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EC number: 268-215-4 | CAS number: 68037-92-3 This substance is identified by SDA Substance Name: C16-C22 alkyl amine and SDA Reporting Number: 21-029-00.
- 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
C16-22-(even numbered)alkylamines (CAS
no 68037-92-3) has been tested for genetic toxicity in three in vitro
tests.
In the bacterial reverse mutation assay (Ames test), with reliability
rating 1, C16-22-(even numbered)alkylamines (CAS no 68037-92-3) did not
cause any significant increase in revertant colony numbers of any of the
five tested strains at any dose level, either in the presence or absence
of metabolic activation (S-9 mix). No evidence of mutagenic potential
was seen in this study.
It can be stated that in the in vitro chromosome aberration test in human lymphocytes and under the experimental conditions reported, the test item C16-22-(even numbered)alkylamines (CAS no 68037-92-3) did not induce structural and/or numerical chromosomal damage in Chinese hamster cells.
In the in vitro mammalian cell gene mutation test (HPRT-Locus) in Chinese Hamster V79 cells under the experimental conditions reported, the test item C16-22-(even numbered)alkylamines (CAS no 68037-92-3) is considered to be non-mutagenic.
Justification for selection of genetic toxicity endpoint
No specific study has been selected as the conclusion that C16-22-(even numbered)alkylamines (CAS no 68037-92-3) is not genotoxic/mutagenic is based on the three negative in vitro studies available; the Ames test (OECD 471), the chromosome aberration test (OECD 473) and the mammalian cell gene mutation test in the HPRT locus (OECD 476).
Short description of key information:
C16-22-(even numbered)alkylamines (CAS no 68037-92-3) has been tested in three in vitro genotoxicty studies.
The first study available on the substance is the bacterial reverse mutation assay (Ames test) compliant to OECD Guideline 471, performed under GLP and with reliability rating 1. In the study the bacteria strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 of S. typhimurium were exposed to the substance in the presence and absence of S9 mix. There was no evidence of induced mutant colonies over background. This study is classified as acceptable and C16-22-(even numbered)alkylamines (CAS no 68037-92-3 is considered to be non-mutagenic in this bacterial reverse mutation assay.
The second available genetic toxicity study C16-22-(even numbered)alkylamines (CAS no 68037-92-3) is the in vitro mammalian chromosome aberration test in Chinese hamster cells (OECD Guideline 473), which is GLP compliant and has reliability rating 1. In Experiment I and in Experiment II, both in absence and presence of S9 mix, concentrations showing clear cytotoxicity were seen. In both Experiment I and II with metabolic activation precipitation was seen, but not without metabolic activation. The substance is considered to be non-clastogenic in this chromosome aberration test, when tested up to cytotoxic concentrations or precipitating concentrations.
The third genetic toxicity study on the substance is the in vitro mammalian cell gene mutation test (HPRT-Locus) in Chines Hamster V79 cells (OECD 476) which is GLP compliant and have reliability rating 1. In Experiment I and in Experiment II, both in absence and presence of S9 mix, concentrations showing clear cytotoxicity were seen. In conclusion, in the described in vitro cell gene mutagenicity test under the experimental conditions reported, the test item C16-22-(even numbered)alkylamines is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the negative findings in the three available in-vitro tests for genotoxicity, C16-22-(even numbered)alkylamines (CAS no 68037-92-3) does not require classification as a mutagen according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.
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