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EC number: 271-085-1
CAS number: 68515-43-5
Non-classification justified on the basis of lack of concern in
structurally related phthalate esters that have been examined and
subjected to formal risk assessment.
Several phthalates ranging from C8-C11 have been tested for
repeat-dose toxicity in studies ranging from 21 days to two years. (Barber,
E.etal. Peroxisome induction studies on seven phthalate esters.
Toxicology and Industrial Health 3: 7-22, 1987. Butala, J.etal.
(1996). Oncogenicity study of di(isonony1)phthalate in rats. The
Toxicologist 30: 202; Lington,A.et al.Chronic toxicity and
carcinogenic evaluation of diisononyl phthalate in rats. Fundamental and
Applied Toxicology 36: 79-89, 1997;David,
R.etal. Esters of aromatic mono-, di-, and tricarboxylic acids,
aromatic diacids and di-, tri-, or polyalcohols.In:Patty's
Toxicology, Fifth edition, Vol. 6, Bingham E., B. Cohrssen and C.H.
Powell (eds.), John Wiley & Sons, Inc. pp. 635-932, 2001).The
principal effects found in these studies were those associated with
peroxisomal proliferation, including liver enlargement and induction of
peroxisomal enzymes. The strongest inducers of peroxisomal proliferation
were DEHP, DINP and DIDP with substances of shorter and longer ester
side chains (C6-C10, C7-C11 and C11) showing less pronounced effects. It
has been concluded that members of the category would show similar but
not more pronounced effects than those associated with DINP and DIDP.
The relevance of these findings to human health is regarded as
questionable as it has been shown that such effects are mediated through
the peroxisome proliferation-activated receptor alpha (PPARα); (Valles,
of PPAR alpha in response to diisononyl phthalate (DINP). The
Toxicologist 54: 418, 2000 and Ward,
and nonreceptor-mediated, organ-specific toxicity ofdi(2-ethylhexy1)phthalate(DEHP)
in peroxisome proliferator-activated receptor alpha-null mice.
Toxicologic Pathology 26: 240-246, 1998) and that levels of
PPARα are much higher in rodents than humans (Tugwood, J.etal.(1996).
Peroxisome proliferator-activated receptors: Structure and Function.
Annals of theof Sciences Vol. 804., pp. 252-265, 1996 andPalmer,
proliferator activated receptor alpha expression in human liver.
Molecular Pharmacology 53: 14-22,1998). Humans are thus
expected to be significantly less responsive than rodents to peroxisome
This is reflected in EU assessment of a number of phthalates
(Commission Communication on the results of the risk evaluation and the
risk reduction strategies for the substances: Dibutylphthalate;
3,4-Dichloroaniline; Di-isodecyl phthalate; 1,2-Benzenedicarboxylic
acid, di-C9-11-branched alkyl esters, C 10-rich; Di-isononyl phthalate;
1,2-Benzenedicarboxylic acid, di-C8-1O-branched alkyl esters, C9-rich;
Ethylenediaminetetraacetate; Methyl acetate; Monochloroacetic acid;
n-Pentane; Tetrasodium ethylenediaminetetraacetate. Official Journal of
the European Union 13th April 2006, 2006/C 90/04). The risk evaluation
activities with regard to man and the environment was conducted in
accordance with Commission Regulation (EC) No. 1488/94 of 28th June
1994. Di-isononyl phthalate (a C9 phthalate), 1,2-benzenedicarboxylic
acid, di-C8-10-branched alkyl esters, C9-rich (a C8-C10 phthalate),
di-isodecyl phthalate (a C10 phthalate) and 1,2-benzenedicarboxylic
acid, di-C9-1 1-branched alkyl esters, C 10-rich (a C9-C11 phthalate)
are all not classified and the conclusion of the assessment of the risks
to workers, consumers and man exposed via the environment was that there
is no need for further information and/or testing or for risk reduction
measures beyond those already applied. This conclusion was reached
because the risk assessments show that risks are not expected.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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