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Study name | Short Description | Data Owner |
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Phys-Chem | Appearance/physical state/colour | Robust Study Summary -- Title: Fluorine Compounds Inorganic | Author: Aigueperse J. et al. | Year: 2002 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Phys-Chem | Melting point/freezing point | Robust Study Summary -- Title: Fluorine Compounds Inorganic | Author: Aigueperse J. et al. | Year: 2002 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Phys-Chem | Density | Robust Study Summary -- Title: Fluorine Compounds Inorganic | Author: Aigueperse J. et al. | Year: 2002 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Phys-Chem | Water solubility | Robust Study Summary -- Title: Na3AlF6 (cryolite): Determination of water solubility including effect of pH | Author: Safepharm Laboratories Ltd. | Year: 2008 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Phys-Chem | Water solubility | Right to refer to study -- Title: Na3AlF6 (cryolite): Determination of water solubility including effect of pH | Author: Safepharm Laboratories Ltd. | Year: 2008 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Phys-Chem | Water solubility | Robust Study Summary -- Title: Fluorine Compounds Inorganic | Author: Aigueperse J. et al. | Year: 2002 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Particle size distribution (Granulometry)/Fibre length and diameter distribution | Robust Study Summary -- Title: Na3AlF6 ( Kryolith synth. ) HELOS (H2068) & RODOS R2: 0.25/0.45...87.5µm | Author: Solvay Fluor GmbH | Year: 2009 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Phys-Chem | Particle size distribution (Granulometry)/Fibre length and diameter distribution | Right to refer to study -- Title: Na3AlF6 ( Kryolith synth. ) HELOS (H2068) & RODOS R2: 0.25/0.45...87.5µm | Author: Solvay Fluor GmbH | Year: 2009 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Toxicological | Skin irritation / corrosion | Robust Study Summary -- Title: Primary dermal irritation of Kryocide | Author: Raltech Scientific Services | Year: 1981 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: N. | - |
Toxicological | Skin irritation / corrosion | Right to refer to study -- Title: Primary dermal irritation of Kryocide | Author: Raltech Scientific Services | Year: 1981 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: N. | - |
Toxicological | Skin irritation / corrosion | Robust Study Summary -- Title: Assessment of contact hypersensitivity to cryolite in the albino guinea pig (maximisation pig) | Author: NOTOX | Year: 1998 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study | GLP: Y. | - |
Toxicological | Skin irritation / corrosion | Right to refer to study -- Title: Assessment of contact hypersensitivity to cryolite in the albino guinea pig (maximisation pig) | Author: NOTOX | Year: 1998 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study | GLP: Y. | - |
Toxicological | Eye irritation | Robust Study Summary -- Title: Primary eye irritation of Kryocide | Author: Raltech Scientific Services | Year: 1981 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: N. | - |
Toxicological | Eye irritation | Right to refer to study -- Title: Primary eye irritation of Kryocide | Author: Raltech Scientific Services | Year: 1981 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: N. | - |
Toxicological | Skin sensitisation | Robust Study Summary -- Title: Assessment of contact hypersensitivity to cryolite in the albino guinea pig (maximisation pig) | Author: NOTOX | Year: 1998 | Guideline: 406 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Skin sensitisation | Right to refer to study -- Title: Assessment of contact hypersensitivity to cryolite in the albino guinea pig (maximisation pig) | Author: NOTOX | Year: 1998 | Guideline: 406 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | in vitro gene mutation study in mammalian cells | Robust Study Summary -- Title: Rat hepatocyte primary culture/DNA repair test on Kryocide | Author: Pharmakon Research International Inc. | Year: 1991 | Guideline: 482 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | in vitro gene mutation study in mammalian cells | Right to refer to study -- Title: Rat hepatocyte primary culture/DNA repair test on Kryocide | Author: Pharmakon Research International Inc. | Year: 1991 | Guideline: 482 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | in vitro cytogenicity study in mammalian cells (CA) | Robust Study Summary -- Title: In vitro chromosome aberration analysis