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Diss Factsheets
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EC number: 947-548-5 | 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In the dose-finding test and the two main tests, there was neither increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group nor dose-response for any strains irrespective of the presence/absence of metabolic activation. In conclusion, COCAMIDE DIPA was judged to have no gene mutation inducibility (negative) under the conditions of this study.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Standards Established by the Minister of Labour in Accordance with the Industrial Safety and Health Law, Article 57-4-1”, (Notification No. 208, April 18, 2016 Ministry of Labour, Japan)
Guidelines for Toxicity Testing of New Chemical Articles”, (Notification 1221 No. 1 of Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, 20151209 No. 1 of the Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, & No. 1512211 of Environmental Policy Bureau, Ministry of the Environment, Japan, on December 21, 2015) - Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Supplier: MIC Trading Co., Ltd.
Amount Received: About 10 g
Date of Receipt: April 19, 2017
Name: Coconut diisopropanolamide
Another Name: COCAMIDE DIPA
CAS Number: 68855-69-6
Lot Number: 55780B17 - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Vehicle / solvent:
- Name: 1,4-dioxane
Manufacturer: Wako Pure Chemical Industries, Ltd.
Lot Number: DSH1946
Specification: JIS Reagent Special Grade, 99.5% or more - Untreated negative controls:
- yes
- Remarks:
- 1,4-dioxane, which was used for preparation of the test solution, was selected as the negative control article.
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2); 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)- aminopropylamino]acridine・2HCl (ICR-191); 2-Aminoanthracene (2AA
- Details on test system and experimental conditions:
- The test article (0.300 mL) was put into a sterilized test tube for preparation, and weighed. The weighed value was converted using the conversion factor of 0.86 calculated from the purity of 86%, the amount of vehicle in the test article suspension at the highest concentration of 100 mg/mL using sonication was calculated. Then, 1,4-dioxane was added to prepare the test article suspension at 100 mg/mL.
This test article suspension was diluted 6 times using a common ratio of 4 to prepare the test article suspension at a total of 7 concentrations: 50, 12.5, 3.13, 0.781, 0.195, 0.0488 and 0.0122 mg/mL. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation and Coloration by Test Article -
Neither precipitation nor coloration by the test article on the plate was observed at any dose levels irrespective of the presence/absence of metabolic activation
Growth Inhibition -
In the observation of bacterial background lawn using a stereoscopic microscope, growth inhibition was observed at 9.77 µg/plate or more for S. typhimurium TA1535 and TA1537 without metabolic activation, at 19.5 µg/plate or more for S. typhimurium TA98, TA100 and E. coli WP2 uvrA without metabolic activation, at 156 µg/plate or more for S. typhimurium TA100, TA1535 and TA1537 with metabolic activation and at 313 µg/plate or more for S. typhimurium TA98 and E. coli WP2 uvrA with metabolic activation
Number of Revertant Colonies
In the dose-finding test and two main tests, there was neither increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group nor dose-response for any strains irrespective of the presence/absence of metabolic activation - Conclusions:
- In the dose-finding test and the two main tests, there was neither increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group nor dose-response for any strains irrespective of the presence/absence of metabolic activation.
Since two-fold or more increase in the number of revertant colonies in comparison with the negative control group was observed in the positive control group for each tester strain, it was judged that the reactions of the bacterial strains to the mutagenic agents were suitable and thus the study was conducted appropriately.
In conclusion, COCAMIDE DIPA was judged to have no gene mutation inducibility (negative) under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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