1-Propanol, 3-(dimethylamino)-, hydrochloride (1:1)

Endpoint summary

Description of key information

in vitro: Skin: not corrosive, EpiDerm TM corrosivity test, BASF 2002 (61H0616/002182)
               Eye: not corrosive, Het-CAM Test, BASF 2002 (60H0616/002183)
in vivo:  Skin: not irritating, OECD 404, BASF 2002 (18H0616/002206)
               Eye: not irritating, OECD 405, BASF 2002 (11H0616/002301)

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

Skin:

An in vitro study was done by BASF in 2002 (EpiDerm TM corrosivity test). The test substance was tested at a concentration of 100% for its skin irritating potential in an in vitro test with human skin culture (EpiDerm TM). The viability of the treated cells in % of the negative control was determined. In this in vitro test the test substance proved to be non corrosive following the criteria of the Annex VI of the Commission Directive 67/548/EEC but a skin irritating potential could not be exluded. Therefore a further study according to OECD Guideline 404 was done by BASF (2002). The unchanged test substance was administered onto the intact skin of two White New Zealand rabbits under semiocclusive conditions for 4 hours. Readings for skin irritation findings (i.e. erythema, edema) were done 1, 24, 48 and 72 h after removal of the patch. The only finding was slight erythema in both animals at the 1-h reading. Thereafter no findings were seen. Thus, the test substance is not irritating to the skin under the test conditions chosen.

Eye:

An in vitro study was done by BASF in 2002. The test substance was tested in vitro in the HET-CAM Test. Undiluted test substance and 10% test substance in doubly distilled water was tested with each 3 eggs. After application of the test substance on the chorion-allantois membrane of the eggs the time until appearance of hemorrhagia, lysis and coagulation was examined and the index of irritation calculated. The experiment with the undiluted test substance led to coagulation within 56.0-71.0 seconds which leads to a mean index of irritation of 7.1. The experiment with 10% test substance in doubly distilled water led to in irritation index of 0.0. Since the results of the test were equivocal an additional in vivo study was performed by BASF in 2002 according to OECD 405. In this study, two White New Zealand rabbits were used. The test substance was applied undiluted into the conjunctival sac of one eye of both animals. Readings for eye irritation findings were performed 1, 24, 48 and 72 h as well as 7 d after test substance application. At the 1-h reading both animals showed marked redness and chemosis (score 2) as well as slight discharge. At the 24-h reading marked redness was still seen in the treated eyes of both animals. In 1/2 animals slight chemosis (score 1) was observed. Slight redness of the conjunctivae (score 1) persisted in both animals until the 72-h reading but was reversible within 7 days. The test substance is assessed as being not irritating to the eyes of rabbits under the present test conditions.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin and eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.