HERA Hydrotropes Sept 2005 Hydrotropes... cumene sulfonates (including sodium, potassium, ammonium...

download HERA Hydrotropes Sept 2005 Hydrotropes... cumene sulfonates (including sodium, potassium, ammonium and

of 92

  • date post

    09-Apr-2020
  • Category

    Documents

  • view

    0
  • download

    0

Embed Size (px)

Transcript of HERA Hydrotropes Sept 2005 Hydrotropes... cumene sulfonates (including sodium, potassium, ammonium...

  • HERA Hydrotropes September 2005

    - 1 -

    Human & Environmental Risk Assessment

    on ingredients of household cleaning products

    Hydrotropes CAS No. NAME 12068-03-0 Toluene sulfonate, sodium salt 16106-44-8 30526-22-8 Toluene sulfonate, potassium salt

    827-21-4 1300-72-7 Xylene sulfonate, sodium salt

    30346-73-7 Xylene sulfonate, potassium salt 26447-10-9 Xylene sulfonate, ammonium salt 28088-63-3 Xylene sulfonate, calcium salt 28348-53-0 32073-22-6 Cumene sulfonate, sodium salt

    37475-88-0 Cumene sulfonate, ammonium salt

    Edition 1.0 September 2005

    All rights reserved. No part of this publication may be used, reproduced, copied, stored or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the

    HERA Substance Team or the involved company.

    The content of this document has been prepared and reviewed by experts on behalf of HERA with all possible care and from the available scientific information. It is provided for information only. Much of the original underlying data

    which has helped to develop the risk assessment is in the ownership of individual companies. HERA cannot accept any responsibility or liability and does not provide a warranty for any use or interpretation of the

    material contained in this publication

  • HERA Hydrotropes September 2005

    - 2 -

    1. Table of Contents Page No. Executive Summary ............................................................................................................................4 Substance Characterisation ................................................................................................................6

    CAS No. and grouping information .............................................................................................6 Chemical structure and composition ...........................................................................................7 Manufacturing route and production/volume statistics .............................................................9 Consumption scenario in Europe ...............................................................................................10 Use application summary ............................................................................................................10

    Environmental Assessment...............................................................................................................10 Environmental exposure assessment..........................................................................................10

    Environmental fate: biotic and abiotic degradability...........................................................11 Removal ....................................................................................................................................12 Monitoring studies ...................................................................................................................12 Exposure modelling: scenario description.............................................................................12 Substance data used for the environmental exposure calculations .....................................12 PEC calculations ......................................................................................................................13 Bioaccumulation potential.......................................................................................................14

    Environmental effects assessment ..............................................................................................14 Ecotoxicity ................................................................................................................................14

    Aquatic acute toxicity ..........................................................................................................14 Terrestrial and sediment ecotoxicity ..................................................................................16 Microbial toxicity .................................................................................................................16

    PNEC calculations ...................................................................................................................16 Aquatic PNEC ......................................................................................................................16 Terrestrial PNEC .................................................................................................................16 Freshwater sediment PNEC................................................................................................17 STP PNEC ............................................................................................................................17

    Environmental risk assessment ..................................................................................................17 Human Health Assessment..............................................................................................................18

    Consumer exposure........................................................................................................................18 Product types............................................................................................................................18 Consumer contact scenarios....................................................................................................18 Consumer exposure estimates.................................................................................................19

    Direct skin contact .................................................................................................................19 Indirect skin contact ............................................................................................................22 Exposure by inhalation........................................................................................................23 Oral exposures......................................................................................................................24 Aggregate Exposure.............................................................................................................27 Accidental or intentional overexposure .............................................................................27

    Hazard assessment .........................................................................................................................27 Summary of the available toxicological data.........................................................................27

    Toxicokinetics .......................................................................................................................28 Acute toxicity.........................................................................................................................28 Skin and eye irritation............................................................................................................28 Sensitisation ...........................................................................................................................29 Repeated dose toxicity ...........................................................................................................30 Genetic toxicity......................................................................................................................34 Carcinogenicity ....................................................................................................................35 Reproductive toxicity...........................................................................................................35 Developmental toxicity ........................................................................................................35

  • HERA Hydrotropes September 2005

    - 3 -

    Identification of critical endpoints .........................................................................................36 Overview on hazard identification.........................................................................................36 Adverse effects related to accidental exposure......................................................................37

    Determination of NOAEL or quantitative evaluation of data .............................................37 Risk assessment .............................................................................................................................38

    Margin of exposure calculations.............................................................................................38 Exposure scenario: direct skin contact...................................................................................38 Exposure scenario: Indirect skin exposure ...........................................................................39 Exposure scenario: inhalation ................................................................................................39 Exposure scenario: oral route.................................................................................................40 Aggregate exposure ...............................................................................................................40 Accidental and intentional overexposure...............................................................................41

    Risk characterization...............................................................................................................41 Systemic toxicity....