1. Regulatory classifications of DBP, DEHP, DINP and DIDP
Length of chain
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C4-C8 phthalates
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C9-C10 phthalates
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DBP
Dibutyl-phthalate
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DEHP
Diethylexyl-phthalate
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DINPDiisononyl-phthalate
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DIDPDi-isodecyl-phthalate
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1 REACH : EU Regulation on chemicals ; CLP : EU regulation on the Classification, Labelling and Packaging of Chemical substances ; IARC International Agency on Research on Cancer
2EU definition of child care article : any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children - no age specified.:
EU Definition of "placing in the mouth" : A toy or child care article can be placed in the mouth if it can be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If it can only be licked, it is not regarded as able to be placed in the mouth. Articles which
exceed a size of 5 cm in all three dimensions cannot be placed in the mouth. If an article or part of an article in one dimension is smaller than 5 cm, it can be taken into the mouth. Inaccessible parts of an article cannot be taken into the mouth.
References : Questions and Agreed Answers Concerning the Implementation of Directive 76/769/EEC on the Restrictions to Marketing and Use of Dangerous Substances https://www.strclient.com/logon/o/operations/intranet2/1235425017/index_html
Guidance Document on the Interpretation of the concept "which can be placed in the mouth" as laid down in the Annex to the 22nd
amendment of Council Directive 76-769-EEC https://www.strclient.com/logon/o/operations/intranet2/1170186898/index_html
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1.1. Chemical classification
(CAS)
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84-74-2 |
117-81-7
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28553-12-0
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68515-48-0
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1.2. EU labeling
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Toxic; Reproductive
toxicant Category 2 Risk Phrase : R 61 (may
cause harm to the unborn child) ; Risk phrase R 62 (possible risk
of impaired fertility)
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Toxic; Reproductive toxicant category 2 ; Risk phrases : R 60
(May impair fertility) -61
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does not
require labeling
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does not require labeling
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1.3. “Mutagenicity” classification
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EU: Not classified
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EU: Not classified
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EU: Not classified
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EU: Not classified
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1.4. “Carcinogenicity” classification
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EU: Not classified
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EU: Not classified
IARC (2000) : Group 3 (cannot be
classified regarding its carcinogenicity to human)
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EU: Not classified
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EU: Not classified
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1.5. “Toxicity
for the reproduction” classification
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EU (REACH) [1]: classified as a substance “toxic to reproduction” and “Reproductive
toxicant”: “May cause harm to
the unborn child”.
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EU (CLP) : DEHP is classified as a
Category 1B with risk phrase H360 (former EU classification 2)
:”reproductive toxicant for both fertility and developmental effects”
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EU: Not classified
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EU: Not classified
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1.6. Other
regulation(s)
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EU, in toys [2] concentration of DBP, BBP and DEHP
combined cannot exceed 0.1% in toys and child care articles
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EU, REACH: use submitted to authorisation from 2013EU, in toys : concentration of
DBP, BBP and DEHP combined cannot exceed 0.1% w/w in toys and child care articles.
EU REACH: Should be notified to the
European Chemical Agency ECHA if more than 1 tonne/year is put on the
marketplace per producer/importer and present in articles above 0.1%
w/w.
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none
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none
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Related publications:
Other Tables on this publication:
Table 1. Regulatory classifications of DBP, DEHP, DINP and DIDP
Table 2. Conclusions on the risk assessments of DNBP, DEHP, DINP and DIDP
Table 3. Fate of the phthalates in the human body
Table 4. Potential adverse effects of DBP, DEHP, DINP and DIDP
Table 5. Potential environmental effects of DBP, DEHP, DINP and DIDP
Table 6. Key physico-chemical properties of DBP, DEHP, DINP and DIDP