014 7476 2215 9691

06

- 810

- 3976 5 necklace hook 0.66 544 1052 1065 1019 2663 368 3

06

- 810

- 3976 5 necklace heart pendant 5.18 12.9 5.2 20.7 134 7 38.8 138 6

06

- 810

- 3976 6 necklace chain 0.002

06

- 810

- 3976 6 necklace teardrop

pen dant 99.2

06

- 810

- 3976 6 necklace hook 87.3

06

- 810

- 3976 6 necklace heart pendant 93.5

06

- 840

- 7517 1 anklet charm 3.3 87.6 892 168 5 314 3 23362 57 20 29082

06

- 840

- 7517 2 anklet charm 3.1 80.9 405 76 6 1279 1765 8 2450 2010 8

06

- 840

- 7642 3 bracelet charm 2.69 0.44 7.7 0.5 0.4 9.0 8.6 17.6

06

- 840

- 7642 4 bracelet charm 2.57 0.43 5.8 2.3 4.6 5.1 12.8 17.9

07

- 810

- 4655 3 Necklace Charm back 6.615 95.3 31.8 65.9 98.3 7259 196 7455

07

- 810

- 4655 6 Necklace Charm b ack 5.867 92.1 750 120 2 316 8 3637 2 5120 4149 2

07

- 302

- 0045 1 necklace pendant 5.55 25.1 6936 1423 8 22312 104706 43486 148192

07

- 302

- 0046 1 necklace cross pendant 4.64 44.2 559 988 1791 15776 3338 19114

07

- 302

- 0046 1 necklace cross pendant clasp 3.5

07

- 302

- 0046 1 necklace star pendant 4.18 44.4 62.7 1 30 234 1521 426 194 8

07

- 302

- 0046 1 necklace star pendant clasp 42.5

07

- 302

- 0075
1 key chain pendant 20.32 0.023 0.0 0.0 0.0 0.0

07

- 302

- 0075
2 key chain pendant 20.38 0.068 17.4 0.0 0.0 0.0

07

- 302

- 0075 3 key chain pendant 20.10 0.025 43.0 0.0 0.0 0.0

07

- 302

- 0075 4 key chain pendant 20.89 4.27 22 6 284 356 1569 86 6 2435

07

- 302

- 0075 5 key chain pendant 21.88 0.121 11 8 0.0 0.0 11 8

07

- 302

- 0075 6 key c hain pendant 20.81 0.131 0.0 0.0 0.0 0.0

07

- 302

- 0075 4 key chain chain 3.50 0.235 2.0 0.0 0.0 1199 2.0 1201

07

- 302

- 0075 5 key chain chain 3.47 0.009 2.7 2.0 0.0 407 4.7 41 2

### 14 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3

= 6 1+2+3+18

=24

1.0 2.0 3.0 18

07

- 302

- 0075 4 key chain key ring 3.92 10.8 2.6 0.0 23 6 13.4 249

07

- 302

- 0075 5 key chain key ring 3.92 3.1 0.0 0.0 46.5 3 .1 49.6

07

- 302

- 0075 6 key chain key ring 0.008

07

- 302

- 0075 6 key chain key ring 0.002

07

- 302

- 0093 1 Token Token 16.208 0.0 0.0 8.3 11865 8.3 11874

07

- 302

- 0093 6 Token Token 14.808 0.0 0.0 0.0 12.1 0.0 12.1

07

- 302

- 3734 1 Ring 0.576 76.9 25 3 418 75 8 2678 142 9 4107

07

- 302

- 3734 2 Ring 0.622 55.5 58 7 1189 152 3 7239 329 9 1053 8

07

- 810

- 1371 1 necklace hook 4.46 0.229 16.8 2.8 0.4 2.6 20.0 22.6

07

- 810

- 1371 1 necklace Clasp 1.16 84.4 2820 190 6 283 4 18 854 75 60 26414

07

- 810

- 1371 1 necklace pendant 0.011

07

- 810

- 1371 2 necklace hook 4.71 0.026 2.7 0.5 0.5 0.3 3.7 4.0

07

- 810

- 1371 2 necklace Clasp 1.33 95.7 91 8 1471 2021 11990 4410 1640 1

07

- 810

- 1371 2 necklace pendant 0.01

07

- 810

- 1372 1 Rin g 8.82 0.003 3.8 2.1 0.0 1.5 5.9 7.4

07

- 810

- 1372 2 Ring 5.6 0.001 1.8 1.5 0.5 0.0 3.8 3.8

07

- 810

- 4100 1 bracelet 4.02 0.01 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4100 2 bracelet 4.7 0.043 0.0 0.0 4.7 9.4 4.7 14.1

07

- 810

- 4126 1 key chain charm 22.6 100 1021 2863 5396 92950 9280 102230

07

- 810

- 4126 2 key chain charm 22 96.4 921 2245 3390 67779 6556 74335

07

- 810

- 4127 1 Ring 9.16 77.9 25 7 540 5083 87 5 595 9

07

- 810

- 4127 2 Ring 88.5

07

- 810

- 4127 4 Ring 90.5

07

- 8 10

- 4127 5 ring 11.97 18 6 496 79 7 7727 147 4 920 1

07

- 810

- 4172 1 necklace hook 0.4739 0.062 0.8 0.7 0.0 1.5 1.6 3.1

07

- 810

- 4172 1 necklace pendant

- lock 0.4279 0.008 0.2 0.0 0.0 0.0 0.2 0.3

07

- 810

- 4172 1 necklace pendant

- heart 0.7316 0.075 19.1 0.0 0.0 1.3 19.1 20.4

07

- 810

- 4172 2 necklace hook 0.4222 0.107 9.1 1.3 0.7 2.1 11.1 13.2

07

- 810

- 4172 2 necklace pendant

- lock 0.4496 0.007 31.0 1.9 0.2 0.9 33.1 34.0

07

- 810

- 4172 2 necklace pendant

- heart 0.6730 0.038 0.2 0.0 0.0 0.0 0.2 0.2

07

- 810

- 4173 1 neckla ce hook 0.4 0.062 15.9 31.6 0.7 0.6 48.2 48.8

07

- 810

- 4173 1 necklace Pendant 1.815 0.004 8.0 0.2 0.0 0.0 8.1 8.1

07

- 810

- 4173 1 necklace Pearl earring

setting 0.124 0.001 0.9 13.8 5.7 0.4 20.5 20.9

07

- 810

- 4173 2 necklace hook 0.4631 0.072 20.5 1.4 0.9 1.1 22.9 23.9

07

- 810

- 4173 2 necklace Pendant

- metal 1.475 0.022 55.8 12.1 12.1 1.8 80.0 81.8

07

- 810

- 4173 2 necklace “diamond” earring

- setting 0.4082 0.032 15.9 0.2 0.0 0.1 16.1 16.2

07

- 810

- 4173 2 necklace Pearl earring

setting 0.1762 0.015 39.2 22.8 1 0 .6 4.0 72.7 76.7

### 15 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3

= 6 1+2+3+18

=24

1 2 3 18

07

- 810

- 4294 1 Ring dark b lue stone 1.76 65.1 110 176 1548 351 1899

07

- 810

- 4294 2 Ring dark blue stone 92.5

07

- 810

- 4294 3 Ring blue stone 2.09 81.2 18.9 108 28 8 4084 41 5 4499

07

- 810

- 4294 3 Ring no stone 1.6 71.9 53.6 103 16 9 952 32 6 127 8

07

- 810

- 4294 4 Rin g no stone 0.68 0.031 1.4 1.0 2.0 23.1 4.4 27.5

07

- 810

- 4294 5 Ring green stone 1.19 68.9 6.0 0.0 3.6 49.2 9.6 58.8

07

- 810

- 4294 5 Ring pink stone 1.79 80.5 0.0 0.0 9.0 38 8 9.0 39 7

07

- 810

- 4294 5 Ring blue stone 1.92 73.7 82.6 280 720 5260 108 3 634 4

07

- 810

- 4294 6 Ring no stone/thin

ban 1.8 75.9 3.6 24.3 70.2 1863 98.1 1961

07

- 810

- 4470 1 necklace pendant 13.36 0.004 0.0 0.0 0.0 7.3 0.0 7.3

07

- 810

- 4470 1 necklace hook 0.49 0.009 0.7 0.0 0.0 1.2 0.7 1.9

07

- 810

- 4470 1 necklace tear drop

charm 0.17 4.15 0 .1 0.1 0.1 86.4 0.3 86.7

07

- 810

- 4470 3 necklace pendant 13.39 0.004 0.0 0.0 14.4 6.1 14.4 20.5

07

- 810

- 4470 3 necklace hook 0.49 0.011 0.3 0.5 1.5 2.0 2.3 4.3

07

- 810

- 4470 3 necklace tear drop

charm 0.17 3.71 0.0 0.2 0.0 3.4 0.2 3.6

07

- 810

- 4471 1 zipper pull 0.02 4.37 9.4 2.0 0.0 0.0 11.4 11.4

07

- 810

- 4471 1 zipper hook 0.007 0.71 15.9 25.7 30.3 23.1 71.9 95.0

07

- 810

- 4471 4 zipper pull 0.023 4.35 7.7 2.8 2.1 2.4 12.6 15.0

07

- 810

- 4471 4 zipper hook 0.012 0.65 0.0 0.0 0.0 4.5 0.0 4.5

07

- 810

- 4471 5 zipper pull 0.153 4.37 4.0 0.0 0.0 3.0 4.0 7.0

07

- 810

- 4471 5 zipper hook 0.012 0.72 13.7 22.5 32.2 51.0 68.4 119

07

- 810

- 4502 3 necklace charm 9.529 0.037 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4502 3 hook 0.477 0.022 0.2 0.0 0.0 0.0 0.2 0.2

07

- 810

- 4502 6 charm 9.626 0.01 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4502 6 hook 0.023 0.0 0.0 0.0 2.2 0.0 2.2

07

- 810

- 4502 3 and

6 tear drops 0.304 4.48 1.8 0.1 0.6 34 4 2.5 346

07

- 810

- 4519 1 bracelet pendant 11.37 1829 2891 6248 77362 10968 88330

07

- 810

- 4519 1 bracelet hook 1.11 957 2244 3481 22600 6682 29282

07

- 810

- 4519 2 bracelet pendant 10.38 29 6 270 441 8874 100 7 988 2

07

- 810

- 4519 2 bracelet hook 1.08 64 3 2214 435 8 32098 7214 39312

07

- 810

- 4519 3 bracelet pendant 10.98 102 115 225 1290 163 1

07

- 810

- 4519 3 bracelet hook 83.6

07

- 810

- 4519 4 bracelet pendant 11.2 90.6 5.6 28.0 89.6 123

07

- 810

- 4519 5 bracelet pendant 97.4 47 5 520 68 1 7 1676

07

- 810

- 4519 5 bracelet hook 11.43 92.4

07

- 810

- 4519 6 bracelet pendant 10.77 91.3 0.0 21.6 64.7 86.3

07

- 810

- 4599 4 Ring 1.9 0.01 0.0 0.0 0.0 3.8 0.0 0.0

07

- 810

- 4599 5 Ring 0.31 0.001 1.1 0.0 0.0 0.0 1.1 0.0

### 16 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3 =

6 1+2+3+

18=24

1 2 3 18

07

- 810

- 4600 1 Ring 1.799 0.063

07

- 810

- 4600 3 Ring 1.557 0.076

07

- 810

- 4601 3 Bracelet 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4601 6 Bracelet 0. 0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4654 1 ring 13.48 3321 4252 5042 28552 12622 41175

