Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated

Endpoint summary

Description of key information

The test substance was tested in an acute oral toxicity study according to EU method B.1 bis cited as Directive 96/69/EEC in Wistar rats. No treatment related toxic effects were observed at the dose level of 2000 mg/kg bw. The acute oral discriminating does was determined to be 2000 mg/kg bw. The result is supported by an acute dermal study with a close homologue (please refer to ch. 13 for read-across justification) that led to the same result (LD50 > 2000 mg/kg).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline compliant study.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity

In an acute oral toxicity study according to EU method B1 cited as Directive 79/831/EWG , the test substance was administered by oral gavage to five Wistar rats of each sex at 2000 mg/kg bw. The test substance was administered at 10 mL/kg bw using water as vehicle. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 14 days. All gross and visible toxic or pharmacological effects were recorded. No animals died on account of the treatment nor did they show serve signs of toxicity. The oral discriminating dose value of the test substance in Wistar rats was estimated to be 2000 mg/kg bw.

Acute inhalation toxicity

In accordance with column 2 of REACH Annex VIII, testing of the acute toxicity by inhalation is not appropriate as the substance is a liquid with a low vapour pressure (≤ 0.51 Pa (0.51*10-2 mbar) at 20 °C) and inhalation of the substance is unlikely.

Acute dermal toxicity

A single application of 2,000 mg/kg bw of structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) applied to the abraded and intact skin of the test animals resulted in no mortality and all animals appeared normal throughout the 24 hour exposure period and during the 14 day post-exposure observation period. The dermal LD₅₀was determined to be >2,000 mg/kg bw which indicates a low acute dermal toxicity (Palanker AL, 1976) and therefore based on read across this substance is also expected to have low acute dermal toxicity.

Furthermore, the acute oral toxicity test conducted with the target substance gave no indication for an acute toxic potential of the target substance. On the basis of the dermal absorption studies with a structural homologue, and considering the high lipophilicity, a dermal uptake can be expected for the target substance.

It has also to be taking into account that the target substance is classified as skin sensitizing, and thus the application of suited risk management measures such as gloves is prescribed. Therefore, the dermal exposure is assumed to be negligible on a qualitative basis.

Justification for selection of acute toxicity – oral endpoint
Only one GLP and guideline compliant study available.

Justification for classification or non-classification

Based on the results obtained in the acute oral toxicity study the test substance has not to be classified with respect to acute oral toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP, GHS).