Registration Dossier

Administrative data

Description of key information

This summary is based on the effect level of Read Across substance 1 (RA1) in the acute oral toxicity study, and Read Across substance 2 (RA2) in the acute dermal toxicity study. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

According to Annex VI of Regulation (EC) No. 1907/2006, acute toxicity studies need only be provided for the oral route and one other route. As read-across studies have been provided for acute oral and dermal toxicity, an acute inhalation toxicity study is not considered to be required.

Justification for classification or non-classification

Inhalation

Inhalation exposure will not be a danger for Triethanol amineacetate. As the substance will always be present in liquid form with a low vapour pressure (0.116 Pa at 20 °C), exposure to humans via inhalation is unlikely to occur.

The substance does not meet the criteria to be classified dangerous

 

Dermal

A skin sensitisation study carried out on Triethanol amineacetate showed it to be not sensitising, thereby not triggering classification. Furthermore, skin sensitisation and skin irritation studies carried out on Read Across substances RA2 and RA1 were also negative. Since sameness has been established for these read across substances, these results further prove that Triethanol amineacetate is not harmful to skin.

 

The substance does not meet the criteria to be classified dangerous

Acute

According to Regulation (EC) No. 1272/2008, classification is applicable when the acute oral LD50 is less than or equal to 2000 mg/kg body weight. Studies carried out on RA2 and RA1 resulted in LD50 values of 7500 mg/kg body weight and greater than 2000 mg/kg body weight respectively. Therefore, it can be concluded that Triethanol amineacetate is not classified since sameness has been established with these read across substances.

 

According to Regulation (EC) No. 1272/2008, classification is applicable when the acute dermal LD50 is less than or equal to 2000 mg/kg body weight. Studies carried out on RA2 and RA1 resulted in LD50 values greater than 2000 mg/kg body weight. Therefore, it can be concluded that Triethanol amineacetate is not classified since sameness has been established with these read across substances.