Amides, vegetable-oil, N,N-bis(hydroxyethyl)

Endpoint summary

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.