RESPONSES TO COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFICATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	dipentyl phthalate (DPP)	
CAS number:	131-18-0	
EC number:	205-017-9	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Art. 57 (c)

Disclaimer: Comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

PART I: Responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
8	2013/04/18	International NGO
ChemSec, the International Chemical Secretariat
Sweden	ChemSec believes that for this substance there is also evidence of endocrine disruptive properties that would justify an inclusion on the candidate list also according to article 57f.
One source of information describing these properties, that was not included in the dossier is the following:

Hannas BR, Furr J, Lambright CS, Wilson VS, Foster PM, Gray LE Jr. 2011. Dipentyl phthalate dosing during sexual differentiation disrupts fetal testis function and postnatal development of the male Sprague-Dawley rat with greater relative potency than other phthalates. Toxicol Sci 120(1):184-193.
	The annex XV dossier and present consultations concern the identification of DPP as SVHC according to article 57(c). We welcome your comments and information on the endocrine disrupting properties. The need for identification under article 57(f) could be considered in the future and that would require a submission of another annex XV dossier.	
7	2013/04/18	International NGO
Health and Environment Alliance
Belgium	HEAL supports this substance being adopted as an SVHC, and believes DPP should also be considered for its endocrine disrupting properties as a potential 57f Svhc	The annex XV dossier and present consultations concern the identification of DPP as SVHC according to article 57(c). We welcome your comments and information on the endocrine disrupting properties. The need for identification under article 57(f) could be considered in the future and that would require a submission of another annex XV dossier.	
5	2013/04/17	National NGO
CHEM Trust
United Kingdom	We propose that the following discussion should be included and referenced to the following study, which is already included in the reference list.   
A study conducted at the US EPA laboratory has shown DPP to be eight fold more potent than DEHP in reducing fetal testosterone production and two to three times more potent in inducing development of early postnatal male reproductive malformations.   This study conclusively shows that DPP is a powerful anti-androgen that can exert adverse effects (Hannas et al.,2011).
Hannas BR, Furr J, Lambright CS, Wilson VS, Foster PM, Gray LE Jr. 2011. Dipentyl phthalate dosing during sexual differentiation disrupts fetal testis function and postnatal development of the male Sprague-Dawley rat with greater relative potency than other phthalates. Toxicol Sci 120(1):184-193.	The annex XV dossier and present consultations concern the identification of DPP as SVHC according to article 57(c). We welcome your comments and information on the endocrine disrupting properties. The need for identification under article 57(f) could be considered in the future and that would require a submission of another annex XV dossier.	
1	2013/04/12	Member State
Norway	General comment: The Norwegian CA supports that DPP should be identified as a substance of very high concern and should be included in the Candidate List based on its classification as a toxic to reproduction and also due to its potential as a substitute to the phthalates that are already  subject to authorization.	Thanks for support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2013/04/18	International NGO
Women in Europe for a Common Future
France	We recommend that Dipentyl phthalate be listed as SVHC of equivalent concern under REACH article 57 (f), based on the following study,  Dipentyl Phthalate Dosing during Sexual Differentiation Disrupts Fetal Testis Function and Postnatal Development of the Male Sprague-Dawley Rat with Greater Relative Potency than Other Phthalates”,   from Bethany R. Hannas, Johnathan Furr, Christy S. Lambright, Vickie S. Wilson,  Paul M. D. Foster, and L. Earl Gray, Jr., published in TOXICOLOGICAL SCIENCES 120(1), 184–193 (2011), doi:10.1093/toxsci/kfq386 which concludes: “Phthalate esters (PEs) constitute a large class of plasticizer compounds that are widely used for many consumer product applications. Ten or more members of the PE class of compounds are known to induce male fetal endocrine toxicity and postnatal reproductive malformations by disrupting androgen production during the sexual differentiation period of development. An early study conducted in the rat pubertal model suggested that dipentyl phthalate (DPeP) may be a more potent testicular toxicant than some more extensively studied phthalates. Regulatory agencies require dose-response and potency data to facilitate risk assessment; however, very little data are currently available for DPeP. The goal of this study was to establish a more comprehensive data set for DPeP, focusing on dose-response and potency information for fetal and postnatal male reproductive endpoints. We dosed pregnant rats on gestational day (GD) 17 or GD 14–18 and subsequently evaluated fetal testicular testosterone (T) production on GD 17.5 and GD 18, respectively. We also dosed pregnant rats on GD 8–18 and evaluated early postnatal endpoints in male offspring. Comparison of these data to data previously obtained under similar conditions for di (2-ethylhexyl) phthalate indicates that DPeP is approximately eightfold more potent in reducing fetal T production and two- to threefold more potent in inducing development of early postnatal male reproductive malformations. Additionally, fetal testicular T production was more sensitive to inhibitory effects of DPeP exposure than was gene expression of target genes involved in male reproductive development, supporting the use of this endpoint as a critical effect in the risk assessment process.”	The annex XV dossier and present consultations concern the identification of DPP as SVHC according to article 57(c). We welcome your comments and information on the endocrine disrupting properties. The need for identification under article 57(f) could be considered in the future and that would require a submission of another annex XV dossier.	
8	2013/04/18	International NGO
ChemSec, the International Chemical Secretariat
Sweden	We fully support the identification of the substance as an SVHC based on the hazardous property:
-Toxic to reproduction, classification 1B.
	Thanks for support	
6	2013/04/18	Other contributor
Alliance for Cancer Prevention
United Kingdom	We wish this chemical to be added to the SVHC candidate list due to its presence in plastics and potential consumer exposure through cosmetics. We are concerned about its endocrine disrupting properties. There is the likelyhood of considerable occupational exposure through beauty care work and low level daily exposure to consumers. 	The annex XV dossier and present consultations concern the identification of DPP as SVHC according to article 57(c). We welcome your comments and information on the endocrine disrupting properties. The need for identification under article 57(f) could be considered in the future and that would require a submission of another annex XV dossier.	
5	2013/04/17	National NGO
CHEM Trust
United Kingdom	CHEM Trust supports the inclusion of dipentyl phthalate in the REACH candidate list according to article 57 c) owing to its classification as a reprotoxic substance.  However, in addition it should also be included according to article 57 f given the antiandrogenic properties of dipentyl phthalate. This is of particular importance in view of the upcoming review on the scope of REACH article 60.3.	The annex XV dossier and present consultations concern the identification of DPP as SVHC according to article 57(c). We welcome your comments and information on the endocrine disrupting properties. The need for identification under article 57(f) could be considered in the future and that would require a submission of another annex XV dossier.	
4	2013/04/16	Member State
Belgium	Belgium supports the proposal to identify dipentyl phthalate as SVHC , based on article 57( c) of the REACH Regulation due to the classification as Repr. Cat. 1B.	Thanks for support	
3	2013/04/16	Member State
Germany	The German CA supports the identification of DPP as SVHC. 	Thanks for support	
2	2013/04/15	Member State
Sweden	The Swedish CA agrees that dipentyl phthalate, being classified as Repr. 1B, meets the criteria according to Article 57(c) in REACH and is thus eligible for identification as a substance of very high concern. 	Thanks for support	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
8	2013/04/18	International NGO
ChemSec, the International Chemical Secretariat
Sweden	In addition to the alternatives presented in the dossier, the following alternatives to phthalates (not specifically mentioned to be alternatives to dipentyl phthalate) are also available, as presented in the SUBSPORT database:
 