07

- 810

- 4654 2 ring 80.2

07

- 810

- 4654 5 ring 12.71 179 4 2620 2932 13546 7339 20886

07

- 810

- 4654 6 ring 85.5

07

- 810

- 4655 3 nec klace charm 6.615 95.3 31.8 65.9 98.3 7259 196 7455

07

- 810

- 4655 6 necklace charm 5.867 92.1 750 120 2 5120 34419 7072 41491

07

- 810

- 4656 1 necklace Clasp 0.4136 65.6

07

- 810

- 4656 2 necklace Clasp 0.439 68.0

07

- 810

- 4656 3 neck lace Pendant (pink) 0.808

07

- 810

- 4656 3 necklace Clasp 53 6 758 112 8 7242 2421 966 4

07

- 810

- 4656 4 necklace Pendant (pink) 4.9 1.5 0.3 0.9 6.7 7.6

07

- 810

- 4656 4 necklace Clasp 45 9 62 3 1203 6730 2285 901 5

07

- 810

- 4656 5 nec klace Pendant (blue) 1.9 0.6 0.4 2.2 2.9 5.1

07

- 810

- 4656 6 necklace Pendant (blue) 0.192

07

- 810

- 4674 1 necklace pendant 1.82 0.05 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4674 1 necklace hook 0.16 0.012 0.2 0.0 0.0 0.2 0.2 0.4

07

- 810

- 4674 2 ne cklace pendant 1.84 0.068 0.9 0.0 0.0 0.0 0.9 0.9

07

- 810

- 4674 2 necklace hook 0.16 0.017 0.2 0.0 0.0 0.5 0.2 0.7

07

- 810

- 4675 1 necklace pendant 5.373 3.7 0.6 1.4 3.9 5.7 9.2

07

- 810

- 4675 1 necklace hook 0.177 0.1 0.1 0.0 0.0 0.2 0.2

07

- 810

- 4675 2 ne cklace pendant 5.333 1.7 1.4 0.0 2.6 3.1 8.2

07

- 810

- 4675 2 necklace hook 0.171 0.0 0.1 0.0 0.0 0.1 0.2

07

- 810

- 4675 4 necklace pendant 5.14 0.02

07

- 810

- 4675 4 necklace hook 0.174 0.015

07

- 810

- 4675 5 necklace pendant 5.28 0.19 8

07

- 810

- 4675 5 necklace hook 0.166 0.014

07

- 810

- 4703 2 necklace Hook 0.557 81.7 263 709 1180 11085 2152 13237

07

- 810

- 4703 2 necklace pendant 3.274 77.6 616 1028 1634 16926 3278 20204

07

- 810

- 4703 3 necklace Hook 0.537 72.2 979 2037 2485 20878 5501 26379

07

- 810

- 4703 3 necklace pendant 3.037 75.5 1427 2544 4189 21535 8160 29695

07

- 810

- 4704 3 necklace Hook 0.514 76.2 584 1446 2289 17316 4319 21635

07

- 810

- 4704 3 necklace pendant 2.964 92.1 244 52.0 57.0 846 353 1199

07

- 810

- 4704 4 necklace Hook 0.587 70.3 572 1629 2608 18961 4809 23770

07

- 810

- 4704 4 necklace pendant 2.345 89.8 52.0 14.0 25.0 198 91.0 289

07

- 810

- 4705 1 necklace Hook 0.572 91.6 572 1404 2228 17058 4204 21262

07

- 810

- 4705 1 necklace pendant 2.471 86.9 14.0 42.0 24.0 2198 80.0 2278

07

- 810

- 4705 2 necklace Hook 0.581 85.6 1189 2958 5352 22800 9499 32299

### 17 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3

= 6 1+2+3+18

=24

1 2 3 18

07

- 810

- 4705 2 necklace pendant 2.184 79.9 133 42.0 53.0 1853 228 2081

07

- 810

- 4711 4 earring metal 1.058 0.049 8.4 3.3 2.5 2.5 14.2 16.7

07

- 810

- 4711 5 earring metal 1.426 0. 051 6.5 6.1 5.2 4.4 17.8 22.2

07

- 810

- 4724 6 hair clip,

green 0.001

07

- 810

- 4724 6 hair clip, purple 0.003

07

- 810

- 4724 6 hair clip, red 0.529 0.3 0.0 0.0 0.5 0.3 0.8

07

- 810

- 4724 6 hair clip, yellow 0.547 0.0 0.0 0. 0 0.5 0.0 0.5

07

- 810

- 4725 1 pin 11.02 88.4 33 4 130 3 7660 90173 929 7 9947 1

07

- 810

- 4725 3 pin 10.94 90.1 440 114 2 388 1 66501 546 3 71964

07

- 810

- 4946 1 anklet pendant 3.18 53.4 44 8 121 7 30 70 17505 4734 22240

07

- 810

- 4946 3 anklet pendant 3.16 50.5 1 821 3197 6849 35960 11867 47828

07

- 810

- 4946 5 anklet pendant 2.58 16.5 90.7 166 377 7424 634 8058

07

- 810

- 4946 6 anklet pendant 2.86 54.7 28.1 111.4 224.5 8375 364 8739

07

- 810

- 4947 3 Bracelet Connector 0.1209 0.010 0.1 0.1 0.1 0.1 0.4 0.5

07

- 810

- 4947 3 Pendant 1 0.9423 0.201 0.5 0.3 0.4 1.0 1.2 2.2

07

- 810

- 4947 3 Pendant 2 1.1407 0.100 2.0 0.9 0.7 0.4 3.6 3.9

07

- 810

- 4947 5 Connector 0.1213 0.013 0.2 0.1 0.1 0.3 0.4 0.7

07

- 810

- 4947 5 Pendant 1 0.8961 0.481 0.4 0.3 0.4 0.8 1.2 2.0

07

- 810

- 4947 5 Pendant 2 1.3189 0.104 0.8 0.4 0.4 0.3 1.6 1.9

07

- 810

- 4948 2 Bracelet charm, P 1.064 0.059 2.9 0.0 0.0 0.0 2.9 2.9

07

- 810

- 4948 2 charm, S 1.035 0.093 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4948 4 charm, P 1.081 0.077 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 4948 4 charm, S 1.151 0.046 4.7 0.0 0.0 0.0 4.7 4.7

07

- 810

- 5001 1 kit chain 3.11 0.04 64.4 5.8 2.0 0.5 72.2 72.7

07

- 810

- 5001 1 kit hook 0.495 0.017 1.1 0.3 0.2 0.3 1.6 1.9

07

- 810

- 5001 1 kit charm

- bag 0.872 0.019 0.2 0.2 1.5 0.2 1.9 2.1

07

- 810

- 5 001 1 kit charm

- dog 0.997 0.017 0.2 0.2 0.3 0.0 0.6 0.7

07

- 810

- 5001 2 kit chain 3.301 0.006 5.7 1.5 0.2 0.0 7.4 7.4

07

- 810

- 5001 2 kit hook 0.485 0.024 0.5 0.4 0.5 0.5 1.3 1.8

07

- 810

- 5001 2 kit charm

- bag 0.758 0.013 0.4 3.0 0.6 0.1 3.9 4.1

07

- 810

- 5001 2 kit charm

- dog 0.933 0.009 1.2 0.3 0.2 0.3 1.7 2.0

07

- 810

- 5002 1 necklace pendant 1.505 79.5 33.1 75.3 98.0 1625 206 183 2

07

- 810

- 5002 1 necklace hook 0.188 0.018 0.0 0.2 0.0 0.1 0.2 0.3

07

- 810

- 5002 5 necklace pendant 1.37 74 161 227 302 1506 69 1 219 7

07

- 810

- 5002 5 necklace hook 0.186 0.255 0.0 0.0 0.0 0.5 0.0 0.5

07

- 810

- 5027 3 earring 0.024

07

- 810

- 5027 4 necklace chain 1.24 0.007 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5027 4 necklace pendant 1.93 0.011 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 502 7 4 necklace hook 0.27 0.016 0.0 0.0 0.0 0.3 0.0 0.3

07

- 810

- 5027 4 earring 0.44 0.2 0.0 0.0 0.0 0.2 0.2

### 18 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3

= 6 1+2+3+18

=24

1 2 3 18

07

- 810

- 5027 6 necklace pendant 1.79 0.023 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5027 6 necklace hook 0.25 0 0.4 0.0 0.0 0.0 0.4 0.4

07

- 810

- 5027 6 earring 0.4 0.011 0.0 0.6 0.0 0.2 0.6 0.8

07

- 810

- 5028 1 nec klace charm 0.021

07

- 810

- 5028 1 necklace hook 85.5

07

- 810

- 5028 2 necklace charm 0.041

07

- 810

- 5028 2 necklace hook 0.021

07

- 810

- 5028 4 necklace charm 2.24 0.159 1.2 0.0 0.0 0.0 1.2 1.2

07

- 810

- 5028 4 necklace hook 0.49 0.045 0.4 0.3 0.0 0.0 0.7 0.7

07

- 810

- 5028 5 necklace hook 0.75 94.5 249 58 3 110 5 9331 1937 1126 9

07

- 810

- 5028 6 necklace charm 1.93 0.041 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5028 6 necklace hook 0.49 0.027 0.0 0.0 0.0 0.0 0.0 0.0

07

- 8 10

- 5032 1 spring

bracelet 2.580 0.003 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5032 5 spring

bracelet 2.618 0.002 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5033 2 metal ring 1.3285 0.003 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5033 5 metal ring 2.3045 0.015 0.0 0.0 0.0 0.0 0 .0 0.0

07

- 810

- 5035 3 necklace charm 0.721 0.101 55.1 0.0 0.0 0.9 55.1 56.0

07

- 810

- 5035 6 necklace charm 0.653 0.085 190.5 5.2 1.8 4.6 19 8 202

07

- 810

- 5121 4 necklace pendant 7.1 81.92 32.0 5.3 17.4 73591 54.7 73646

07

- 810

- 5121 4 necklace hook 0.77 85. 7 947 221 4 2566 23251 5727 2897 9

07

- 810

- 5121 6 necklace pendant 7.36 84.67 475 3 10 379.4 40443 1164 4160 8

07

- 810

- 5121 6 necklace hook 0.61 82.28 976 187 9 11 90 3128 4045 717 4

07

- 810

- 5122 5 ring 0.006 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5122 6 ring 0.008 0.0 33.0 33.0

07

- 810

- 5126 2 necklace chain 3.62 0.005 0.0 0.0 1.9 9.4 1.9 11.3

07

- 810

- 5126 5 necklace chain 2.81 0.012 0.0 0.0 1.5 6.9 1.5 8.4

07

- 810

- 5126 5 necklace pendant 2 0.004 0.0 0.0 0.0 2.5 0.0 2.5

07

- 810

- 5127 1 ring 1.88 0.0 05 0.0 0.0 0.0 5.9 0.0 5.9

07

- 810

- 5127 6 ring 2.91 0.005 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5128 2 necklace pendant 0.996 0.017 0.0 0.8 0.5 1.3 1.3

