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EC number: 303-385-6 | CAS number: 94166-87-7
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The isolated form of the test substance was used for these studies.
A key bacterial reversion assay (Ames test) was conducted onaluminum, benzoate C16-18-fatty acids complexestogether with a micronucleus assay in human lymphocytes. In the Ames test, no significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria at any dose level, up to the maximum recommended, either with or without metabolic activation or exposure method. In the micronucleus test, Aluminum, benzoate C16-18-fatty acids complexes did not induce statistically significant increase in the frequency of cells with micronuclei in cultured human peripheral blood lymphocytes when tested up to a limit of solubility in both the absence and presence of a rat liver metabolic activation system (S-9).
In the case of both studies the results were negative, therefore aluminum, benzoate C16-18-fatty acids complexeswas considered to be non-mutagenic, non-clastogenic and non-aneugenic under the conditions of these tests.
As a consequence of the negative results in both key assays, a second mutation test was performed in accordance with Annex VII REACH regulations in a mammalian cell system namely, the mouse lymphoma assay. This test was also negative.
Justification for selection of genetic toxicity endpoint
No single study is selected as aluminum, benzoate C16-18 fatty acid complexes has been subjected to three good quality guideline studies for genotoxicity covering different genotoxicity mechanisms; an Ames in vitro reverse mutation study in bacteria, an in vitro micronucleus test for the detection of the clastogenic and aneugenic potential in human lymphocytes and a mouse lymphoma assay for the detection of mutations at the thymidine kinase locus of mammalian cells caused by base pair changes, frameshift and small deletions. All three of these tests were negative.
Short description of key information:
in vitro:
- gene mutation (bacterial reversion assay/Ames test;The method was designed to conform to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF, and to meet the requirements of the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Directive 2000/32/EC and the, EPA (TSCA) OPPTS harmonised guidelines.): Negative
- Clastogenicity and aneugenicity (micronucleus assay in human lymphocytes; The test method was designed to be compatible with, OECD Guidelines for Testing of Chemicals (2010) No 487:In Vitro Mammalian Cell Micronucleus Test. ): Negative
- Mammalian cell mutagenicity test where mouse lymphoma-TK assay detects the mutations at the thymidine kinase locus caused by base pair changes, frameshift and small deletions: Negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Classification for mutagenicity generally requires positive results from appropriate in vivo studies. Negative results from the three in vitro studies indicate that testing in vivo is not necessary. Not classified for genetic toxicity. Negative results in all studies conducted.
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