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Administrative data

Description of key information

This information is based on a study on a 28 day oral toxicity study using the read-across substance RA2.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

According to Annex VIII of Regulation (EC) No 1907/2006 REACH Regulation, repeated dose toxicity studies only need to be conducted on one species taking into consideration the most appropriate route of administration regarding human exposure. As the oral route of exposure is most appropriate for Triethanol amineacetate, repeated dose toxicity studies were not carried out for the dermal or inhalation routes.

The sub-chronic and long-term repeated dose toxicity studies were not required based on Annex VIII of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

Oral repeated dose toxicity studies on RA2 and RA1 with rats yielded NOAELs of 1000 mg/kg bw/day and 150 mg/kg bw/day respectively. According to Regulation (EC) No. 1272/2008, classification is applicable when significant toxic effects are seen to occur at 100 mg/kg bw/day or less for an oral rat study, which means that the NOAELs for these substances do not trigger classification. Therefore, it can be concluded that Triethanol amineacetate is also not classified since sameness has been established with these read across substances.