07

- 810

- 5128 3 necklace pendant 1.081 0.004 2.6 2.6 1.7 4.8 6.9 11.7

07

- 810

- 5128 4 necklace pendant 1.187 0.006 0.7 1.0 1.1 3.6 2.8 6.4

07

- 810

- 5128 5 necklace pendant 0.872 0.008 0.0 0.4 0.7 1.9 1.1 3.0

07

- 810

- 5176 1 necklace key shaped pendant 0.004

07

- 810

- 5176 1 necklace heart shaped pendant 0.001

07

- 810

- 5176 1 necklace crown shaped pendant 0.002

07

- 810

- 5176 4 necklace key shaped pendant 0.539 0.029 0.3 0.3 0.3 0.3 0.9 1.2

### 19 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Ac id Extraction Time (hour) 1+2+3

= 6 1+2+3+18

=24

1 2 3 18

07

- 810

- 5176 4 necklace heart shaped pendant 0.394 0.003 0.2 0.2 0.2 0.5 0.6 1.1

07

- 810

- 5176 4 necklace crown shaped pendant 1.099 0 0.5 1.0 0.3 0.6 1.8 2.4

07

- 810

- 5176 6 necklace key shaped pendant 0.561 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5176 6 necklace heart shaped pendant 0.396 0.0 0.2 0.0 0.5 0.2 0.7

07

- 810

- 5176 6 necklace crown shaped pendant 1.021 0.0 0.0 0.0 0.0 0.0 0.0

07

- 810

- 5177 2 Bracelet key shaped cross pendant 1.465 86.5 7928 1649 8389 43384 17966 61350

07

- 810

- 5177 2 Bracelet curved shape cross pendant 1.473 57.3 896 506 938 7560 2340 9900

07

- 810

- 5177 2 Bracelet square cross 1.264 60.4 993 155 524 3166 1672 4838

07

- 810

- 5177 2 Bracelet thick cross

p endant 2.897 92.5 6840 2909 6944 34119 16693 50812

07

- 810

- 5177 2 Bracelet Hook 0.922 81.3 657 199 3643 36763 4499 41262

07

- 810

- 5177 6 Bracelet key shaped cross pendant 1.754 92.7 1460 348 2498 14250 4306 18556

07

- 810

- 5177 6 Bracelet curved shape cross pendant 1.347 63.7 678 267 1071 3623 2016 5639

07

- 810

- 5177 6 Bracelet square cross pendant 1.219 68.6 1452 374 2761 5051 4587 9638

07

- 810

- 5177 6 Bracelet thick cross pendant 2.909 83.1 3450 1572 2262 44240 7284 51524

07

- 810

- 51 77 6 Bracelet Hook 1.096 80.6 700 34.2 4194 33726 4920 38646

07

- 810

- 5178 4 Choker Large Butterfly

charm 3.838 82.5 2083 774 4825 31284 7362 38986

07

- 810

- 5178 4 Choker small butterfly

charm 1.827 90.9 968 1028 2002 9746 3998 13744

07

- 810

- 51 78 4 Choker large heart

charm 3.472 53.3 4447 2298 3591 35057 10336 45393

07

- 810

- 5178 4 Choker Heart with crystal charm 2.197 91.6 2859 2716 3678 191066 9253 28359

07

- 810

- 5178 4 Choker Hook 0.754 78.1 293 956 1820 7128 3069 10197

07

- 810

- 51 78 6 Choker Large Butterfly

charm 4.254 88.6 1957 2189 5292 34428 9438 43866

07

- 810

- 5178 6 Choker small butterfly

charm 1.937 91 1418 1724 4385 23742 7527.0 31269

### 20 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extr acted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3

= 6 1+2+3+18

=24

1 2 3 18

07

- 810

- 5178 6 Choker large heart

charm 3.074 77.9 10158 2311 6428 34604 18897 53501

07

- 810

- 5178 6 Choker Heart with crystal charm 2.09 4 97 2416 5191 1929 7602. 9536 17138

07

- 810

- 5178 6 Choker Hook 0.753 86.4 153 617 1201 3145 1971 5116

07

- 810

- 5221 4 charm 2.677 0.007 0.0 0.0 0.0 1.6 0.0 1.6

07

- 810

- 5221 6 charm 2.684 0.008 1.4 0.0 0.0 1.5 1.4 2.9

07

- 810

- 5259 2 Ring Pend ant 0.8 4.18 2.4 0.4 0.4 0.4 3.2 3.6

07

- 810

- 5259 2 necklace Pendant 0.88 2.2 1.3 0.0 0.4 0.4 1.7 2.1

07

- 810

- 5259 6 Ring Pendant 0.84 0.5 1.3 0.0 0.4 0.8 1.7 2.5

07

- 810

- 5259 6 necklace Pendant 0.8 0.59 0.4 0.0 0.0 0.4 0.4 0.8

07

- 810

- 5260 2 Ring pendant 0.47 0.303 0.2 0.2 0.2 0.2 0.7 1.0

07

- 810

- 5260 2 necklace pendant 2.01 0.166 1.0 0.0 1.0 0.0 2.0 2.0

07

- 810

- 5260 5 Ring pendant 0.49 2.333 0.5 0.3 0.5 0.3 1.3 1.5

07

- 810

- 5260 5 necklace pendant 2 0.363 0.0 0.0 1.0 1.0 2.0

07

- 810

- 5260 5 necklace shoe pendant 1.64 0.118 0.8 0.0 0.8 1.6 1.6 3.3

07

- 810

- 5261 1 necklace butterfly pendant 1.66 0.114 0.0 0.0 0.8 0.8 0.8 1.7

07

- 810

- 5261 1 necklace ladybug pendant 1.36 1.922 0.0 0.0 0.0 0.7 0.0 0.7

07

- 810

- 5261 1 necklace clover pendant 1.26 1.188 2.5 0.6 0.6 0.6 3.8 4.4

07

- 810

- 5261 4 necklace butterfly pendant 1.62 1.305 4.9 0.8 0.8 0.8 6.5 7.3

07

- 810

- 5261 4 necklace ladybug pendant 1.42 0.556 4.3 0.0 0.7 0.7 5.0 5.7

07

- 810

- 5261 4 necklace clover pendant 1.2 0.435 0.0 0.0 0.0 0.6 0.0 0.6

07

- 810

- 5275 2 Bra celet charm 1.135 0.015 26.0 0.9 1.4 2.1 28.4 30.4

07

- 810

- 5275 5 Bracelet charm 1.154 0.007 0.4 0.0 0.0 1.2 0.4 1.5

07

- 810

- 5276 2 Bracelet charm 0.494 0.013 116.1 4.7 1.8 2.9 122 125

07

- 810

- 5276 2 Bracelet 0.53 0.008 4.5 0.6 0.2 2.0 5.2 7.3

07

- 810

- 5276 5 Bracelet charm 1.377 0.578 29.5 21.1 29.8 391 80.4 471

07

- 810

- 5276 5 Bracelet 0.476 0.008 1.0 0.4 0.2 1.7 1.7 3.3

07

- 810

- 5277 2 necklace clasp 0.494 0.116 19.0 0.1 2.3 45.7 21.4 67.1

07

- 810

- 5277 2 necklace 0.53 0.385 5.5 3.1 2.0 12.8 10.6 2 3.4

07

- 810

- 5277 5 necklace clasp 1.377 0.117 2.0 2.8 4.8 33.5 9.6 43.0

07

- 810

- 5277 5 necklace 0.476 0.24 4.7 2.0 1.5 12.6 8.2 20.8

07

- 810

- 5645 2 ring 0.086

07

- 810

- 5645 3 ring 0.091

07

- 810

- 5645 6 ring 4.6 2.3 4.4 11.3

07

- 840

- 6040 2 ring 0.904 0.043 4.3 2.2 2.5 43.6 9.0 52.6

07

- 840

- 6040 3 ring 0.702 0.042 1.6 1.5 2.4 13.5 5.5 19.0

### 21 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3 =

6 1+2+3+

18=24

1 2 3 18

07

- 840

- 6041 2 necklace pendant 2.857 0.005 0.0 0.0 0.0 1.1 0.0 1.1

07

- 840

- 6041 2 chain 2.526 0.006 0.0 0.0 0.0 2.9 0.0 2.9

07

- 840

- 6041 6 ring 0.485 0.005 0.0 0.0 0.3 0.0 0.3 0. 3

07

- 840

- 6042 1 body claps charm 0.708 0.015 1.0 0.0 0.0 0.6 1.0 1.6

07

- 840

- 6042 4 body claps charm 0.384 0.006 0.3 0.0 0.0 6.4 0.3 6.7

07

- 840

- 6042 5 body claps charm 0.526 0.01 0.0 0.4 0.0 0.0 0.4 0.4

07

- 840

- 6137 2 necklace pendant 2.51 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6137 2 necklace hook 0.48 0.5 0.3 0.0 0.7 0.8 1.5

07

- 840

- 6137 4 necklace pendant 0.012

07

- 840

- 6137 4 necklace hook 0.03

07

- 840

- 6137 5 necklace pendant 2.66 6.7 0.0 0.0 0.0 6.7 6.7

07

- 840

- 6137 5 neckla ce hook 0.55 0.3 0.0 0.0 0.0 0.0 0.3

07

- 840

- 6137 6 necklace pendant 0.058

07

- 840

- 6137 6 necklace hook 0.055

07

- 840

- 6138 5 necklace Pendant 5.3 0.036 10.4 0.0 0.0 0.0 10.4 10.4

07

- 840

- 6138 5 necklace Hook 0.48 0.006 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6138 6 necklace Pendant 5.26 0.036 11.5 0.0 0.0 0.0 11.5 11.5

07

- 840

- 6138 6 necklace Hook 0.5 0.012 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6139 1 charm charm 0.013

07

- 840

- 6139 2 charm charm 0.01

07

- 840

- 6139 4 charm charm 2.34 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6139 5 charm charm 2.32 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6143 1 necklace Clasp 0.99 0.009

07

- 840

- 6143 2 necklace Pendant 0.6342 0.031

07

- 840

- 6143 3 necklace Pendant 1.1 0.3 0.1 1.4 2.9

07

- 840

- 6143 4 necklace Clasp 0.0985 0.012

07

- 840

- 6143 5 necklace Pendant 0.6301 0.008

07

- 840

- 6143 7 necklace Pendant 0.4 0.7 0.1 1.1 2.3

07

- 840

- 6143 3,7, 2

, 5 necklace 4 Clasps 1.0 0.2 0.0 1.1 2.3

07

- 84 0

- 6169 3 necklace Pendant 2.6156 87.4 357 6054 8620 59429 15031 74461

07

- 840

- 6169 4 necklace Pendant 1.9664 84.3 16 10 303 8 4132 5293 8 87 80 61717

07

- 840

- 6170 3 necklace Pendant 5.289 0.02 12.4 4.7 2.8 5.4 19.9 25.3

07

- 840

- 6170 4 necklace Pendant 4.851 0.46 2.4 2.1 2.4 71.4 6.9 78.4

07

- 840

- 6187 1 necklace pendant 3.14 0.867 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6187 4 necklace pendant 0.144

07

- 840

- 6187 5 necklace pendant 2.84 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6187 6 necklace pendant 2.1 4.1 0.9 0.0 0.0 5.0 5.0