Alternative plasticizers for textile printing
Tributyl O-acetylcitrate
CAS No. 77-90-7 EC No. 201-067-0
(2-ethylhexyl) adipate (DEHA)
CAS No. 103-23-1 EC No. 203-090-1
Cyclohexane-1,2-dicarboxylic acid diisononyl ester (DINCH)
CAS No. 474919-59-0
Trioctyl trimellitate
CAS No. 3319-31-1
Dioctyl terephthalate
CAS No. 6422-86-2 EC No. 229-176-9
Company
The alternatives are being used by Inditex, who submitted the case story
Reference
http://www.subsport.eu/case-stories/377-en?lang=
 
Alternatives to PVC and thereby phthalates in textile printing
Polyurethane
Polyacrylate
Company
The alternatives are being used by Marks and Spencer, who provided the case story
Reference
http://www.subsport.eu/case-stories/373-en?lang=
 
Alternatives to PVC and thereby phthalates in textile printing
Dimethyl siloxane, hydrogen terminated
CAS No. 70900-21-9
Dimethyl, methyl hydrogen siloxane
CAS No. 68037-59-2
Company
These alternatives are used by G-Star, who provided the case story
Reference
http://www.subsport.eu/case-stories/371-en?lang=
 
Alternatives to PVC and thereby phthalates in textile printing
Casein acid
Company
The alternative has been developed by Benetton group and Grafco Srl
Reference
http://www.subsport.eu/case-stories/369-en?lang=
 
Alternatives for phthalates in cables
Trioctyl trimellitate
CAS No. 3319-31-1
Dioctyl terephthalate
CAS No. 6422-86-2 EC No. 229-176-9
Company
The alternatives are used by Dell, who provided the case story
Reference
http://www.subsport.eu/case-stories/304-en?lang=
 
Alternatives for phthalates in cables
Styrene-ethylene, butylene-styrene (sebs) polymer
CAS No. 66070-58-4
Polyphenylene ether (ppe)
CAS No. 25134-01-4
High impact polystyrene (hips)
CAS No. 9003-55-8
Polystyrene
CAS No. 9003-53-6 EC No. 500-008-9
Thermoplastic co-polyester; polymer with 1,4-butanediol and .alpha.-hydro-.omega.-hydroxypoly(oxy-1,4-butanediyl)
CAS No. 9078-71-1
Companies
The following suppliers of alternatives are mentioned in a case story from Hewlett Packard:
Kraton Polymers, PolyOne GS, SABIC innovative plastics, Showa Kasei Kogyo
Reference
http://www.subsport.eu/case-stories/114-en?lang=
 
Alternatives for phthalates in cables
Ethyl-vinyl-acetate, eva
CAS No. 24937-78-8
Polyethylene, PE
CAS No. 9002-88-4
Polypropylene
CAS No. 9003-07-0
Company
NKT-cables
Reference
http://www.subsport.eu/case-stories/039-en?lang=
 
Alternative to PVC and phthalates in flooring
Ethene-1-octene co-polymer
CAS No. 26221-73-8
Company
Shaw industries
Reference
http://www.subsport.eu/case-stories/155-en?lang=
 
Available alternatives for healthcare can be found in the following document
http://www.subsport.eu/case-stories/291-en?lang=
 
Available alternatives for toys can be found in the following report
http://www.subsport.eu/case-stories/026_en?lang=	We welcome this helpful info.	
5	2013/04/17	National NGO
CHEM Trust
United Kingdom	The main use seems to be the use as plasticizer in PVC. The placing of DPP on the REACH candidate list should be followed by further restrictions so that the exposure from imported articles will be addressed as well.	We agree with this comment.