Registration Dossier

Administrative data

Description of key information

Amix TE is not irritating to the skin or eyes. 

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)

Additional information

Since Amix TE (CAS 68953-70-8) is composed of at least 75 % of TEA (CAS 102-71-6) and the available data for Amix TE are limited, a read-across to TEA was conducted. In addition to the irritation studies for TEA mentioned below, a skin irrtation study (BASF AG, 18H0444/952166) and an eye irritation study (BASF AG, 11H0444/95216) with Amix TE were conducted:

In the skin irritation study, performed according to EU Method B.4 (GLP compliant), 3 rabbits were exposed to Amix TE using a semiocclusive application for 4 hours. Erythema and edema were scored at 24, 48 and 72 hours. No effects were observed.

In the eye irritation study, performed according to EU Method B.4 (GLP compliant), 3 rabbits were treated with 0.1 ml undiluted Amix TE. The eyes were washed with water 24 hours after dosing. Eyes were examined and scored 24, 48 and 72 hours after dosing with an iris score of 0, corena score of 0, conjunctivae score of 1 (not fully reversible within 72 hours) and an chemosis score of 0.2 (fully reversible within 72 hours), indicating no eye irritation.

In a skin irritation test performed according to OECD guideline 404 (non GLP-compliant), three rabbits were exposed to triethanolamine 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). 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 triethanolamine 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. Triethanolamine was not an eye irritant under the conditions of this study (Griffith, 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, 1971).

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.