07

- 840

- 6188 1 necklace pendant 0.064

07

- 840

- 6188 2 necklace pendant 1.34 7.2 0.0 0.0 0.0 7.2 7.2

07

- 840

- 6188 3 necklace pendant 0.045

07

- 840

- 6188 4 necklace pendant 1.64 2.3 0.0 0.0 1.2 2.3 3.5

07

- 8 40

- 6188 6 necklace pendant 1.3 3.7 0.0 0.0 1.0 3.7 4.7

### 22 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3 =

6 1+2+3+

18=24

1 2 3 18

07

- 840

- 6190 1 necklace chain 0.007

07

- 840

- 6190 4 necklace chain 0.013

07

- 840

- 6224 3 Ring

necklace Ring 2.969 0.002 0.0 0.4 0.6 0.0 1.0 1.0

07

- 840

- 6224 3 Ring

necklace pendant 2.800 0.008 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6224 5 Ring

necklace Ring 2.946 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6224 5 Ring

necklace pendant 2.885 0.004 0.3 0.0 0.0 0.0 0.3 0.3

07

- 840

- 6225 4 necklace pendant 3.712 0.006 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6225 4 necklace pendant 3.455 0.003 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6225 6 necklace pendant 3.525 0.003 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6225 6 necklace pendant 3.544 0.003 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6238 1 necklace pendant 6.166 91. 1 10.4 55.6 75.9 585 14 2 727

07

- 840

- 6238 1 necklace tear drops 0.4 74 84. 8 228 286 318. 1576 83 3 2409

07

- 840

- 6238 1 necklace clasp 0.62 88.9 12 10 1975 280 6 1589 1 5990 21881

07

- 840

- 6238 2 necklace pendant 5.702 52.5 38.3 75.5 98.7 64 7 212 859

07

- 840

- 6238 2 necklace tear drops 0.474 84. 7 3.4 0.3 4.6 6921 8. 2 6929

07

- 840

- 6238 2 necklace clasp 0.636 85. 2 1585 31 10 537 2 3121 8 10067 4128 5

07

- 840

- 6320 1 Bracelet bracelet 5.73 0.128 0.0 0.4 1.0 2.6 1.4 3.9

07

- 840

- 6320 2 Bracelet bracelet 5.57 0.021 0.0 0.0 1.8 3.2 1.8 5.0

07

- 840

- 6321 1 Ring Ring 2.99 0.063 0.0 0.0 0.0 4.7 0.0 4.7

07

- 840

- 6321 2 Ring Ring 3.26 0.063 0.0 0.3 5.5 0.0 5.9 5.9

07

- 840

- 6356 2 necklace charm 3.184 0.021 2.0 1.5 10.0 14.2 13.5 27.7

07

- 840

- 6356 2 necklace clasp 0.35 0.031 2.3 1.7 3.5 0.3 7.4 7.7

07

- 840

- 6356 5 necklace charm 2.901 0 .034 3.8 3.5 4.9 12.2 12.2 19.5

07

- 840

- 6356 5 necklace clasp 0.35 0.03 86.1 4.7 3.1 93.9 93.9 94.9

07

- 840

- 6357 2 necklace pendant 2.316 0.005 15.5 0.3 0.7 1.1 16.5 17.6

07

- 840

- 6357 5 necklace pendant 2.281 0.006 1.7 0.0 0.6 0.3 2.3 2.5

07

- 840

- 6397 4 Br acelet hook 0.0988 0.002 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6397 5 Bracelet hook 0.0974 0.000 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6397 4 Bracelet chain 0.5115 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6397 5 Bracelet chain 0.529 0.006 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6398 4 Bracelet chain 0.4098 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6398 4 Bracelet hook 0.0826 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6398 4 Bracelet charm 0.8434 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6398 6 Bracelet chain 0.3988 0.001 0.0 0.0 0.0 0.0 0.0 0 .0

07

- 840

- 6398 6 Bracelet hook 0.0919 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6398 6 Bracelet charm 0.8075 0.000 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6399 1 Bracelet chain 0.3781 0.000 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6399 1 Bracelet hook 0.085 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6399 1 Bracelet charm 0.5921 0.001 1.4 1.5 3.5 0.0 6.4 6.4

07

- 840

- 6399 2 Bracelet chain 0.361 0.001 0.0 0.0 0.5 0.0 0.5 0.5

### 23 Sample Sub Sample Type Parts Weight (grams) % Pb μg of Pb extracted Total Extractable

P b, μg

Acid Extraction Time (hour) 1+2+3 =

6 1+2+3+

18=24

1 2 3 18

07

- 840

- 6399 2 Bracelet hook 0.095 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6399 2 Bracelet charm 0.573 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6400 5 Bracelet hook 0.0925 0.0 02 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6400 5 Bracelet chain 0.542 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6400 6 Bracelet hook 0.1001 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6400 6 Bracelet chain 0.5167 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6401 2 ring Ring 0.326 0.002 0.2 0.0 0.0 0.0 0.2 0.2

07

- 840

- 6401 3 ring Ring 0.293 0.001 0.3 0.1 0.0 0.0 0.4 0.4

07

- 840

- 6402 2 ring Ring 0.2545 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6402 6 ring Ring 0.327 0.001 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6411 2 necklace pendant 1.432 0 0 .6 0.2 0.1 0.3 0.8 1.1

