Phthalate in Schulsachen
5. What daily exposure levels to phthalates are considered safe?
Current understanding about the effects of exposure to a
specific phthalate on human health is mainly based on findings
from animal studies.
Above certain exposure levels different
phthalates do cause harmful
effects in animals. The harmful effects of a given phthalate
that occur at the lowest levels of exposure are referred to as
Phthalates banned across
in all toys and childcare articles,
and in cosmetics:
toxic effects of DEHP
that appear at the lowest exposure level relate to
reproduction. The no-observed adverse effect level
is 4.8 mg/kg body weight per day body weight per day, and
the tolerable daily intake
(TDI) is 0.05 mg/kg body
weight per day. Exposure to DEHP at the doses observed in
humans does not represent a relevant risk for the
development of cancer.
- BBP (Benzylbutyl
Studies on rats show a NOAEL for BBP of
100 mg/kg body weight per day for effects on reproductive
organs. The NOAEL for developmental effects was 20 mg/kg
body weight per day in a study and of 50 mg/kg body weight
per day in another report. The TDI for BBP is 0.5 mg/kg body
weight per day.
- DBP, sometimes
written DNBP (Di-n-butyl phthalate)
toxicity of DBP targets
the male reproductive system, with a NOAEL of 50 mg/kg body
weight per day. A study on rats showed that feeding DBP to
mothers in late pregnancy and during
lactation affected the
development of both male and female offspring. A NOAEL could
not be established, but a TDI of 0.01 mg/kg body weight per
day was derived using a high safety factor.
banned in toys and childcare products
that children could put into their mouths:
DINP is a mixture of
different chemical structures, but with similar properties.
The main toxicological
effects for DINP are changes in the liver, with a
NOAEL of 15 mg/kg body
weight per day, and a TDI
of 0.15 mg/kg body weight per day. For adverse effects on
reproduction, the NOAEL varies between 500 mg/kg body weight
per day and 622 mg/kg body weight per day.
DIDP and DINP are very similar, both in
structure and properties. There is no indication that DIDP
has any effect on the reproductive organs. Overall, a NOAEL
for effects on the liver of 15 mg/kg body weight per day
derived from a study on dogs can be considered for humans.
Although no TDI is available, exposures below 0.15 mg/kg
body weight per day are of low concern as this figure is 100
smaller than the NOAEL, which is a good margin of safety.
The results of toxicological
studies show that DNOP is very unlikely to cause adverse
However, it can have an effect on the activity of the liver
and damage the thyroid.
No TDI is available for DNOP.
Not yet evaluated in an EU
The effects of DIBP on development and
reproduction are similar to those observed for
DEHP. However, there is
no information on how these effects depend on the dose
given. Further studies are thus needed to characterise the
effects of DIBP on reproduction and derive a
TDI has not been defined.