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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin

A study on the sensitizing potential of amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155- 07-7 is available. It was performed in a guinea-pig maximisation test according to OECD Guideline 406. No animals showed any effects to the treatment and this similar substance is therefore considered non-sensitizing.¹

Another available study was performed to determine the delayed contact hypersensitivity potential of amides on the same substance. Test material did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitizing.^{1 2}

A study on a similar vegetable substance Amides, soya, N,N-bis(hydroxyethyl), CAS 68425-47 -8 is available. No animals showed any effects to the treatment.³

Results on many studies on human volunteers or epidemiological studies are available on Cocamide DEA. This substance is considered as a definitive occupational allergen (dermatitis).⁴

Diethanolamine is not a sensitizing substance.⁵

 

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;

⁴Amended Final Report on the Safety Assessment of Cocamide DEA, Journal of the American College of Toxicology, 15 (6): 527-542, Cosmetic Ingredient Review, 1996.

⁵ECHA Registration Dossier 2,2'-iminodiethanol CAS 111-42 -2

Migrated from Short description of key information:
Skin sensitization: not sensitizer

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin sensitization

In order to classify the PRODUCT L6143 for the skin sensitization, the available classification (from Hrmonized 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 as skin sensitizer

Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5: not classified as skin sensitizer

Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3: not classified as skin sensitizer

Lauramide diethanolamine (LDEA) CAS 120-40-1: not classified as skin sensitizer

Coconut fatty acid diethanolamide,Amides, coco, N,N-bis(hydroxyethyl)CAS 68603-42-9: not classified as skin sensitizer. However it is considered as a definitive occupational allergen (dermatitis).

Diethanolamine, CAS 111 -42 -2: not classified as skin sensitizer

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.

All the components are not classified as skin sensitizer, however a concern about dermal occupational exposure can be considered, if short length chain of fatty acids are used for the production.

According to the CLP Regulation 1272/2008/EC, 3.4 section, point 3.4.3.3, Table 3.4.5, generic concentration limits shall be used to determine if the mixture is considered to be an non skin sensitizer.

Based on the information available, the intermediate PRODUCT L6143 is not classified as a skin sensitizer.