07

- 840

- 6411 1 necklace pendant 0.965 0 0.8 0.2 0.4 2.0 1.5 3.5

07

- 840

- 6412 1 necklace pendant 6.958 0 1.6 0.5 0.5 0.7 2.6 3.3

07

- 840

- 6412 2 necklace pendant 11.306 0 7.9 0.3 0.6 1.6 8.9 10.4

07

- 840

- 6428 4 ring set ring 1 1.024 0. 218 1.4 0.7 1.1 4.5 3.2 7.7

07

- 840

- 6428 4 ring set ring 3 1.141 0.065 5.0 4.2 0.8 0.8 10.0 10.8

07

- 840

- 6428 6 ring set ring 1 1.296 92.7 14.4 29.0 48.1 25 5 91.5 346

07

- 840

- 6428 6 ring set ring 3 1.238 0.048 0.6 0.0 0.0 0.9 0.6 1.5

07

- 840

- 6429 3 neckla ce Pendant 1.493 0.031 0.0 0.0 0.0 0.7 0.0 0.7

07

- 840

- 6429 4 necklace Pendant 1.574 0.03 0.0 0.0 0.0 1.0 0.0 1.0

07

- 840

- 6465 1 necklace Pendant 19.0 37.9 7.5 56.8 64.4 121

07

- 840

- 6465 2 necklace Pendant 4.8 1.6 4.8 6.4 11.2 28.8

07

- 840

- 6465 5 necklace Pendant 7.996 0.062

07

- 840

- 6465 6 necklace Pendant 8.0217 0.045

07

- 840

- 6466 1 bracelet 850 8.5 0.0 0.0 0.0 8.5 8.5

07

- 840

- 6466 3 bracelet 0.006

07

- 840

- 6466 4 bracelet 0.005

07

- 840

- 64 66 5 bracelet 867 0.0 0.0 0.0 0.0 0.0 0.0

07

- 840

- 6518 1 necklace pendant 9.317 0.011 1.6 0.0 0.1 0.5 1.7 2.8

07

- 840

- 6518 1 necklace pendant 2.891 0.01 1.1 0.2 0.0 0.2 1.3 1.5

07

- 840

- 6518 2 necklace pendant 9.066 0.008 1.0 1.6 0.5 0.7 3.1 3.8

07

- 840

- 6518 2 necklace pendant 2.845 0.01 0.8 0.3 0.6 0.3 1.7 2.0

07

- 840

- 6519 1 mixed pendant 2.206 0.01 4.2 0.8 0.2 0.2 5.2 5.4

07

- 840

- 6519 2 mixed pendant 2.265 0.01 1.3 0.6 0.2 0.1 2.1 2.2

07

- 840

- 6520 1 necklace pendant 3.261 nd 2.4 0.5 0.6 0.3 3.5 3.8

07

- 840

- 6520 1 necklace pendant 4.183 nd 1.6 0.2 0.0 0.0 1.7 1.7

07

- 840

- 6520 2 necklace pendant 2.503 nd 0.6 0.7 0.0 0.3 1.3 1.6

07

- 840

- 6520 2 necklace pendant 4.238 nd 2.7 0.0 0.2 1.6 2.8 4.4

### 24 Sample Sub Sample Type Par ts Weight (grams) % Pb μg of Pb extracted Total Extractable Pb, μg

Acid Extraction Time (hour) 1+2+3 =

6 1+2+3+

18=24

1 2 3 18

07

- 840

- 6787 1 necklace charm 10.08 0.023 8.5 0.0 0.0 37.1 8.5 

### 45.6

07

- 840

- 6787 1 necklace clas p 0.39 0.063 2.5 2.5 5.6 23.6 10.6 

### 34.2

07

- 840

- 6787 2 necklace charm 9 0.193 0.0 0.0 0.0 38.9 0.0 

### 38.9

07

- 840

- 6787 2 necklace clasp 0.42 0.066 1.0 1.9 4.0 6.9 

### 6.9

07

- 840

- 6788 1 Bracelet bracelet 4.48 0.028 1.6 0.0 0.0 2.1 1.6 3.6

07

- 840

- 6788 2 Bracel et bracelet 4.54 0.047 0.7 0.0 0.0 1.1 0.7 1.8

07

- 840

- 6969 3 necklace Hook 0.432 67.5 629 1392 3566 8954 5587 14541

07

- 840

- 6969 5 necklace Hook 0.615 52.2 472 1608 3380 10029 5460 15489

07

- 840

- 7061 6 Bracelet charm 88.7 353 73 4 1165 17 474 2252 19726

07

- 840

- 7061 6 Bracelet ring 1 87.2 234 549 1130 13529 191 4 1544 3

07

- 840

- 7061 6 Bracelet ring 2 87.1 63.4 51.8 53.9 257 3 169 274 2

07

- 840

- 7061 6 Bracelet hook 84.8 87 4 169 6 2291 290 50 4860 33910

07

- 840

- 7061 6 Bracelet tear drop 89.9 144 18 2 239 1277 56 5 184 2

07

- 840

- 7061 8 Bracelet charm 85.4 810 12 10 1415 1085 8 3435 1429 3

07

- 840

- 7061 8 Bracelet ring 1 89 806 1756 2757 2787 1 53 20 3319 1

07

- 840

- 7061 8 Bracelet ring 2 84.8 767 1459 187 5 1609 7 4101 20198

07

- 840

- 7061 8 Bracelet hook 86 73 7 1801 249 5 1870 4 5032 23736

07

- 840

- 7061 8 Bracelet tear drop

charm 85.4 226 3 40 36 6 1955 931 288 7

07

- 840

- 7064 21 Bracelet charm 11.52 89.2 1931 4205 16685 137393 2282 2 160214

07

- 840

- 7064 21 Bracelet link 2. 597 89.3 2223 3300 3869 30166 9292.4 3945 9

07

- 840

- 7064 21 Bracelet clasp 2.539 91.8 22 20 369 9 4799 3851 3 1061 2 4912 5

07

- 840

- 7064 22 Bracelet charm 10.015 94.5 2412 6228 1329 8 109385 21938 131323

07

- 840

- 7064 22 Bracelet link 2.701 87.0 280 5 3591 3 676 2569 6 10072 35768

07

- 840

- 7064 22 Bracelet clasp 2.262 94.9 430 567 5 7267 39761 13372 5313 4

07

- 840

- 7171 3 ring 5.78 11.9 85.0 11 4 167 968 366 1334

07

- 840

- 7171 5 ring 5.57 6.52 23 8 288 457 2923 983 3906

07

- 840

- 7172 4 necklace penda nt 9.57 1.37 5.8 0.0 0.0 33.3 5.8 39.1

07

- 840

- 7172 4 necklace hook 0.55 88.9 274 459 673 223 3 140 6 3638

07

- 840

- 7172 7 necklace pendant 8.14 0.50 0.00 0.00 0.00 0.00 0.00 0.00

07

- 840

- 7172 7 necklace hook 0.54 89.3 663 931 1735 970 2 3329 130 30

07

- 840

- 7173 8 ring #1 solder 5.676 13.7 404 572 733 317 5 17 10 48 85

07

- 840

- 7173 8 ring Crown solder 5.626 1.65 130 85 39 2 30 254 484

07

- 840

- 7173 8 ring ring metal 0.006

07

- 840

- 7174 5 ring 1.559 0.266 764 1023 157 2 486 2 3358 8220

07

- 840

- 7174 5 chain 0.973 0.00 1 2.8 0.0 0.0 0.0 2.8 2.8

07

- 840

- 7174 8 ring 1.589 1.2 1 6 90 119 8 187 2 7281 3759 1104 1

07

- 840

- 7174 8 chain 0.99 0.006 0.7 1.0 0.0 0.0 1.7 1.7

### 25 

## Table 2. Non

- Met al Jewelry Results

Sample Sub Sample Type Parts Material Weight g * XRF % Pb μg Pb

1st 24

hours μg Pb

2 nd 24

hours Total μg Pb

48

hours Pb Lα Pb Lß

07

- 302

- 0045 1 necklace cord PVC 1.68 7.6 3.3 0.039 26.9 14 41

07

- 302

- 0046 1 necklace crystal crystal 116.9 107.6 23.5

07

- 302

- 0046 1 necklace crystal crystal 88 101 17.3

07

- 810

- 4076 2 bracelet plastic (ABS) nd nd

07

- 810

- 4076 2 ring plastic(ABS) nd nd

07

- 810

- 4076 2 hair clip plastic (ABS) nd n d

07

- 810

- 4076 3 false nails plastic (ABS) 1.3 nd

07

- 810

- 4076 3 ring plastic (ABS) nd nd

07

- 810

- 4076 6 false nails plastic (ABS) nd nd

07

- 810

- 4077 4

, 5 Ring plastic 0.7258 0.283/2.

283 0/0.8 0.0013

07

- 810

- 4173 1 necklace Crystal from
pendant crystal 465 507 13.57

07

- 810

- 4173 2 necklace Crystal from

“diamond” earring crystal 13.68

07

- 810

- 4294 1 beads/stone) Epoxy Resin ND ND

07

- 810

- 4294 3 beads/stone) Epoxy Resin ND ND

07

- 810

- 4294 5 Ring beads/stone) Epoxy Resin ND ND

07

- 810

- 4294 5 Ring beads/stone) crystal 14.8

07

- 810

- 4294 5 Ring beads/stone) Epoxy Resin ND ND

07

- 810

- 4654 2 ring plastic(meth yl acrylate)

gemstone nd nd

07

- 810

- 4711 4 earring crystal crystal 0.015

07

- 810

- 4711 5 earring crystal crystal 0.051

07

- 810

- 4948 2 Beads(5x) plastic (PVC) 0.4416 388 361 0.198 2.74 1.82 4.56

07

- 810

- 4948 4 Beads(5x) plastic (PVC) 0.4428 388 3 61 0.202 4.80 0.24 5.04

07

- 810

- 5027 2 necklace pendant glass crystal 0.064

07

- 810

- 5027 3 earring glass crystal 92 65 0.549

07

- 810

- 5027 3 necklace pendant glass crystal 0.083 2.6 1.3 3.9

07

- 810

- 5034 2 necklace bead plastic (A BS)

with metal

foil 3.5 ND 0.01 0.4 0.8 1.2

07

- 810

- 5034 4 necklace bead plastic (ABS)

with metal

foil 6.5 ND 0.014 0.6 0.3 0.9

07

- 810

- 5034 5 necklace green bead plastic (ABS)

with metal

foil 3.2 ND 0.014 0.2 0.4 0.6

07

- 810

- 5034 5 necklace gold bead plastic (ABS)

with metal

foil 2.8 ND 0.026 0.2 0.2 0.4

07

- 810

- 5222 3 necklace cord plastic (PVC) 2.45 0.596 85.2 105.1 190.3

### 26 Sample Sub Sample
Type Parts Material Weight g * XRF

% Pb μg Pb

1st 24

hours μg Pb

2 nd 24

hours Total μg P b

48

hours Pb Lα Pb Lß

07

- 810

- 5222 3 necklace bead plastic 0.4026 0 0 0

07

- 810

- 5222 4 necklace cord plastic (PVC) 2.58 0.604 81.1 101.2 182.3

07

- 810

- 5222 4 necklace bead plastic 0.4205 0 0 0

07

- 810

- 5178 4 Choker crystal 0. 0387 12

07

- 810

- 5178 4 Choker collar plastic (PVC) 166 202 0.48 298 292 590

07

- 810

- 5178 6 Choker crystal 0.0347 17.2

07

- 810

- 5178 6 Choker collar plastic (PVC) 0.83 146 117 262

07

- 810

- 5259 2&6 Ring Pendant crystal 0

07

- 810

- 5259 2&6 necklace Pendant crystal 0

07

- 810

- 5260 2 Ring bead crystalline

bead 0.035 6.5 1.2 7.7

07

- 810

- 5260 2 necklace bead crystalline

bead 0 22.3 0.9 23.3

07

- 810

- 5260 5 Ring bead crystalline

bead 0.041 22.2 12 34.2

07

- 810

- 5260 5 necklace bead crystalline

bead 0 0 0 0

07

- 810

- 5260 2&5 necklace pendant crystal 0

07

- 810

- 5261 1 necklace beads crystalline

bead 0.01 0 0

07

- 810

- 5261 4 necklace beads crystalline

bead 0.018 0 0

07

- 81 0

- 5261 1&4 necklace butterfly pendant crystal 0

07

- 840

- 6137 4 necklace crystal glass crystal 5.9

07

- 840

- 6137 6 necklace crystal glass crystal 7.54

07

- 840

- 6137 ** necklace crystal glass crystal 0.0705 0.8 0.4 1.2

07

- 840

- 6171 4 necklace charm plastic 6.136 0.01 0 0 0

07

- 840

- 6171 4 necklace chain plastic 13.78 0.01 0 0 0

07

- 840

- 6171 8 necklace charm plastic 6.167 0.012 0 0 0

07

- 840

- 6171 8 necklace chain plastic 13.85 0.005 0 0 0

07

- 840

- 6172 5 br acelet bead plastic 0.474 0.001 0.4 0 0.4

07

- 840

- 6172 5 bracelet battery holder plastic 0.534 0.008 1.9 1.3 3.2

07

- 840

- 6172 8 bracelet bead plastic 0.432 0.0004 0.5 0 0.5

07

- 840

- 6172 8 bracelet battery holder plastic 0.527 0.005 1.2 0.3 1.5

07

- 840

- 6189 1 necklace pendant plastic PA nd nd

07

- 840

- 6190 1 necklace pendant plastic PA nd nd

07

- 840

- 6220 4 jeans yellow

rhinestone crystal metal backing 483 360 3.34 30.6 19.8 50.4

07

- 840

- 6220 4 jeans orange
rhinestone cr ystal metal backing 0.035 23.5 14.5 38

07

- 840

- 6220 4 jeans silver

rhinestone crystal (metal backing) 933 970 10.4 0.5 11.7 12.2

### 27 Sample Sub Sample
Type Parts Material Weight g * XRF

% Pb μg Pb

1st 24

hours μg Pb

2 nd 24

hours Total μg P b

48

hours Pb Lα Pb Lß

07

- 840

- 6224 1 Ring

necklace Ring crystal 0.147

07

- 840

- 6224 2 Ring

necklace Ring crystal 0.146

07

- 840

- 6466 3 bracelet glass crystal 22.8

07

- 840

- 6466 4 bracelet glass crystal 25.2

07

- 840

- 6466 *** crystal glass crystal 0.148 2.4 1.8 4.2

07

- 840

- 6519 1 mixed plastic band plastic (PVC) 0.787 30.26 28.36 0.102 24.38 5.43 29.81

07

- 840

- 6519 2 mixed plastic band plastic (PVC) 0.796 0.022 5.86 1.77 7.63

07

- 840

- 69 70 1 necklace painted

wood nd nd

07

- 840

- 7642 3 necklace coated plastic

beads plastic 0.004 2.8 0 2.8

07

- 840

- 7642 4 necklace coated plastic

beads plastic 11.6 0 11.6



## *Note: XRF = x

- ray fluorescence spectroscopy. Items were sc reened using XRF to determine
presence of Pb. The analysis done was qualitative, not quantitative although intensity values for
Pb La and Lb are related to amount of lead present. nd= not detected

**

- 4 subs used

***

- 12 subs used

PA

- Polystyrene Acetoni trile

### 28 

# TAB B: Assessment of Cadmium Migration from Materials 

# T

A

B

B

## U NITED 

## S TATES



## C ONSUMER 

## P RODUCT 

## S AFETY 

## C OMMISSION



## 4330 E AST 

## W EST 

## H IGHWAY



## B ETHESDA 

## , M ARYLAND 

## 20814

Memorandum

CPSC Hotline: 1

- 800

- 638

- CPSC(2772) CPSC's Web Site: http://www.cpsc.gov 

## Date: June 3, 2010

TO : Kristina Hatlelid, Ph.D., M.P.H.
Toxicologist

Division of Health Sciences

THROUGH : Andrew G. Stadnik, P.E., Associate Executive Director, Directorate for
Laboratory Sciences

Joel Recht, Ph.D.

Director

, Laboratory Sciences, Division of Chemistry

FROM : Ian A. Elder, Ph.D.

Chemist

, Laboratory Sciences, Division of Chemistry

SUBJECT : Assessment of Cadmium Migration from Materials 1



## 1.0 EXECUTIVE SUMMARY

In response to concern about cadmium in children’s consumer products, the primary goal
of this study is to produce data that can be used in determining the public health and
clinical significance of exposure to cadmium at levels that may migrate from metal and
plastic materials. Study results may be useful with derived exposure limits for acute and
chronic cadmium toxicity in the establishment of total cadmium content limits similar to
regulations for lead. Products tested for cadmium under the Federal Hazardous Substances
Act are currently evaluated for estimates of exposure lev els using the time

- consuming
migration tests described in this memorandum.

The test procedures used in this study were designed to estimate exposure from products
like children’s jewelry. Migration of cadmium from material surfaces was characterized

with solutions that simulate saliva and gastric acid. The study attempted to correlate total
cadmium content levels with extractable cadmium within specific material types. For

metal

- based materials, the study found that product composition factors, such as ele ment content and coatings, have a larger effect on cadmium migration than does total cadmium
content. Alloys containing zinc were found to leach less cadmium than those that are free

of zinc. Plastics did not leach detectable levels of cadmium.

1 These c omments are those of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views

of, the Commission.30 

## The study plan was also designed to produce information on the accuracy and precision of
analytical techniques used by the U.S. Consumer Product Safety Commission (CPSC) staff
for measuring cadmium content and migration. The development of efficient concentration

b ased referral levels for metal products may be complicated by the effect of coatings on x

ray fluorescence (XRF) analyzer accuracy and the effects of coatings and zinc content on
soluble cadmium migration.

