Registration Dossier
Registration Dossier
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EC number: 268-952-1 | CAS number: 68155-26-0
Endpoint summary
Administrative data
Description of key information
Oral: non toxic
Inhalation: no study available
Dermal: non toxic
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Oral
A study was performed to assess the acute oral toxicity of Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68155-07-7 in the Sprague-Dawley CD rat according to OECD Guideline 401, and a summary of the results available. A single dose was administered and the animals were observed for 14 days after the day of dosing. No mortalities were observed in the study.
No signs of systemic toxicity were noted during the study. All animals showed expected gain in body weight during the study. No abnormalities were observed at necropsy. The LD50 of the test material in the Sprague-Dawley CD rat was found to be greater than 2.000 mg/kg.1
Another similar study was performed on the same substance in the Wistar rat. Clinical signs like sedation and piloerection were reported in all animals following gavage and were recovered. There were no macroscopic changes in the organs on necropsy. No mortality was observed in either sex. The LD50 of the test material in the Wistar rat was found to be greater than 5.000 mg/kg.2
A study was performed to assess the acute oral toxicity of a vegetable similar substance Amides, soya, N,N-bis(hydroxyethyl), CAS 68425-47-8
on rats, according to OECD Guideline 401. After 14 days there were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals. Under the study conditions, the LD50 of the test susbtance in rat was found to be > 3,000 mg/kg bw. 3
Diethanolamine is well known as harmful if swallowed and it is classified for the oral route according to the Regulation (EC) No 1272/2008.4
Dermal
A study was conducted to determine the acute dermal toxicity of Amides, coco, N,N-bis(hydroxyethyl), CAS 68603-42-9, in male/female albino rabbit and a summary of results available. The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. A single application was applied to the abraded and intact skin of the test animals. Following the 24 hours exposure period, animals were observed for mortality, skin response and general behaviour for 14 days.
No mortality was observed in this study under the conditions of the test, the dermal LD50 value was found to be > 2000 mg/kg bw.1 3
No data on acute dermal toxicity on diethanolamine are present.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;
Justification for classification or non-classification
Oral
In order to classify the PRODUCT L6143 for the oral 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 oral toxicity
Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5: not classified for oral toxicity
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3: not classified for oral toxicity
Lauramide diethanolamine (LDEA) CAS 120-40-1: not classified for oral toxicity
Coconut fatty acid diethanolamide, Amides, coco, N,N-bis(hydroxyethyl) CAS 68603-42-9: not classified for oral toxicity
Dithanolamine, CAS 111-42-2: Index number 60 -071-00-1, H302
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, but it does not influence the final classification of the intermediate.
According to the CLP Regulation 1272/2008/EC, 3.1 section, based on the information available, the intermediate PRODUCT L6143 is not classified as an acute oral toxicant.
Dermal
In order to classify the PRODUCT L6143 for the dermal 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 dermal toxicity
Amides, C12-18 (even-numbered) and C18 (unsatd.), N,N-bis(hydroxyethyl), CAS 90622-74-5: not classified for dermal toxicity
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl), CAS 68603-38-3:not classified for oral toxicity
Lauramide diethanolamine (LDEA) CAS 120-40-1: not classified for dermal toxicity
Coconut fatty acid diethanolamide, Amides, coco, N,N-bis(hydroxyethyl) CAS 68603-42-9: not classified for dermal toxicity
Dithanolamine, CAS 111 -42 -2: not classified for dermal 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.
According to the CLP Regulation 1272/2008/EC, 3.1 section, based on the information available, the intermediate PRODUCT L6143 is not classified as an acute dermal toxicant.
Inhalation
No data are available regarding the acute inhalation hazard of all the components of the PRODUCT L6143.
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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