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Study name | Short Description | Data Owner |
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Phys-Chem | Appearance/physical state/colour | Robust Study Summary -- Title: Hexion Specialty Chemicals Safety Data Sheet Versatic 5 (Pivalic Acid) Version 5 | Author: Hexion Specialty Chemicals | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Appearance/physical state/colour | Right to refer to study -- Title: Hexion Specialty Chemicals Safety Data Sheet Versatic 5 (Pivalic Acid) Version 5 | Author: Hexion Specialty Chemicals | Year: No year provided | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Appearance/physical state/colour | Robust Study Summary -- Title: Hexion Specialty Chemicals Safety Data Sheet Versatic 5 (Pivalic Acid) Version 5 | Author: Hexion Specialty Chemicals | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Appearance/physical state/colour | Right to refer to study -- Title: Hexion Specialty Chemicals Safety Data Sheet Versatic 5 (Pivalic Acid) Version 5 | Author: Hexion Specialty Chemicals | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Melting point/freezing point | Robust Study Summary -- Title: MPBPWIN v1.42 | Author: U.S. Environmental Protection Agency | Year: 2000 | Guideline: 102 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Melting point/freezing point | Right to refer to study -- Title: MPBPWIN v1.42 | Author: U.S. Environmental Protection Agency | Year: 2000 | Guideline: 102 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Boiling point | Robust Study Summary -- Title: MPBPWIN v1.42 | Author: U.S. Environmental Protection Agency | Year: 2000 | Guideline: 103 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Boiling point | Right to refer to study -- Title: MPBPWIN v1.42 | Author: U.S. Environmental Protection Agency | Year: 2000 | Guideline: 103 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Vapour pressure | Robust Study Summary -- Title: MPBPWIN v1.42 | Author: U.S. Environmental Protection Agency | Year: 2000 | Guideline: 104 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Vapour pressure | Right to refer to study -- Title: MPBPWIN v1.42 | Author: U.S. Environmental Protection Agency | Year: 2000 | Guideline: 104 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Partition coefficient | Robust Study Summary -- Title: Pivalic Acid: Determination of the n-octanol/water partition coefficient using a reverse-phase HPLC method | Author: Eadsforth C.V. | Year: 1983 | Guideline: 107/117/122/123 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Phys-Chem | Partition coefficient | Right to refer to study -- Title: Pivalic Acid: Determination of the n-octanol/water partition coefficient using a reverse-phase HPLC method | Author: Eadsforth C.V. | Year: 1983 | Guideline: 107/117/122/123 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Phys-Chem | Partition coefficient | Robust Study Summary -- Title: WSKOWWIN v1.67 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 107/117/122/123 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Partition coefficient | Right to refer to study -- Title: WSKOWWIN v1.67 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 107/117/122/123 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Water solubility | Robust Study Summary -- Title: Pivalic acid: water solubility | Author: P. R. Fisk | Year: 1995 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Phys-Chem | Water solubility | Right to refer to study -- Title: Pivalic acid: water solubility | Author: P. R. Fisk | Year: 1995 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Phys-Chem | Water solubility | Robust Study Summary -- Title: WATERNT™ v1.01 | Author: US Environmental Protection Agency | Year: 2002 | Guideline: 105 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Water solubility | Right to refer to study -- Title: WATERNT™ v1.01 | Author: US Environmental Protection Agency | Year: 2002 | Guideline: 105 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Water solubility | Robust Study Summary -- Title: WSKOWWIN v1.67 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 105 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Phys-Chem | Water solubility | Right to refer to study -- Title: WSKOWWIN v1.67 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 105 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Environmental | Hydrolysis | Robust Study Summary -- Title: HYDROWIN v1.67 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 111 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Environmental | Hydrolysis | Right to refer to study -- Title: HYDROWIN v1.67 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 111 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Environmental | Biodegradation