Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-200-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In an GLP/OECD Test Guideline 471 study to determine the mutagenic potential of the Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate in bacterial cells in vitro, negative results were obtained using histidine-requiring auxotroph strains of Salmonella typhimurium (TA 100, TA 98, TA 1537 and TA 1535) and using the tryptophan-requiring strain of Escherichia coli ,WP2 uvrA, in the presence and in the absence of metabolic activation (Valiczko, 2013). The substance did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used and had no mutagenic activity in the bacterial test strains used in the study. On this basis, the Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate is not genotoxic in bacterial cells in vitro.
The claustogenic potential of the substance in vitro was assessed in a chromosome aberration study conducted according to OECD Test Guideline 473 using Chinese hamster V79 lung cells (Hargitai, 2014a). In the study, three separate assays were carried out in which cells were treated with the test item at concentrations between 312.5 to 5000 μg/L with metabolic activation (in the presence of S9-mix) for 3 hours or without metabolic activation (in the absence of S9-mix) for 3 or for 20 hours. Treatment with the test item resulted in a statistically marginally significant repeatable, dose-dependent increase in the frequency of the cells with structural chromosome aberrations without gaps in the absence of a metabolic system. No increase in the aberration frequency was detected in the presence of metabolic activation system. It was concluded that the Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate was considered to be claustogenic in the test system.
The potential for the substance to cause genotoxic effects in the bone marrow erythrocytes of mice was assessed in a micronucleus test conducted according to OECD Test Guideline 474 (Hargitai, 2014b). In the study, groups of male mice were treated with the vehicle (distilled water) or the test item at 500, 1000 or 5000 mg/kg BW/day by oral gavage or the positive control item (cyclophosphamide dissolved in physiological saline) at 60 mg/kg bw administered by intraperitoneal injection. There was no treatment related effects on bodyweight, no mortalities or signs of systemic toxicity. Piloerection was seen in the high and mid dose groups. No biologically or statistically significant increases in the frequency of micronucleated polychromatic erythrocytes were seen in mice treated with the test item, compared to the negative (vehicle) control at any of the sampling time points. The positive control treatment caused a strong, clearly positive response demonstrating the sensitivity of the test system.
The Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate did not induce micronuclei in the bone marrow erythrocytes of mice treated up to 2000 mg/kg bw/day. The substance was not found to have any genotoxic activity under the conditions of the study.
Justification for selection of genetic toxicity endpoint
Negative results were obtained in an Ames tests. The substance was found to be claustogenic to Chinese hamster cells in the absence of metabolic activation in an in vitro chromosome aberration assay. However, negative results were obtained in a mouse micronucleus test indicating that the substance does not have genotoxic potential in vivo.
Short description of key information:
No evidence of mutagenicity was seen for the Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate in a bacterial reverse mutation assay (Ames test). The substance was found to be clastogenic to Chinese hamster cells in the absence of metabolic activation in an in vitro chromosome aberration assay but gave negative results in an in vivo micronucleus test conducted to assess the induction of micronuclei in the bone marrow erythrocytes of mice. The substance does not have genotoxic potential in vivo.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate is not genotoxic in bacterial cells in vitro. While the substance was found to be claustogenic in mammalian cells in vitro in a chromosome aberration study, the substance gave negative results in an in vivo micronucleus test conducted to assess the induction of micronuclei in the bone marrow erythrocytes of mice. Based on these findings, the substance does not meet the criteria for classification for genotoxicity according to Directive 67/548/EEC or Regulation 1272/2008/EC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.