Registration Dossier

Administrative data

Description of key information

Irritation:
- skin: not irritating (rabbit, internal BASF-protocol, occlusive application for 1 min, 5 min, 15 min and 20 h)
- eyes: not irritating (rabbit, comparable to OECD TG 405)
- respiratory tract: not irritating

Key value for chemical safety assessment

Additional information

Skin irritation:

In a study according to an internal protocol undiluted tris(2-ethylhexyl)amine was applied under occlusive conditions to the skin of rabbits for one minute, 5 minutes, 15 minutes and 20 hours, respectively. Occlusive exposure caused slight to moderate reddening of the dorsal rabbit skin extending beyond the area of exposure. Mean erythema scores (24-48 h) were 1.75 (1 min), 1.5 (5 min), 1.5 (15 min) and 2.5 (20 h). Mean edema scores (24-48 h) were 0 (1 min), 0 (5 min), 0 (15 min) and 0.5 (20 h). Since the readings after 72 h were missing from the raw data, only readings after 24 and 48 h were taken into consideration for scoring.

At the end of the observation period of 8 days erythema and edema had fully reversed. The animals showed scale formation at all exposure times. In case of the 20 h application scaling was extending beyond the area of exposure (BASF AG 1975; Val. 2).

Since application for 20h under occlusive dressing gives overpredictive results as compared to the specifications of the OECD TG 404, only the effects after 1, 5, and 15 min application were considered for estimating the skin irritation potential of the substance. Taking all the relevant data into account, tris(2-ethylhexyl)amine is not considered irritating to rabbit skin.

 

 

Eye irritation:

In a study comparable to OECD TG 405 undiluted tris(2-ethylhexyl)amine (0.05 mL) was instilled into one eye of two rabbits. The adjacent eyes were treated with saline and served as control. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. Mean scores for cornea, iris, conjunctivae and chemosis (24-48-72 hours) were 0, 0, 1, and 0, respectively. All effects were fully reversible within 8 days (BASF AG, 1975; Val 2).

Thus, the substance is not irritating to the eyes of rabbits.

 

 

Respiratory irritation:

There exists no standard test method for the assessment of respiratory irritation. There is some evidence from the described inhalation hazard test that tris(2-ethylhexyl)amine vapours may be slightly irritating to the mucous membranes of rats (BASF AG 1975; Val. 2).

 


Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

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 irritation / corrosion 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 irritation / corrosion is not warranted under Regulation (EC) No.1272/2008, as amended for the 2nd time in Commission Regulation (EU) No. 286/2011.