in water: screening tests | Robust Study Summary -- Title: BIOWIN v4.10 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 301 A-F | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Environmental | Biodegradation in water: screening tests | Right to refer to study -- Title: BIOWIN v4.10 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 301 A-F | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Environmental | Adsorption/desorption | Robust Study Summary -- Title: PCKOCWIN v1.66 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 106 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Environmental | Adsorption/desorption | Right to refer to study -- Title: PCKOCWIN v1.66 | Author: US Environmental Protection Agency | Year: 2000 | Guideline: 106 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Eco-Tox | Short-term toxicity to fish | Robust Study Summary -- Title: The Acute Toxicity of Pivaliv Acid to Rainbow Trout (Salmo gairdneri) and (Daphnia magna) | Author: Thorpe E. | Year: 1997 | Guideline: 203 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Eco-Tox | Short-term toxicity to fish | Right to refer to study -- Title: The Acute Toxicity of Pivaliv Acid to Rainbow Trout (Salmo gairdneri) and (Daphnia magna) | Author: Thorpe E. | Year: 1997 | Guideline: 203 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Eco-Tox | Short-term toxicity to aquatic invertebrates | Robust Study Summary -- Title: The Acute Toxicity of Pivaliv Acid to Rainbow Trout (Salmo gairdneri) and (Daphnia magna) | Author: Thorpe E. | Year: 1997 | 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: The Acute Toxicity of Pivaliv Acid to Rainbow Trout (Salmo gairdneri) and (Daphnia magna) | Author: Thorpe E. | Year: 1997 | Guideline: 202 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Eco-Tox | Toxicity to aquatic algae and cyanobacteria | Robust Study Summary -- Title: Pivalic Acid: Acute Toxicity to Selenastrum capricornutum | Author: Stephenson RR | Year: 1983 | Guideline: 201 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Eco-Tox | Toxicity to aquatic algae and cyanobacteria | Right to refer to study -- Title: Pivalic Acid: Acute Toxicity to Selenastrum capricornutum | Author: Stephenson RR | Year: 1983 | Guideline: 201 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Eco-Tox | Toxicity to microorganisms | Robust Study Summary -- Title: Pivalic Acid: Toxicity to Activated Sludge in a Respiration Inhibition Test | Author: C Bayliss | Year: 2016 | Guideline: 209 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Eco-Tox | Toxicity to microorganisms | Right to refer to study -- Title: Pivalic Acid: Toxicity to Activated Sludge in a Respiration Inhibition Test | Author: C Bayliss | Year: 2016 | Guideline: 209 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Acute toxicity: oral | Robust Study Summary -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 423 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Acute toxicity: oral | Right to refer to study -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 423 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Acute toxicity: inhalation | Robust Study Summary -- Title: Pivalic Acid: Acute Inhalation Toxicity (Nose only) Study in the Rat | Author: J Bradshaw | Year: 2016 | Guideline: 403 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Acute toxicity: inhalation | Right to refer to study -- Title: Pivalic Acid: Acute Inhalation Toxicity (Nose only) Study in the Rat | Author: J Bradshaw | Year: 2016 | Guideline: 403 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Acute toxicity: dermal | Robust Study Summary -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 403 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Acute toxicity: dermal | Right to refer to study -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 403 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Skin irritation / corrosion | Robust Study Summary -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 404 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Skin irritation / corrosion | Right to refer to study -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 404 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | - |
Toxicological | Eye irritation | Robust Study Summary -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 405 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Toxicological | Eye irritation | Right to refer to study -- Title: Toxicology of fine chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Coombs A.D. | Year: 1977 | Guideline: 405 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Toxicological | Skin sensitisation | Robust Study Summary -- Title: Toxicology of Fine Chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Combs A.D. | Year: 1977 | Guideline: 406, 429 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Toxicological | Skin sensitisation | Right to refer to study -- Title: Toxicology of Fine Chemicals: Acute toxicity skin and eye irritancy and skin sensitizing potential of pivalic acid | Author: Clark D.G. Combs A.D. | Year: 1977 | Guideline: 406, 429 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. | - |