2.0 SCOPE AND APPLICABILITY

Some children’s jewelry products have been found to contain very high levels of cadmium
(Ref. 1). There is concern that migration of cadmium from these products may result in
exposure to toxic levels of cadmium for the children who use such products. The study

described herein ex amines the accessibility of cadmium in metal and plastic materials
containing different levels of cadmium. The cadmium

- containing materials include
reference standards and children’s jewelry products. An understanding of cadmium leach
rates may be useful w hen developing content regulations to ensure that exposures are less

than health

- based limits. The study also evaluates analytical techniques employed by CPSC
staff for the identification of children’s products that are likely to contain hazardous levels

o f accessible cadmium.

Since 2007, CPSC staff has tested a variety of jewelry items for cadmium content and
cadmium solubility. Dilute hydrochloric acid (HCl) and saline are used to simulate the
leaching expected during the digestion and mouthing of materi als, respectively. As
confirmed by Figures 1 and 2, staff perception has been that cadmium solubility is highly

v ariabl e and not necessarily proportional to a material’s cadmium concentration (data
included in Table 1). It seems reasonable to expect reduce d cadmium migration relative to
total cadmium content when a base material is coated (e.g., painted or electroplated) with

cadmium

- free material. Likewise, a coating with cadmium or a cadmium

- containing
material without such a coating could represent a wo r st

- case scenario. The primary issue
this study sought to resolve was whether cadmium solubility is proportional to cadmium
content in homogenous materials.31 

## Figure 1. Soluble migrated c admium from jewelry components with 24

h our s of e xposure to 0 .07N HCl.

Figure 2. Soluble migrated c admium from jewelry components with

s ix h our s of e xposure to 0.9% NaCl.32 

## Table 1. Cadmium Data from Jewelry Analysis

Component Content by

ICP

- OES
(%) Content
by XRF
(%) Migrated into
0.07N HCl, 24h
(μg/g) Migrated into
0.9% NaCl, 6h
(μg/g)

08

- 302

- 2601 Charm 1.32 1.16

- - 08

- 302

- 2600 Charm 1.02 0.923

- - 08

- 302

- 2599 Charm 1.35 1.30

- - 08

- 302

- 2598 Charm 1.32 1.04

- - 08

- 810

- 5399 Ball 22.1

- 0.84

- 08

- 810

- 5399 Big Tree 23.9

- 7.20

- 08

- 810

- 5399 Tree 30.1

- 0.8 5

- 08

- 810

- 5399 Hat 27.5

- 3.04

- 08

- 810

- 5399 Stocking 29.5

- 4.08

- 08

- 840

- 7192 Globe 37.7 15.4

- - 08

- 840

- 7192 Bird 43.6 13.8

- - 08

- 840

- 7306 Charm 36.0

- 83.3 16.7

08

- 840

- 7306 Charm 36.0

- 212 15.5

08

- 840

- 7306 Charm 36.0

- 54.8

- 09

- 810

- 7596 Hoo k 33.4 11.3

- - 09

- 810

- 7596 Link 36.2 12.1

- - 10

- 302

- 2023 Clasp 5.98 1.20 988 455

10

- 302

- 2023 Flake 98.2 28.4 110 228

10

- 302

- 2023 Man 99.1 30.2 2519 21.6

10

- 302

- 2024 Clasp 6.47 1.50 1520 429

10

- 302

- 2024 Tree 85.3 34.1 1374 95.3

10

- 302

- 2024 Cane 96. 1 31.7 773 40.6

10

- 302

- 2024 Deer 99.3 33.2 13668 135

10

- 302

- 2206 Heart 89.9 42.6 10215 49533 

## Table 1 Continued

. Cadmium Data from Jewelry Analysis

Component Content by

ICP

- OES
(%) Content
by XRF
(%) Migrated into
0.07N HCl, 24h
(μg/g) Migrated into

0.9 % NaCl, 6h
(μg/g)

10

- 302

- 2206 Key 0.0285 0.0248 1.21 0.67

10

- 304

- 3090 Flower 19.0 12.3 0.72 0.08

10

- 304

- 3415 Metal 75.5 27.1 9552 122

10

- 304

- 3415 Star 30.3 19.1 40.8 0.88

10

- 304

- 3416 Star 30.7 18.2 140 0.35

10

- 304

- 3417 Heart 36.1 17.2 21.6 5.23

10

- 304

- 3417 U 29.7 13.4 103 0.64

10

- 304

- 3418 Heart 37.7 14.7 3.76 3.90

10

- 304

- 3418 Crown 30.2 16.3 22.7

- 10

- 304

- 3419 Bracelet 87.8 23.7 19362 169

10

- 304

- 3420 Bracelet 90.0 34.2 3545 142

10

- 304

- 3421 Bracelet 89.9 29.7 8506 143

10

- 304

- 3422 Bracelet 89.0 25.4 3008 108

10

- 304

- 3815 Pendant 16.0 13.8

- - 10

- 304

- 3816 Pendant 15.4 6.94

- - 10

- 304

- 3817 Pendant 16.4 5.39

- - 10

- 304

- 3818 Pendant 15.6 8.97

- - 10

- 810

- 5600 Tag 29.8 8.11 16.4

- 10

- 810

- 5600 Pendant 29.9 15.5 726

- 10

- 810

- 5600 Clamp 26.0 9.17 12 .3

- 10

- 810

- 5601 Tag 27.2 16.2 45.6

- 10

- 810

- 5601 Pendant 26.0 18.5 36.5

-34 

## 3.0 SUMMARY OF METHOD

3.1 Selection of Test Materials

A brief survey of 20 metal components from 14 children’s jewelry products
(submitted to the laboratory due to expected cadmium content) found that copper and
zinc were the most prevalent metals (Figure 3). Other elements preliminarily
identified by XRF include: tin, silver, bismuth, antimony, titanium, nickel, lead, and
iron. These elements were present less frequently and at lowe r concentrations than
copper and zinc. A variety of commercially available materials was acquired for use
as standards in this study. Metal alloy and plastic standards include materials similar
to the substrates and coatings used in the jewelry products d escribed above. Study
materials contain a range of cadmium concentrations and, unlike most children’s
jewelry, the study materials are homogenous. Certificates of chemical analysis are
included in the Appendix 2



## .

A material’s surface area is expected to a ffect its soluble cadmium. In an effort to
standardize the exposed area between study alloys, materials were acquired in wire

form with diameters of 2.36

- 2.39 mm whenever possible. Plastics and some alloys

were not available with these dimensions, so extra ctions were also conducted using
powdered material. Powdered materials represent a surface area limit that is
significantly greater than what is expected for accessible areas on children’s products.

Figure 3. XRF estimates of copper and zinc content in jewelry components. Note, XRF
accuracy for copper and zinc have not been determined at CPSC. The values presented
above should be considered relative estimates only. As shown elsewhere in this

memorandum, cadmium XRF measurements for real

- world (inhomog eneous) metal
samples generally have poor accuracy.

2 Manufacturer specific information has been coded and certificates of analyses redacted pursuant to section 6 (b) of the
Consumer Product Safety Act

.35 

## 3.2 Test Material Preparation

Plastic materials and metals purchased in powder form were used without cleaning or
sanding. Metal materials received in wire, disc, or bar form were cleaned using
standard p ractices for the preparation of corrosion test specimens (Ref. 2). In brief,

the materials were each washed in hexanes, and then sanded with 600

- grit silicon
carbide abrasive paper. Sanded materials were washed thoroughly with deionized
water followed by a cetone and then dried with hot air. Powdered metal material was
made from cleaned bulk solids with a rotary grinding tool. Plastics purchased in pellet
form were ground to powder with a cryogenic mill.

3.3 Data Collection and Handling

The instrumentation and procedures described in this report are routinely used (with
adaptations as necessary) by CPSC staff and are similar to those that were used to
evaluate the migration of lead from children’s products (Ref. 3). Each of the study

materials was tested for ca dmium content by XRF and inductively coupled plasma

optical emission spectrometry (ICP

- OES), and for cadmium migration in saline and

dilute acid.

Twelve replicate measurements were made for each determination of cadmium

content and for each soluble cadmi um migration test of a reference alloy.
Measurements that were outside of plus or minus three times the replicate set’s
standard deviation were not included in calculations of cadmium content, accuracy,
and precision data. The final values include a minimu m of ten replicate
measurements. Measurement precision is illustrated in plots with error bars at plus
and minus two times the standard deviation. For plastic materials, cadmium migration
was found to be less than the method detection limits, so only six r eplicate
measurements were made. Due to the difficulties involved in quantitatively
transferring small portions of material, replicate XRF measurements were not
performed for study materials in powder or pellet form.

3.4 Cadmium Screening by Portable X

- ray F luorescence Analysis

XRF measurements were made using a Thermo NITON XL3t XRF Analyzer in either
TestAll mode or Alloy mode. Measurement duration was at least 60 seconds. XRF
detection limits were estimated for plastics and metals by taking the average of
individual detection limits from multiple non

- detect measurements. The XRF limit of
detection was 2 ppm for plastics and 48 ppm for metals. Non

- detect results (i.e., less
than the analyzer’s limit of detection) are included in tables as “nd”. Non

- detect

r esults are included in plots as half the limit of detection and are indicated with a
black square ( ■).36 

## 3.5 Soluble Cadmium Migration in Saline

Extractions were performed on 0.49

- 0.51 g portions of plastic pellets, 0.148

- 0.152 g
portions of powders, 3 cm segments of 2.4 mm diameter wires (~ 1 g), and 23 cm
segments of 0.8 mm diameter wire (~ 1 g). Samples were weighed and then placed in
a 0.9% sodium chloride (NaCl) solution with a volume equal to 50 times the sample
weight (e.g., 50 mL saline solution per gram of sample). The extraction occurred over

six hours at 37.5 oC in a shaker bath. Ex traction solutions were collected and analyzed
by ICP

- OES. Samples were diluted further and reanalyzed if cadmium values
exceeded 1.5 times the concentration of the high calibration standard. The amount of
migrated soluble cadmium was calculated by multipl ying the measured concentration
by the total dilution volume (e.g., 20 μg/mL x 50 mL = 1,000 μg).

3.6 Soluble Cadmium Migration in Dilute Acid

Extractions were performed on 0.49

- 0.51 g portions of plastic pellets, 0.148

- 0.152 g
portions of powders, 3 cm segm ents of 2.4 mm diameter wires (~ 1 g), and 23 cm
segments of 0.8 mm diameter wire (~ 1 g). Samples were weighed and then placed in
a 0.07 N HCl solution with a volume equal to 50 times the sample weight (e.g., 50
mL acid solution per gram of sample). The e xtraction occurred at 37.5 oC in a shaker
bath. For wires and plastic pellets, extraction solutions were collected at 6, 24, and 48
hours after the extraction start time (i.e., samples were placed in fresh acid solutions
at the 6 and 24 hour time points). For powders, separate sample portions were used
for each time point. Extraction solutions were collected from powders using syringe
filtration units (0.45 μm). Extraction solutions were analyzed by ICP

- OES. Samples
were diluted further and reanalyzed if ca dmium values exceeded 1.5 times the
concentration of the high calibration standard. The amount of migrated soluble
cadmium was calculated by multiplying the measured concentration by the total
dilution volume (e.g., 20 μg/mL x 50 mL = 1,000 μg). For metal wires and plastic
pellets, the 24 hour

- cumulative soluble cadmium was calculated by summing the
cadmium extracted over the initial six hours and the subsequent 18 hours. The 48

- hour value is the sum of measurements taken at the three time points.

