Committee for Risk Assessment RAC Annex 1 Background document to the Opinion proposing harmonised classification and labelling at EU level of piperonyl butoxide (ISO); 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether EC Number: 200-076-7 CAS Number: 51-03-6 CLH-O-0000006819-59-01/F The background document is a compilation of information considered relevant by the dossier submitter or by RAC for the proposed classification. It includes the proposal of the dossier submitter and the conclusion of RAC. It is based on the official CLH report submitted to public consultation. RAC has not changed the text of this CLH report but inserted text which is specifically marked as ‘RAC evaluation’. Only the RAC text reflects the view of RAC. Adopted 11 June 2020 P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu [04.01-ML-009.02] ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON PIPERONYL BUTOXIDE (ISO); 2-(2-BUTOXYETHOXY)ETHYL 6-PROPYLPIPERONYL ETHER ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON PIPERONYL BUTOXIDE (ISO); 2-(2-BUTOXYETHOXY)ETHYL 6-PROPYLPIPERONYL ETHER CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 Substance Name: 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether; piperonyl butoxide (ISO) EC Number: 200-076-7 CAS Number: 51-03-6 Index Number: n/a Contact details for dossier submitter: General Chemical State Laboratory of Greece 16 Anastasiou Tsocha Str., 11521 Ampelokipi, Athens, Greece Tel: 0030 210 6479286, 0030 210 6479408 Fax: 0030 210 6466917 Email: [email protected] Scientific Advisor: Benaki Phytopathological Institute 8 Stefanou Delta Str., 145 61 Kifissia, Attica, Greece Tel: 0030 210 8180334 Email: [email protected] ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON PIPERONYL BUTOXIDE (ISO); 2-(2-BUTOXYETHOXY)ETHYL 6-PROPYLPIPERONYL ETHER Version number: 1.4 Date: March 2019 CONTENTS PART A. ............................................................................................................................................................................ 7 1 PROPOSAL FOR HARMONISED CLASSIFICATION AND LABELLING ................................................. 7 1.1 SUBSTANCE ........................................................................................................................................................... 7 1.2 HARMONISED CLASSIFICATION AND LABELLING PROPOSAL .................................................................................. 7 1.3 PROPOSED HARMONISED CLASSIFICATION AND LABELLING BASED ON CLP REGULATION .................................... 8 2 BACKGROUND TO THE CLH PROPOSAL ................................................................................................... 10 2.1 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING ............................................................................ 10 2.2 SHORT SUMMARY OF THE SCIENTIFIC JUSTIFICATION FOR THE CLH PROPOSAL .................................................. 10 2.3 CURRENT HARMONISED CLASSIFICATION AND LABELLING .................................................................................. 11 2.4 CURRENT SELF-CLASSIFICATION AND LABELLING ............................................................................................... 12 3 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL .............................................. 13 PART B. ........................................................................................................................................................................... 14 1 IDENTITY OF THE SUBSTANCE .................................................................................................................... 14 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCE ............................................................................................ 14 1.2 COMPOSITION OF THE SUBSTANCE ...................................................................................................................... 15 1.2.1 Composition of test material ..................................................................................................................... 16 1.3 PHYSICO-CHEMICAL PROPERTIES ........................................................................................................................ 16 2 MANUFACTURE AND USES ............................................................................................................................ 18 2.1 MANUFACTURE ................................................................................................................................................... 18 2.2 IDENTIFIED USES ................................................................................................................................................. 18 3 CLASSIFICATION FOR PHYSICO-CHEMICAL PROPERTIES ................................................................ 18 3.1 INSERT HAZARD CLASS WHEN RELEVANT AND REPEAT SECTION IF NEEDED ........................................................ 18 3.1.1 Summary and discussion of Piperonyl Butoxide ....................................................................................... 18 3.1.2 Comparison with criteria .......................................................................................................................... 18 3.1.3 Conclusions on classification and labelling ............................................................................................. 18 4 HUMAN HEALTH HAZARD ASSESSMENT .................................................................................................. 20 4.1 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ............................................. 20 4.1.1 Non-human information ............................................................................................................................ 20 4.1.2 Human information ................................................................................................................................... 23 4.1.3 Summary and discussion on Toxicokinetics .............................................................................................. 23 4.2 ACUTE TOXICITY – ORAL ROUTE ........................................................................................................................ 24 4.2.1 Short summary and overall relevance of the provided information on acute oral toxicity ....................... 24 4.2.2 Comparison with criteria .......................................................................................................................... 24 4.2.3 Conclusions on classification and labelling for acute oral toxicity .......................................................... 25 4.3 ACUTE TOXICITY – DERMAL ROUTE ................................................................................................................... 25 4.3.1 Short summary and overall relevance of the provided information on acute dermal toxicity .................. 25 4.3.2 Comparison with criteria .......................................................................................................................... 25 4.3.3 Conclusions on classification and labelling for acute dermal toxicity ..................................................... 25 4.4 ACUTE TOXICITY – INHALATION ROUTE ............................................................................................................. 26 4.4.1 Short summary and overall relevance of the provided information on acute inhalation toxicity ............. 26 4.4.2 Comparison with criteria .......................................................................................................................... 26 4.4.3 Conclusions on classification and labelling for acute inhalation toxicity ................................................ 26 4.5 SKIN CORROSION/IRRITATION ............................................................................................................................. 28 4.5.1 Short summary and overall relevance of the provided information on skin corrosion/irritation ............. 28 4.5.1.1 Non-human information ......................................................................................................................................... 28 4.5.1.2 Human information ................................................................................................................................................ 29 4 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON PIPERONYL BUTOXIDE (ISO); 2-(2-BUTOXYETHOXY)ETHYL 6-PROPYLPIPERONYL ETHER 4.5.1.3 Summary and discussion of skin irritation/corrosion ............................................................................................. 29 4.5.2 Comparison with criteria .......................................................................................................................... 29 4.5.3 Conclusions on classification and labelling for skin corrosion/irritation ................................................ 29 4.6 SERIOUS EYE DAMAGE/EYE IRRITATION .............................................................................................................. 30 4.6.1 Short summary and overall relevance of the provided information on serious eye damage/eye irritation 30 4.6.1.1 Non-human information ........................................................................................................................................