of Kryocide in human lymphocytes | Author: Pharmakon Research International Inc. | Year: 1991 | Guideline: 473 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | in vitro cytogenicity study in mammalian cells (CA) | Right to refer to study -- Title: In vitro chromosome aberration analysis of Kryocide in human lymphocytes | Author: Pharmakon Research International Inc. | Year: 1991 | Guideline: 473 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Acute toxicity: oral | Robust Study Summary -- Title: Acute oral toxicity study in rats treated with the test article Criolite Sintetica | Author: RBM | Year: 1990 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Acute toxicity: oral | Right to refer to study -- Title: Acute oral toxicity study in rats treated with the test article Criolite Sintetica | Author: RBM | Year: 1990 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Acute toxicity: dermal | Robust Study Summary -- Title: Revised Report Acute Dermal Toxicity Study Kryocide Insecticide (N.B. 84-146-2B) | Author: Elars Bioresearch Laboratories Inc. | Year: 1981 | Guideline: 402 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Acute toxicity: dermal | Right to refer to study -- Title: Revised Report Acute Dermal Toxicity Study Kryocide Insecticide (N.B. 84-146-2B) | Author: Elars Bioresearch Laboratories Inc. | Year: 1981 | Guideline: 402 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Basic toxicokinetics | Robust Study Summary -- Title: Retention of fluoride from diets containing materials produced during aluminium smelting. | Author: Wright and Thompson | Year: 1978 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Toxicological | Repeated dose toxicity: oral | Robust Study Summary -- Title: Subchronic Toxicity Study with Kryocide Insecticid in Rats | Author: Weltman R. | Year: 1996 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Repeated dose toxicity: oral | Robust Study Summary -- Title: 90-Day Dietary Study in Dogs with Kryocide | Author: Hagen C. and Strouse J. | Year: 1996 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Repeated dose toxicity: oral | Robust Study Summary -- Title: The comparative toxicity of fluorine in calcium fluoride and in cryolite | Author: University of Illinois | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Developmental toxicity/teratogenicity | Robust Study Summary -- Title: A developmental toxicity study of Kryocide in mice | Author: WIL Research Laboratories | Year: 1991 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Developmental toxicity/teratogenicity | Right to refer to study -- Title: A developmental toxicity study of Kryocide in mice | Author: WIL Research Laboratories | Year: 1991 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Toxicity to reproduction | Robust Study Summary -- Title: A two-generation dietary reproduction study in rats with Kryocide (cryolite) | Author: Pharmaco LSR Inc. | Year: 1994 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Toxicological | Toxicity to reproduction | Right to refer to study -- Title: A two-generation dietary reproduction study in rats with Kryocide (cryolite) | Author: Pharmaco LSR Inc. | Year: 1994 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Eco-Tox | Short-term toxicity to fish | Robust Study Summary -- Title: The toxicity of cryolite to Zebra fish (Brachydanio rerio) | Author: Solvay | Year: 2008 | Guideline: 203 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Eco-Tox | Short-term toxicity to fish | Right to refer to study -- Title: The toxicity of cryolite to Zebra fish (Brachydanio rerio) | Author: Solvay | Year: 2008 | Guideline: 203 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Eco-Tox | Short-term toxicity to aquatic invertebrates | Robust Study Summary -- Title: Daphnientest akute Toxizität | Author: IWL | Year: 1998 | Guideline: 202 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Eco-Tox | Short-term toxicity to aquatic invertebrates | Right to refer to study -- Title: Daphnientest akute Toxizität | Author: IWL | Year: 1998 | Guideline: 202 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Eco-Tox | Toxicity to aquatic algae and cyanobacteria | Robust Study Summary -- Title: The toxicity of cryolite to algae (Selenastrum capricornutum) | Author: Solvay | Year: 2008 | Guideline: 201 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Eco-Tox | Toxicity to aquatic algae and cyanobacteria | Right to refer to study -- Title: The toxicity of cryolite to algae (Selenastrum capricornutum) | Author: Solvay | Year: 2008 | Guideline: 201 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | - |
