Registration Dossier

Administrative data

Description of key information

Acute Toxicity:
The substance was concluded to be of no systemic toxicity after a single ingestion. The inhalation of a highly saturated vapour-aerosol-air-mixture represents an unlikely acute hazard.
- Oral: LD50 > 8170 mg/kg bw (Sprague-Dawley rat, BASF test comparable to OECD TG 401)
- Inhalation: LC0 = approx. 0.23 mg/L (nominal) (rat, IHT comparable to OECD 403, adopted 1981)
- Dermal: no data

Key value for chemical safety assessment

Additional information

Oral:

In an acute toxicity study conducted by BASF AG (1975) according to an internal protocol comparable to the OECD TG 401 groups of 5 Sprague-Dawley rats/sex/dose were administered a limit dose of 8170 mg/kg bw (emulsion in 0.5% aqueous CMC) by gavage and observed for 7 days for lethality and clinical signs of intoxication. No mortality, clinical signs and pathologic abnormalities were observed. Thus, the LD50 for oral acute toxicity in rats was estimated to be > 8170 mg/kg bw (BASF AG, 1975; Val 2).

 

 

Inhalation:

Data on acute toxicity of Tris-2-ethylhexylamine by the inhalation route are limited. There is only an inhalation hazard test available where in total six rats/sex were exposed for 8 hours to vapour-aerosol atmospheres saturated with the volatile parts of the substance at a nominal concentration of 0.23 mg/L. The animals were observed for a post-exposure period of 7 days for clinical signs of intoxication. No mortality occurred. Clinical signs were slight irritation of mucous membranes. No pathologic abnormalities were observed at necropsy (BASF AG, 1975; Val 2).

 

 

Dermal:

No data available.

 

 

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute oral, dermal or inhalative toxicity is not warranted under Directive 67/548/EEC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute oral, dermal or inhalative toxicity is not warranted under Regulation (EC) No.1272/2008, as amended for the 2nd time in Commission Regulation (EU) No. 286/2011.