3.7 Sample P reparation for Total Cadmium Content

Samples were digested following standard operating procedures for determining total
lead in children’s products (Ref. 3). Metals were digested by the hot block method
and plastics were digested using a microwave digest ion system.

3.8 ICP

- OES Calibration and Analysis

Calibration standards were prepared at 0.00, 0.10, 0.25, 0.50, 1.00, 5.00, 10.0 and
20.0 μg/mL by the dilution of a 1,000 μg/mL cadmium standard (SCP Science,
Champlain NY; Cat# 140

- 051

- 480). A quality control standard was prepared at 0.50
μg/mL by the dilution of a 100 μg/mL multi

- element standard (SPEX CertiPrep,

Metuchen NJ; Cat# CL

- QC

- 21). An internal standard solution of 2 μg/mL yttrium in37 

## 2% nitric acid was prepared using a 1,000 μg/mL standard (SPEX Cert iPrep,

Metuchen NJ; Cat# PLY2

- 2Y). Standards, blanks, and samples were analyzed on a

Varian VISTA

- MPX CCD Simultaneous ICP

- OES system (plasma flow: 15.0 L/min;
nebulizer flow: 0.75 L/min; pump speed: 20 rpm; auxiliary gas flow: 1.5 L/min;
cadmium wavelengt h: 214.439 nm; yttrium wavelength: 324.228 nm; power: 1.20
kW; and replicates: 3). The 0

- 20 μg/mL calibration curves had correlation
coefficients greater than 0.9990 with less than 5% error for the quality control
standard. Samples with on

- instrument conce ntrations less than 5 μg/mL were
measured using a calibration range of 0

- 5 μg/mL. All other samples were evaluated
against the full calibration range.

ICP

- OES instrument detection limits were determined for each method by
multiplying three times the stan dard deviation of seven replicate measurements of
reagent blanks. Method detection limits for ICP

- OES were determined using reagent

blanks fortified with 2

- 3 times the instrument detection limits. The method detection

limits were calculated as follows: MDL = t x S, t=3.14 (99% confidence level for 7
replicates), S = standard deviation. The instrument and method detection limits are

included in Table 2 . Non

- detection ICP

- OES measurements (i.e., less than the method
detection limit) are listed in tables as “n d”. Non

- detect results are included in plots
using estimated ICP values equal to half of the method detection limit. Non

- detect
data points are indicated in plots with a black square ( ■).

Table 2 . Instrument and Method Detection Limits for ICP

- OES

Method Instrument Detection

Limit ( μ g/mL) Method Detection Limit

( μ g/mL)

Cadmium Content in Plastic 0.00 5 0.009

Total Cadmium in Metal 0.0 10 0.042

Acid Extraction of Cadmium 0.00 1 0.04 5

Saline Extraction of Cadmium 0.00 1 0.00138 

## 4.0 RESULTS AND DISCUSSION

4.1 Cha racterization of Materials and Analytical Techniques

Figure 4 compares XRF and ICP

- OES measurements for cadmium content in jewelry
samples tested at CPSC (data included in Table 1). XRF measurements for cadmium
in jewelry have significantly greater error than what is seen with homogenous alloys
(Figure 5

- C). In general, the relative error was found to increase with cadmium
content (Panel 4

- B). Figures 5

- A and B demonstrate agreement between manufacturer
certificates of analysis for metals and cadmium conte nt measurements made at CPSC
by ICP

- OES and XRF. Panel 5

- C shows good correlation between ICP

- OES and
XRF. Figure 6

- A shows moderate agreement between vendor

- certified cadmium

levels and ICP

- OES measurements for plastic test materials. Panels 6

- B and C

ind icate that XRF readings did not agree very well with either the certificates of
analysis or ICP

- OES measurements. XRF measurements of cadmium in polyvinyl
chloride standards were significantly lower than expected.

Precision and accuracy information for cadmium measurements are included in
Tables 3 and 4 for metals and plastics, respectively. Accuracy was evaluated with
comparisons of XRF and ICP

- OES cadmium content measurements to vendor

certified values (also see Figures 5 and 6). The precision of repli cate measurements

was determined as the relative standard deviation for each material available in wire
or pellet form. Relatively good accuracy and precision was obtained with ICP

- OES
for most alloy materials. The precision of XRF readings for alloys was also good but
the accuracy was off by more than 5% for half of the metals. While the accuracy and
precision of ICP

- OES analysis for plastic materials was acceptable, XRF
measurements could be classified as having moderate to poor accuracy.39 

## Figure 4

. Effect of coatings on XRF accuracy (compare with Figure 5
for homogenous materials). Panel A: XRF and ICP

- OES cadmium
measurements for jewelry components. Panel B: Relative error of XRF
measurements compared to ICP

- OES measurements (relative error =

- ( XRF concentration

- ICP concentration)/ICP concentration x 100).40 

## Figure 5

. Confirmation of vendor

- certified cadmium levels in metal test
materials by ICP

- OES (Panel A) and XRF (Panel B) analysis. Panel C
shows a linear relationship between ICP

- OES a nd XRF measurements.
Note: plots contain XRF measurements for both wires and powders.41 

## Figure 6

. Confirmation of vendor

- certified cadmium levels in plastic test
materials by ICP

- OES (Panel A). Panels B and C show XRF readings are
low compared to certif icates of analysis and ICP measurements. Note:
plots contain XRF measurements for both pellets and powders.42 

## Table 3

. Analysis of Cadmium Content in Metal Test Materials.

ICP

- OES XRF

Material Certificate
of Analysis
( % ) Mean
( % ) Standard

Deviation
( % ) RS D
(%) Recovery
(%) * Mean
( % ) Standard

Deviation

( % ) ** RSD
(%) ** Recovery
(%) *

M001 Wire 32.398 30.601 1.213 4.0 94 32.45 6 0.047 0.1 100

M001 Powder 32.398

- - - - 32.87 5

- - 101

M002 Wire 59.92 59.99 1.09 1.8 100 60.2 7 2.27 3.8 100

M002 Powder 59.92

- - - - 57.33

- - 96

M003 Wire 19.042 19.32 2 0.382 2.0 101 20.588 0.50 7 2.5 108

M003 Powder 19.042

- - - - 19.37 8

- - 102

SRM 629 Powder 0.0155 0.0185 0.0028 15.1 119 nd***

- - N/A

SRM 683 Powder 0.00011 nd N/A N/A N/A nd

- - N/A

SRM 1129 Powder 0.006 0.00 6 0.000 0.9 100 nd

- - N/A

M004 Wire 14.42 14.44 0. 10 0.7 100 13.36 0.18 1.4 93

M004 Powder 14.42

- - - - 13.54

- - 94

M005 Wire 18.22 19. 30 0.2 6 1.3 106 17.0 2 0.36 2.1 93

M005 Powder 18.22

- - - - 17.28

- - 95

M006 Wire 24.01 23.6 3 0.56 2.4 98 23 .13 0.19 0.8 96

M006 Powder 24.01

- - - - 23.17

- - 96

M007 Wire 78.01 78.44 0.95 1.2 100 87.6 5 0.3 8 0.4 112

M007 Powder 78.01

- - - - 75.8 2

- - 97

M008 Wire < 0.01 0.0 2 0.00 3.9 N/A nd

- - N/A

M008 Powder < 0.01

- - - - nd

- - N/A

M009 Powder 31.0 3 0.8 0.4 0 1.3 99 29. 2

- - 94

M010Powder 1.75 1.7 3 0.02 1.3 99 1. 90

- - 108

M011Powder 4.99 5. 02 0.04 0.9 101 4.10

- - 82

M012 Powder 0.33 0.3 4 0.00 0.7 103 0.35

- - 107

M013 Powder 0.37 0.3 8 0.00 0.5 103 0.40

- - 108
* Percent recovery was calculat ed using cadmium concentrations reported in certificates of analysis.
** A single XRF measurement was taken for powders so standard deviation and relative standard deviation data are not availa ble.

*** nd = non

- detect.43 

## Table 4

. Analysis of Cadmium Con tent in Plastic Test Materials.

ICP

- OES XRF

Material Certificate
of Analysis
(ppm) Mean (ppm) Standard

Deviation

(ppm) RSD
(%) Recovery
(%)* Mean (ppm) Recovery
(%)*

PVC001 Sample 1 0 nd ** N/A N/A N/A nd N/A

PVC001 Sample 2 50 4 8 1 2.1 96 23 46

PVC0 01 Sample 3 101 100 6 6.0 99 50 50

PE001 Sample 1 0 nd N/A N/A N/A nd N/A

PE001 Sample 2 5 0 47 0.5 1.1 94 44 88

PE001 Sample 3 1 00 100 2 1.8 100 85 85

ERM

- EC680k Pellet 19.6 17.9 1.7 9.5 91 18 92

ERM

- EC68 0 k Powder 19.6 17.9

- - - 17 87

ERM

- EC68 1 k Pel let 137 12 5 24 19 91 130 95

ERM

- EC68 1 k Powder 137 12 5

- - - 112 82
* Percent recovery was calculated using cadmium concentrations reported in certificates of analysis.

** nd = non

- detect.44 

## 4.2 Soluble Cadmium Migration

Tables 5 and 6 include data fo r soluble cadmium migration from metals into dilute
acid and saline, respectively. All measurements of soluble cadmium migration from
plastics were less than the method detection limits. Figures 7 and 8 illustrate the
migration of cadmium over time from me tal wires and powder s , respectively.
Substantially different behavior is seen for the materials, including comparisons
between alloys. Interestingly, the amount of migrated cadmium decreased over time
for some powdered alloys. This effect was not observed for any of the samples in
wire form. The decrease in migrated cadmium over time seems to be more prevalent
in powders containing high levels of zinc (32

- 93%), with the exception of NIST SRM
1129 which contains only 0.006% cadmium and no documented zinc. Th e observed
effect could come from differences in the test procedures for wire and powder
samples. For wires, extract solutions were removed at each time point and the
samples were placed in fresh solution. Extract solutions were not filtered prior to
analy sis. The cumulative soluble migrated cadmium for the 24

- hour time point is the

sum of measurements from the initial 6

- hour extraction and subsequent 18

- hour

extraction. The 48

- hour value is the sum of measurements from all three time points.
For powders, d ifferent sets of materials were used for each time point (i.e., test
materials remained exposed to extract solutions for full 6, 24, and 48

- hour periods).
Extract solutions were filtered away from powder samples using 0.45 μ m syringe

filter units. Filtrati on may have removed suspended cadmium precipitates.

No soluble cadmium was detected in saline or acid extract solutions for plastic study
materials. The plastics contained low cadmium concentrations compared to most of
the metals examined in the study. Pl astic standards with high cadmium content were
not commercially available. The plastic cadmium content levels are comparable to
those in the NIST alloy materials and M008. It may be worthwhile to survey

cadmium

- containing plastic products to ensure that ca dmium content and migration
data from study plastics are representative of real

- world products.

Figures 9

- A and B show the amount of cadmium leached from metal wires and
powders containing different levels of cadmium after 48 hours of exposure to dilute
acid. Migrated cadmium was not proportional to cadmium content. This suggests that
alloy composition and/or other material properties play a role in accessible cadmium.
Figures 10

- A and B show measurements of cadmium leached from metal wires and
powders u sing a saline solution. In general, materials that produce elevated levels of
migrated cadmium in saline also produce elevated levels in dilute acid (Figure 11).