Eco-Tox | Toxicity to microorganisms | Robust Study Summary -- Title: Activated sludge respiration inhibition test with cryolite | Author: Solvay | Year: 2008 | Guideline: 209 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: Y. | - |
Eco-Tox | Toxicity to microorganisms | Right to refer to study -- Title: Activated sludge, respiration inhibition test with cryolite | Author: Solvay | Year: 2008 | Guideline: 209 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: Y. | - |
Eco-Tox | Toxicity to terrestrial arthropods | Robust Study Summary -- Title: Blueberry (lowbush): Vaccinium angustifolium Aiton Blueberry flea beetle (BFB); Altica sylvia Malloch. Flea beetle control 1993. A | Author: Forsythe H.Y. Jr and Collins J.A. | Year: 1994 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Eco-Tox | Toxicity to terrestrial arthropods | Robust Study Summary -- Title: Comparative morphogenic and toxicity studies on the effect of pesticides on honeybee brood | Author: Atkins E.L. and Kellum D. | Year: 1986 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Eco-Tox | Toxicity to terrestrial arthropods | Robust Study Summary -- Title: Laboratory Evaluations of Synthetic and Natural Insecticides on Beet Armyworm (Lepidoptera: Noctuidae) Damage and Survival on Lettuce | Author: Yee W.L. and Toscano N.C. | Year: 1998 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Eco-Tox | Toxicity to terrestrial arthropods | Robust Study Summary -- Title: Effect of cryolite on consumption and utilization of food by Spodoptera litura (Fabricius). . | Author: Prasad S.R. Krshinayya P.V. and Lakshmi K.l.V. | Year: 2000 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Environmental | Hydrolysis | Robust Study Summary -- Title: The Hydrolysis of Synthetic Cryolite (Kryocide Insecticide): Project No. WT-5-85. | Author: Dykeman R. | Year: 1985 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study | GLP: N. | - |
Environmental | Hydrolysis | Right to refer to study -- Title: The Hydrolysis of Synthetic Cryolite (Kryocide Insecticide): Project No. WT-5-85. | Author: Dykeman R. | Year: 1985 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study | GLP: N. | - |
Environmental | Adsorption/desorption | Robust Study Summary -- Title: The Leaching of Synthetic Cryolite (KRYOCIDE Insecticide) in Soil Columns: Project No. WT-4-85 | Author: Dykeman R. | Year: 1985 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: N. | - |
Environmental | Adsorption/desorption | Right to refer to study -- Title: The Leaching of Synthetic Cryolite (KRYOCIDE Insecticide) in Soil Columns: Project No. WT-4-85 | Author: Dykeman R. | Year: 1985 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: N. | - |
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Annex: | An attachment to this Agreement that makes integral part of the Agreement. |
Appendix: | An enclosure to an Annex. |
Effective Date: | The date upon which the last of the Parties signs this Agreement. |
EU REACH: | Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). |
Letter of Access: | A document signed by ReachCentrum (representing the Data Owner) and addressed to the Regulatory Authority allowing it to rely on the Studies for the benefit of the Grantee, in the format as set out in Annex 1. |
License: | Any reference to, and/or reliance on the Studies which the Grantee requires to make a submission to the Regulatory Authority for the purpose of compliance with Korea REACH as described under Article 2. |
Regulatory Authority: | National Institute of Environmental Research ("NIER"). |
Studies: | Study or studies listed in Annex 2, and if applicable, copy or copies of the study summaries and/or robust study summaries, and/or if applicable, chemical safety report ("CSR") as listed in Annex 2. |
Substance: | Trisodium hexafluoroaluminate [CAS 13775-53-6; EC 237-410-6]. |
Third Party: | Any party that is not a Data Owner or a Party to this Agreement. |
NAME: | Magdalena Selerowska |
TITLE: | General Manager |
DATE: | [_______________________] |
SIGNATURE: | [_______________________________________] |
NAME: | [_____________________________] |
TITLE: | [_______________________________________] |
DATE: | [_______________________] |
SIGNATURE: | [_______________________________________] |
GRANTEE: | [Grantee_Details] |
SUBSTANCE: | Trisodium hexafluoroaluminate [CAS 13775-53-6; EC 237-410-6] |
STUDIES: | as per Appendix 1. |
Signature: | _______________________________ |
Name: | _______________________________ |
Title: | ____________________________________ |
Date: | _____________ |