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EC number: 210-521-7 | CAS number: 617-62-9
- 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
Performed studies
In vitro Bacterial mutagenicity (Ames Test)
2-Methylglutaric acid has been evaluated in a bacterial mutagenicity assay (OECD 471) using four strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100) and one strains of Escherichia coli (WP2PuvrA).
In the different experiments, the 2-Methylglutaric acid did not show any potential of mutagenicity with and without metabolic activation.
In vitro Clastogenic Potential:
2-Methylglutaric acid has been evaluated in a chromosome aberration test (OECD 473), with and without metabolic activation. Some positive results were observed in presence of low pH and high cytotoxicity. When 2-Methylglutaric acid was neutralized, no more cytotoxicity was observed and results were negative up to maximum tested concentrations. It is concluded that 2 -Methylglutaric acid does not present clastogenic potential with or without metabolic activation.
In vitro mammalian cell mutagenicity:
2-Methylglutaric acid was tested in the L5178Y TK +/- mouse lymphoma gene mutation assay (OECD 476) in the presence of an auxiliary metabolising system (S9). Some positive results were observed in presence of low pH and high cytotoxicity. When 2-Methylglutaric acid was neutralized, no more cytotoxicity was observed and results were negative up to the maximum tested concentrations. It is concluded that 2-Methylglutaric acid does not present mutagenic potential both in the presence and in the absence of S9-mix.
In vivo Mutagenicity
2-Methylglutaric was assessed in the in vivo micronucleus test in the mouse (OECD 474). The test substance was formulated in physiological saline water, which was used as the vehicle control. The test substance was administered orally by gavage at up to 2000 mg/kg for the male and 1750 mg/kg for the female. Not treatment related clinical signs or mortality were noted.
No biological relevant increase in the mean frequency of micronucleated polychromatic erythrocytes was observed in the bone marrow of animals treated compared to the vehicle treated animals.
It is concluded that 2-Methylglutaric acid is not clastogenic or aneugenic in the bone marrow micronucleus test when sampled at 24 and 48 hours post dosing of male and female mice up to a dose of 2000 and 1750 mg/kg, respectively (maximum recommended/tolerated dose in accordance with current regulatory guidelines in males and females, respectively)
Discussion
While Ames test was clearly negative, some positive results were observed in in vitro chromosome aberration test (OECD 473) and mouse lymphoma gene mutation assay (OECD 476) but only with low pH (around 6) and in presence of strong cytotoxicity, moreover in both case, maximum test concentration was limited by cytotoxicity. In order to determine if these positive results were linked to pH, positives conditions have been re-tested with previously neutralized 2-Methylglutaric acid. In both test, neutralization suppressed cytotoxicity allowing to test the substance up to the maximum recommended dose in the guidelines (i.e. 0.01M). Neutralized 2-Methylglutaric acid induced no positive response in chromosome aberration test (OECD 473) and mouse lymphoma gene mutation assay (OECD 476). It is therefore concluded that the observed positive responses were artefacts caused by low pH. This conclusion is supported by the negative response obtained in the in vivo micronucleus test in the mouse (OECD 474) performed with 2-Methylglutaric acid.
Justification for selection of genetic toxicity endpoint
Three in vitro and one in vivo genotoxicity studies are considered to be key studies covering the mutagenic and clastogenic endpoints of genotoxicity.
Short description of key information:
The four performed GLP studies did not suggest any genotoxicity potential for the 2-Methyglutaric acid.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on absence of mutagenicity in the in vitro and in vivo tests, it is concluded that 2-Methylglutaric acid is not genotoxic. Therefore no classification is required according to the EU legislation (Directive 67/548/EEC and CLP regulation 1272/2008).
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