CLH REPORT FOR 2,3,5,6-TETRAFLUOROBENZYL (1R,3S)-3-(2,2-DICHLOROVINYL)-2,2- DIMETHYLCYCLOPROPANECARBOXYLATE; TRANSFLUTHRIN (ISO) Annex I to the CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: Transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)- 3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate EC Number: 405-060-5 (ELINCS)* CAS Number: 118712-89-3* Index Number: 607-223-00-8 * * The EU index no. and ELINCS no. refer to the 1R,trans and 1S,trans configurations, which is not in agreement with the definition of transfluthrin, which is exclusively the 1R,trans isomer. The CAS registry no. does refer to the correct isomer. Contact details for dossier submitter: Version number: 2.0 Date: October 2019 CLH REPORT FOR 2,3,5,6-TETRAFLUOROBENZYL (1R,3S)-3-(2,2-DICHLOROVINYL)-2,2- DIMETHYLCYCLOPROPANECARBOXYLATE; TRANSFLUTHRIN (ISO) CONTENTS 1 PHYSICAL HAZARDS .......................................................................................................................................... 5 1.1 EXPLOSIVES .......................................................................................................................................................... 5 1.2 FLAMMABLE GASES (INCLUDING CHEMICALLY UNSTABLE GASES) ........................................................................ 6 1.3 OXIDISING GASES .................................................................................................................................................. 6 1.4 GASES UNDER PRESSURE ....................................................................................................................................... 6 1.5 FLAMMABLE LIQUID .............................................................................................................................................. 7 1.6 FLAMMABLE SOLIDS ............................................................................................................................................. 7 1.6.1 Study 1 – flash point .................................................................................................................................... 7 1.6.2 Study 2 – melting point ............................................................................................................................... 8 1.6.3 Study 3 – flash point and auto-ignition ....................................................................................................... 9 1.7 SELF-REACTIVE SUBSTANCES .............................................................................................................................. 10 1.8 PYROPHORIC LIQUIDS .......................................................................................................................................... 10 1.9 PYROPHORIC SOLID ............................................................................................................................................. 10 1.10 SELF-HEATING SUBSTANCES ........................................................................................................................... 10 1.11 SUBSTANCES WHICH IN CONTACT WITH WATER EMIT FLAMMABLE GASES...................................................... 10 1.12 OXIDISING LIQUIDS......................................................................................................................................... 10 1.13 OXIDISING SOLIDS .......................................................................................................................................... 10 1.14 ORGANIC PEROXIDES ...................................................................................................................................... 11 1.15 CORROSIVE TO METALS .................................................................................................................................. 12 1.16 OTHER STUDIES .............................................................................................................................................. 12 2 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ........... 14 2.1.1 Study 1 - Metabolism in female rats .......................................................................................................... 14 3 HEALTH HAZARDS ........................................................................................................................................... 33 3.1 ACUTE TOXICITY - ORAL ROUTE .......................................................................................................................... 33 3.1.1 Animal data ............................................................................................................................................... 33 3.1.1.1 Study 1 - Basic Toxicokinetics in the Rat .............................................................................................................. 33 3.1.1.2 Study 2 - Acute oral toxicity in the mouse ............................................................................................................. 40 3.1.2 Human data............................................................................................................................................... 43 3.1.3 Other data ................................................................................................................................................. 43 3.2 ACUTE TOXICITY - DERMAL ROUTE ..................................................................................................................... 44 3.2.1 Animal data ............................................................................................................................................... 44 3.2.2 Human data............................................................................................................................................... 47 3.2.3 Other data ................................................................................................................................................. 47 3.3 ACUTE TOXICITY - INHALATION ROUTE ............................................................................................................... 47 3.3.1 Animal data ............................................................................................................................................... 47 3.3.2 Human data............................................................................................................................................... 50 3.3.3 Other data ................................................................................................................................................. 50 3.4 SKIN CORROSION/IRRITATION.............................................................................................................................. 50 3.4.1 Animal data ............................................................................................................................................... 50 3.4.2 Human data............................................................................................................................................... 52 3.4.3 Other data ................................................................................................................................................. 52 3.5 SERIOUS EYE DAMAGE/EYE IRRITATION .............................................................................................................. 53 3.5.1 Animal data ............................................................................................................................................... 53 3.5.2 Human data............................................................................................................................................... 55 3.5.3 Other data ................................................................................................................................................. 55 3.6 RESPIRATORY SENSITISATION ............................................................................................................................. 55 3.6.1 Animal data ............................................................................................................................................... 56 3.6.2 Human data............................................................................................................................................... 56 3.6.3 Other data ................................................................................................................................................. 56 3.7 SKIN SENSITISATION ............................................................................................................................................ 56 3.7.1 Animal data ............................................................................................................................................... 56 CLH REPORT FOR 2,3,5,6-TETRAFLUOROBENZYL (1R,3S)-3-(2,2-DICHLOROVINYL)-2,2- DIMETHYLCYCLOPROPANECARBOXYLATE; TRANSFLUTHRIN (ISO) 3.7.2 Human data............................................................................................................................................... 59 3.7.3 Other data ................................................................................................................................................. 59 3.8 GERM CELL MUTAGENICITY