Registration Dossier

Administrative data

Description of key information

The substance was tested in standard rabbit skin and eye irritation tests and was found to be non-irritant to rabbit skin and only mildly irritaitng to rabbit eyes. Based on the results of these studies no respiratory irritation potential is expected.

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

In a primary dermal irritation study (Lambert CE et al, 1993), 6 New Zealand Albino rabbits were dermally exposed to 0.5 g of lanthanum oxide (purity unknown) for 24 hours to ca. 2.5 cm² of one intact and one abraded skin site. Test sites were covered with an occlusive dressing for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize. No signs of irritation were observed 24 or 72 hours after patch removal and wiping off of the test substance. It can be concluded that the test substance is not irritating to rabbit skin and is unlikely to be a human skin irritant.

In a primary eye irritation study (Lambert CE, 1993),

0.1 g of the test substance (purity unknown) was instilled to the left eye of 3 New Zealand White Rabbits without rinsing and 3 rabbits with rinsing after 30 seconds. The animals were then observed for 3 days and the irritation reaction scored according to the method of Draize. According to the scale of Draize mean irritation scores for unrinsed eyes were 13, 3.7 and 0.7 after 24, 48 and 72 h respectively and for the rinsed eyes 9, 2 and 0 (maximum score 110). It was concluded that the substance is mildly iritating to the unwashed eye and minimally irritating when washed after 30 seconds. Based on the irritation score, the EU classification criteria for irritancy to eyes are not met.

Justification for classification or non-classification

The substance was tested in standard rabbit skin and eye irritation tests and was found to be non-irritant to rabbit skin and only mildly irritaitng to rabbit eyes. The eye irritation score does not warrant a classification as eye irritant. Based on the results of these studies also no respiratory irritation potential is expected.

Therefore Lanthanumtrioxide is not classified for skin, eye or respiratory irritation.