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

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Short description of key information:
Toxic on fertility: non toxic

Effects on developmental toxicity

Description of key information

Toxic on developmental: non toxic

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

No data the major component (ca 86 %) are available, but data of similar substances with a defined number of carbons and insaturation are available. No data on diesters are available. Information on products containing Cocamide DEA and diethanolamine has been taken into account, in fact, a small amount of diethanolamine (2-5%) is present in the intermediate, PRODUCT L6143.

Results of a study carried out on Coconut oil acid dithanolamine condensate, Comperlan KD (CAS 68603-42-9) are available. The study assesses the effects of embryonic and foetal development in pregnant Sprague-Dawley CD rats according to OECD guideline 414.

No deaths or treatment-related changes in body weight gain and necropsy findings were observed in dams at any dose level. Treatment-related symptoms observed in all groups were salivation and propulsion of the head. The highest dose group showed severe salivation.

Pre-implantation loss and mean numbers of resorptions were not affected by treatment.

The data for post-implantation loss, embryonic deaths and total foetuses showed some deviations which were considered to be non-treatment-related. Mean foetal placental and uterus weights were not affected by the treatment. Foetal sex ratio was comparable in all groups. No treatment-related foetal abnormalities were found at necropsy. The examined foetuses showed no treatment-related visceral and skeletal abnormalities/variations. One foetus at 300 mg/kg bw/day showed a stump tail and missing coccigycae vertebrae. Further, the data for skeletal ossifications showed some deviations in the two highest dose groups. However, all these effects were assessed to be non-treatment-related.

Based on the results, the similar substance was not considered to be toxic to pregnant Sprague-Dawley CD rats or to have any embryotoxic or teratogenic potential at dose levels up to 1.000 mg/kg bw/day.^{1 2 3 5}

Different studies and publications on diethanolamine with negative results are available.⁴

 

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

⁵Pittermann, W. 1994. Embryotoxicity Study (Including Teratogenicity) in the Rat (Segment II). Report number RT 920403. Henkel KGaA, Duesseldorf, Germany.

Justification for classification or non-classification

In order to classify the PRODUCT L6143 for carcinogenicity, 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 reproduction or development toxicity

Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5: not classified for reproduction or development toxicity

Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3: not classified for reproduction or development toxicity

Lauramide diethanolamine (LDEA) CAS 120-40-1: not classified for reproduction or development toxicity

Coconut fatty acid diethanolamide,Amides, coco, N,N-bis(hydroxyethyl)CAS 68603-42-9: not classified for reproduction or development toxicity

Diethanolamine CAS 111-42-2: not classified for reproduction or development 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 carcinogenicity the presence between 0.1% to >=1% shall be taken into account.

According to the CLP Regulation 1272/2008/EC, 3.7 section, point 3.7.3.1., Table 3.7.2, generic concentration limits shall be used to determine if the mixture is considered to be or not a toxic for the reproduction or the development.

Based on the information available, the intermediate PRODUCT L6143 is not classified as as reprotoxic or toxic for the development.