Toxicological | Repeated dose toxicity: oral | Robust Study Summary -- Title: Pivalic acid: A 28 day oral toxicity study in rats | Author: Esdaile D.J. | Year: 1991 | Guideline: 407 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Repeated dose toxicity: oral | Right to refer to study -- Title: Pivalic acid: A 28 day oral toxicity study in rats | Author: Esdaile D.J. | Year: 1991 | Guideline: 407 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Repeated dose toxicity: oral | Robust Study Summary -- Title: Pivalic acid: OECD 408 Sub-chronic toxicity study (90-day) Oral Gavage in rats | Author: Susan Cooper | Year: 2021 | Guideline: 408 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Repeated dose toxicity: oral | Right to refer to study -- Title: Pivalic acid: OECD 408 Sub-chronic toxicity study (90-day) Oral Gavage in rats | Author: Susan Cooper | Year: 2021 | Guideline: 408 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | in vitro gene mutation study in bacteria (Ames) | Robust Study Summary -- Title: Bacterial Reverse Mutation Assay: Pivalic Acid | Author: Valentine O. Wagner III MS | Year: 2016 | Guideline: 471 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | in vitro gene mutation study in bacteria (Ames) | Right to refer to study -- Title: Bacterial Reverse Mutation Assay: Pivalic Acid | Author: Valentine O. Wagner III MS | Year: 2016 | Guideline: 471 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | in vitro gene mutation study in mammalian cells | Robust Study Summary -- Title: In Vitro Mammalian Cell Gene Mutation Test (L5178Y/TK+/- Mouse Lymphoma Assay): Pivalic Acid | Author: Aparajita Dutta MSc PhD | Year: 2016 | Guideline: 476 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | in vitro gene mutation study in mammalian cells | Right to refer to study -- Title: In Vitro Mammalian Cell Gene Mutation Test (L5178Y/TK+/- Mouse Lymphoma Assay): Pivalic Acid | Author: Aparajita Dutta MSc PhD | Year: 2016 | Guideline: 476 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Genetic toxicity in vivo | Robust Study Summary -- Title: In Vitro Mammalian Chromosomal Aberration Assay in Chinese Hamster Ovary (CHO) Cells: Pivalic Acid | Author: Shambhu Roy PhD | Year: 2016 | Guideline: 483 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
Toxicological | Genetic toxicity in vivo | Right to refer to study -- Title: In Vitro Mammalian Chromosomal Aberration Assay in Chinese Hamster Ovary (CHO) Cells: Pivalic Acid | Author: Shambhu Roy PhD | Year: 2016 | Guideline: 483 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. | - |
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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 and addressed by the Data Owner to the Regulatory Authority allowing it to refer to or rely on the Studies as described under Article 2. |
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. |
Regulatory Authority: | National Institute of Environmental Research ("NIER"). |
Studies: | Study/studies listed in Annex 2, copy/copies of the study summaries and/or robust study summaries which have been provided by the Data Owner. |
Substance: | Pivalic acid[CAS 75-98-9; EC 200-922-5]. |
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IN WITNESS WHEREOF, the undersigned Parties, by their duly authorised officers, have executed and delivered this Agreement.
For the Data Owner, ReachCentrum SA
NAME: | Magdalena Selerowska |
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DATE: | ______________ |
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For the Grantee
NAME: | ____________________________ |
TITLE: | ________________________________ |
DATE: | ______________ |
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GRANTEE: | [Grantee_Details] |
SUBSTANCE: | Pivalic acid[CAS 75-98-9; EC 200-922-5] |
STUDIES: | as per Annex 2. |
This Letter of Access does not under any circumstances authorise NIER to use, reference or rely upon the Studies listed in Annex 2 below in support of other registration applications made by third parties without written permission of the Data Owner, or for purposes other than those explicitly mentioned under this Letter of Access, including, but not limited to, any use, reference or reliance outside the framework of Korea REACH.
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represented by ReachCentrum SA
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