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EC number: 268-952-1 | CAS number: 68155-26-0
- 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 vitro toxicity: test on bacteria
Results from a study conducted on the similar substance C8-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155- 07-7 are available. The test was performed to determine the mutagenic potential of the test substance in the Salmonella typhimurium reverse mutation assay (strains TA 1535, TA 1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay strain WP2 uvrA in the presence and absence of metabolic activation (S9 -mix), according toOECD Guideline 471 (Bacterial Reverse Mutation Assay).
The test substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2 uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
Based on the results of this study it is concluded that the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.1 2
In other two studies the same similar substance was tested, with negative results in all conditions.1 2
Data from a study on a similar vegetable substance Amides, soya, N,N-bis(hydroxyethyl), CAS 68425-47 -8 is available.
The study was conducted according to EU Method B.13/14 on Salmonella typhimurium.
The test concentration was 5000 µg/plate. The test substance was found to be non-mutagenic under the conditions of this test.3
The similar substance Coconut oil acid diethanolamine condensate did not show genotoxic activity in vitro, in fact, it was not mutagenic in Salmonella typhimurium, with and without S9 activation enzyme.6
Data on the other similar substance Lauric acid diethanolamine condensate LDEA, CAS 120-40-1 are reported on the NTP full Technical report.
The substance was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation enzymes.7
Mammalian cell/in vivo genotoxicity
Coconut oil acid diethanolamine condensate, CAS 68603-42-9 did not produce an increase in the frequency of mutant colonies of L5178Y mouse lymphoma cells and in the frequencies of sister chromatid exchanges or chromosomial aberrations in Chinese hamster ovary cells.3 6
In addition, no increase in the frequency of mutant colonies of L5178Y mouse lymphoma cells was noted after exposure to lauric acid diethanolaminecondensate, CAS 120 -40 -1with or without S9. In cytogenetic tests with cultured Chinese hamster ovary cells, the substance was shown to induce sister chromatid exchanges, but not chromosomal aberrations, with and without S9.7
Different publication of in vitro tests on diethanolamine, CAS 111-42-2 are reported. All results are negative.4
In vivo toxicity
Results from a study conducted to determine the chromosome-damaging effect of amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7 in NMRI mice, according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) and Method No. 431, Annex V of EEC Directive 79/831 are available.
The similar substance did not induce an increase in the frequency of micronucleated normochromatic erythrocytes in peripheral blood samples from both male and female mice.
Therefore the substance was non-mutagenic under the conditions of this test.1 2 3
For the similar substance Coconut oil acid diethanolamine, CAS 68-603-42-9, positive results were obtained in a peripheral blood micronucleus test in male and female mice from the 14 week dermal study. 3 6
A study on oleic acid diethanolamine condensate CAS 93-83-4, has been performed and data available.
The test substance was applied dermally for 13 wk at 0, 50, 100, 200, 400 and 800 mg/kg bw. Under the conditions of the test, structurally similar test substance did not increase the frequencies of micronucleated normochromatic erythrocytes (NCEs) in peripheral blood of both male and female mice at the end of 13 wk.3
In vivo, no increase in the frequency of micronucleated normochromatic erythrocytes was observed in peripheral blood samples from male and female mice treated dermally with lauric acid diethanolamine condensate LDEA, CAS 120-40-1 for 14 weeks.3 7
Results from an in vivo study on diethanolamine, CAS 111-42-2 are reported. All results are negative.4
Reference:
1ECHA Registration Dossier Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7
2ECHA Registration Dossier Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5
3ECHA Registration Dossier Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3;
4ECHA Registration Dossier 2,2'-iminodiethanol CAS 111-42 -2
5Amended Final Report on the Safety Assessment of Cocamide DEA, Journal of the American College of Toxicology, 15 (6): 527-542, Cosmetic
Ingredient Review, 1996.
6Toxicology and carcinogenesis studies of coconut oil acid diethanolamine condensate (CAS 68603 -42 -9) in F344/N rats and B6C3F1 mice, dermal studies, NTP TR 479, NIH Publication N. 01-3969, January 2001
7Toxicology and carcinogenesis studies of lauric acid diethanolamine condensate (CAS 120 -40 -1) in F344/N rats and B6C3F1 mice, dermal studies, NTP TR 480, NIH Publication N. 01-3970, July 1999
Short description of key information:
In vitro toxicity on bacteria: non genotoxic
In vivo toxicity: non genotoxic
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In order to classify the PRODUCT L6143 for the genetic toxicity, the available classification (from Harmonized classification, Registration dossier and CLP notification) and the results of the reported studies of every known component and the similar substances have been taken into account.
Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7: not classified for genetic toxicity
Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5: not classified for genetic toxicity
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3: not classified forgenetic toxicity
Lauramide diethanolamine (LDEA) CAS 120-40-1: not classified for genetic toxicity
Coconut fatty acid diethanolamide, Amides, coco, N,N-bis(hydroxyethyl)CAS 68603-42-9: not classified for genetic toxicity
Diethanolamine CAS 111-42-2: not classified for genetic toxicity
Amides, vegetable-oil, N,N-bis(hydroxyethyl) are the major component (a 86 %), followed by diesters of fatty acids of diethanolamine.
A small amount of diethanolamine (2-5%) is present, and for the evaluation of the genetic toxicity the presence between 0.1% to >=1% shall be taken into account.
According to the CLP Regulation 1272/2008/EC, 3.5 section, point 3.5.3.1, Table 3.5.2, generic concentration limits shall be used to determine if the mixture is considered to be or not a genotoxic.
Based on the information available, the intermediate PRODUCT L6143 is not classified as genetic toxicant, in vitro and in vivo.
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.
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