Registration Dossier

Administrative data

Description of key information

Triethanolamine is not irritating to the skin, eyes and respiratory tract. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In a skin irritation test performed according to OECD guideline 404 (not GLP-compliant), three rabbits were exposed to TEA using an occlusive application for 4 hours. Erythema and edema were scored at 4, 24, 48, and 72 hours and the mean score was 0. The test substance was not a skin irritant under the conditions of this study (BASF, 1983).Several other studies, in which rabbits were exposed for up to 20 hours, yielded similar results (BASF 1956, 1966, 1967, 1971).

In a study with 6 human volunteers, 2 cm2-patches soaked with the test material were applied for 24 hours to the upper arm, and skin irritation was scored upon patch removal and 24 hours thereafter (BASF AG, 1930). Besides slight biting and reddening in 1 subject, no irritation was observed and thus, the test substance was judged non-irritating.

 

In an eye irritation test equivalent to OECD guideline 405 (non GLP-compliant), 6 rabbits/dose were exposed to undiluted TEA at dose volumes of 0.01, 0.03, and 0.1 ml. The eyes were not irrigated. Eyes were examined and scored according to Draize et al. (1944) 1, 3, 7, 14, and 21 days after dosing. TEA was not an eye irritant under the conditions of this study (, 1980). The same conclusion was reached in an eye irritation test (non GLP-compliant, according to internal BASF standards), in which 50 µl of the test substance was instilled into the eyes of 2 rabbits, and irritation was scored 10 min, 1 and 24 hours and 8 days after administration (BASF AG, 1971). In addition, no eye irritation was observed in response to the application of 0.5 mL 20% TEA in water at pH 10 and pH 8 (BASF AG, 1956). Two other studies (performed according to internal BASF standards) demonstrated some mild irritation due to the application of 50 µl undiluted TEA to the rabbit eye, which was not fully reversible within 8 days in one animal (BASF AG, 1966, 1967). Overall, TEA is judged not to be irritating to the eyes.

Justification for classification or non-classification

Findings do not meet the critera for classification as skin or eye irritant according to EU Directive 67/548/EEC and EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.