Figure 12 illustrates the apparent effect of zinc on soluble cadmium migration from
alloys. P lotting levels of migrated cadmium against the concentration of elements
present in many of the test materials indicates an apparent trend with respect to zinc
content. Panel A shows that cadmium migration into dilute acid decreased rapidly as

zinc content increased, regardless of cadmium content. Panels B and C separate alloy
powders into groups based on elemental composition. Materials high in zinc had
relatively low migrated cadmium. Alloy materials with intermediate levels of zinc45 

## plus intermediate leve ls of silver and copper were found to produce moderate levels
of migrated cadmium compared to materials with little or no zinc.

As seen in Figures 1, 2, 9, and 10, soluble cadmium migration is not proportional to

total cadmium content. This is due to var iable composition and the presence of
coatings (e.g., paint, electroplating) on many commercial products. Since surface
properties are important factors in both XRF measurements and soluble cadmium
migration, plots were made to look for a relationship betw een the two parameters. A
linear correlation would be useful for predicting cadmium exposure risk using only
the XRF data collected in the field. However, as seen in Figure 13, the overall data
pattern is much like that in Figures 1 and 2, with cadmium con centrations shifted to
lower values. This result is not unexpected when one considers the moderately good
correlation seen in Figure 4

- A and the relative error shown in Figure 4

- B.46 

## Table 5

. Migration of Soluble Cadmium from Metals into 0.07N Hydro chloric Acid.
6h Migrated Cadmium 24h Migrated Cadmium 48h Migrated Cadmium

Material Mean
( μ g/g ) Standard

Deviation

( μ g/g ) %RSD Mean
( μ g/g ) Standard

Deviation

( μ g/g ) %RSD Mean
( μ g/g ) Standard

Deviation

( μ g/g ) %RSD

M001 Wire 1449.8 101.46 7.00 5148. 8 542 .91 10.54 9944.6 1215. 3 12.22

M001 Powder 1779 1 7754.8 43.59 47789 16538 34.61 59997 21940 36.57

M002 Wire n d * N/A N/A n d N/A N/A n d N/A N/A

M002 Powder 2807. 4 2638. 2 93.97 785.91 1316.0 167.45 76.25 128.01 167.90

M003 Wire n d N/A N/A n d N/A N/A n d N/A N/A

M003 Powder 57.94 22.76 39.29 44.63 36.46 81.70 25.30 13.16 52.02

SRM 629 Powder n d N/A N/A n d N/A N/A n d N/A N/A

SRM 683 Powder n d N/A N/A n d N/A N/A n d N/A N/A

SRM 1129 Powder 24.51 0.53 2.18 23.64 5.12 21.65 24.68 0.22 0.91

M004 Wire 86.35 7.9 2 9.18 319.73 39.29 12.29 753.13 77.69 10.32

M004 Powder 1712.4 78.09 4.56 3065. 1 324.65 10.59 3302.1 366.95 11.11

M005 Wire 25.59 2.18 8.53 84.54 4.82 5.71 160.79 7.42 4.62

M005 Powder 1267. 1 119.27 9.41 2156.7 203.58 9.44 3311.0 263.29 7.95

M006 Wire 52.31 5.69 10.87 136.54 13.43 9.84 231.70 19.52 8.43

M006 Powder 1772.2 199.64 11.27 4481.4 217.03 4.84 7474. 4 213.07 2.85

M007 Wire 1137.5 35.34 3.11 3493.2 195.60 5.60 526 9.0 364.17 6.91

M007 Powder 13695 1964. 8 14.35 1240 7 285 2

. 0 22.99 1717 6 4487. 4 26.13

M008 Wire n d N/A N/A n d N/A N/A nd N/A N/A

M008 Powder 4.26 1.43 33.49 9.21 3.12 33.89 11.76 2.70 22.94

M009 Powder 606.09 130.99 21.61 425.95 80.48 18.89 469.76 149.78 31.88

M010Powder 8457. 5 339.22 4.01 9669.4 184.08 1.90 9721.2 381.83 3.93

M0 11Powder 1593. 2 451.52 28.34 3509.3 646.65 18.43 4859.4 1016.3 20.91

M012 Powder 532.58 82.08 15.41 1059.0 59.17 5.59 1355.2 54.35 4.01

M013 Powder 674.82 50.90 7.54 1326.1 82.04 6.19 1844.9 56.99 3.09

* nd = non

- detect.47 

## Table 6

. Migr ation of Soluble Cadmium from Metals into 0.9% Saline.
6h Migrated Cadmium

Metal

Material Mean
( μ g/g ) Standard

Deviation

( μ g/g ) %RSD

M001 Wire 55.21 4.40 7.96

M001 Powder 286.70 60.75 21.19

M002 Wire nd * N/A N/A

M002 Powder 64.30 18.12 28.17

M003 Wi re nd N/A N/A

M003 Powder 59.29 17.53 29.57

SRM 629 Powder nd N/A N/A

SRM 683 Powder nd N/A N/A

SRM 1129 Powder 3.42 0.30 8.76

M004 Wire 25.47 1.92 7.53

M005 Powder 140.91 20.71 14.70

M006 Wire 4.08 1.20 29.44

M006 Powder 152.93 23.05 15.07

M007 W ire 168.83 23.44 13.88

M007 Powder 165.81 23.54 14.20

M008 Wire nd N/A N/A

M008 Powder 0.59 0.56 94.97

M009 Powder 63.12 12.92 20.48

M010Powder 284.74 15.98 5.61

M011Powder 128.89 32.33 25.09

M012 Powder 11.28 1.31 11.59

M013 Powder 6.44 1.33 20.60

* nd=non

- detect.48 

## Time (hours)

Figure 7 . Cummulative cadmium migration from wires over 6, 24, and 48 hours.
Measurements taken at the 24 and 48 hour timepoints were summed with values from
previous timepoints.Soluble Cadmium Migration (μg Cd/g Wire)



## Time (Hours)49 

## Figure 8 . Cadmium migrati on from metal powder after 6, 24, and 48 hours. Each
point is from a unique set of powders (i.e. values are not cummulative as with wires).50 

## Figure 8 (Continued) . Cadmium migration from metal powder after 6, 24, and 48
hours. Each point is from a unique set of powders (i.e. values are not cummulative as
with wires).51 

## Figure 9

. Cadmium leached from metal wires (Panel A) and powders
(Panel B) containing different levels of cadmium after 48 hours of
exposure to 0.07N HCl.52 

## Figure 10

. Cadmium leac hed from metal wires (Panel A) and powders
(Panel B) containing different levels of cadmium after 6 hours of exposure

to 0.9% NaCl.53 

## Figure 11

. Comparisons of cadmium migration from alloys into dilute

acid and saline over 6 hours. Panel A includes stu dy wires and Panel B
includes powder.54 

### (< 0.01) (30.8) (0.02) (< 0.01) (78.4)

(23.6)
(19.3) (14.4)

(19.3) (60.0)

Figure 12. Effect of zinc on cadmium migration from alloy powders. Panel A:
Cadmium migration into dilute acid (48h) as a function of zinc content. Cadmium
content (%) is in parentheses. Panel B: Effect of alloy composition on 48h cadmium
migration into dilute acid (

- ●

- : 16

- 33% Zn with 5

- 67% Cu and/or Ag;

- ♦

- : 32

- 93% Zn

with ≤1.5% Cu and Ag). Panel C: Effect of alloy composition on cadmium migration

into saline.55 

## Fig ure 13

. Soluble migrated c admium from jewelry compared to cadmium
content measurements by XRF. Panel A: Cadmium migrated into 0.07N HCl
over 24 hours. Panel B: Cadmium migrated into 0.9% NaCl over 6 hours.

5.0 CONCLUSIONS

The primary goal of this study was to characterize the migration of cadmium from a variety
of metal and plastic materials. The study found that soluble cadmium migration is not
generally proportional to cadmium content. For alloys, product composition factors such as

element content and coa tings have a larger effect on cadmium migration than does total
cadmium content. The presence of zinc reduces cadmium migration, and the addition of co

alloyed elements such as silver and copper, seems to mitigate zinc’s effect

. No detectable

cadmium was f ound to migrate from plastic materials.56 

## Efforts to define regulatory limits of total cadmium concentration based on cadmium
migration tests may be complicated by coatings and the alloy effects associated with zinc.

While one cadmium

- containing metal (eith er as a coating or coating

- free material) can
have high cadmium migration, another metal with similar cadmium content may not yield
hazardous levels of soluble cadmium for a variety of reasons (e.g., elemental content,
coating type, coating thickness).

A secondary goal of this study was to provide accuracy and precision information for
cadmium tests performed at CPSC. This information may be useful when adjusting field

XRF sample referral levels for products that require laboratory analysis. While agreemen t

between XRF and ICP

- OES cadmium content measurements for homogenous alloy
materials was good (Figure 5

- C), the relative error for XRF measurements in real

- world

( in homogeneous) samples (Figure 4) ranged from

- 1 to

- 80%. As seen in Figure 4

- A, a

cadmium X RF reading of 20% could relate to a 30

- 85% total cadmium measurement by

ICP

- OES. This error can be attributed to the common use of coatings (e.g., paint,
electroplating). No linear relationship was observed between XRF cadmium measurements
and cadmium migr ation from jewelry samples. For these reasons, plus the apparent effect
of zinc content on cadmium accessibility, the development of efficient concentration

- based
referral limits would be difficult. Even jewelry with relatively low XRF readings for

cadmium can yield relatively high levels of soluble migrated cadmium (Figure 13).

6.0 R EFERENCES

1. a) United States Consumer Product Safety Commission. “ FAF Inc. Recalls Children's
Necklaces Sold Exclusively at Walmart Stores Due to High Levels of Cadmium ,”
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10127.html , 2010; b) United States
Consumer Product Safety Commission. “ CPSC Issues Warning on Children’s Winter
and Holiday

- Themed Charm Bracelets wi th High Levels of Cadmium ,”
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10162.html , 2010; c) United States
Consumer Product Safety Commission. “ Claire's Recalls Children's Metal Charm

B racelets Due to High Levels of Cadmium ,”
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10227.html , 2010.

2. a) “Standard Practice for Preparing, Cleaning, and Evaluating Corrosion Test
Speci mens,” ASTM G 1

– 90

, American Society for Testing and Materials, 1999; b)
“Standard Guide for Conducting Corrosion Tests in Field Applications,” ASTM G 4

– 01

, American Society for Testing and Materials, 2008.

3. a) United States Consumer Product Safety Comm ission. “Standard Operating
Procedure for Determining Total Lead (Pb) in Children’s Metal Products (Including
Children’s Metal Jewelry),” http://www.cpsc.gov/about/cpsia/CPSC

- CH

- E1001

- 08.pdf,
2008; b) United States Consumer Product Safety Commission. “Stan dard Operating
Procedure for Determining Total Lead (Pb) in Non

- Metal Children’s Products,”
http://www.cpsc.gov/about/cpsia/CPSC

- CH

- E1002

- 08.pdf, 2009; c) United States
Consumer Product Safety Commission. “Standard Operating Procedure for
Determining Lead (Pb) and Its Availability in Children’s Metal Jewelry,”
http://www.cpsc.gov/businfo/pbjeweltest.pdf , 2005.57 

## APPENDIX

Certificates of Analysis5859606162