Registration Dossier

Administrative data

Description of key information

About Samarium oxide no studies were available, but about the analogue substance Lanthanum carbonate:
Skin:
not irritating to skin (rabbit, semiocclusive, 4h)
Eye:
not irritating to eye (rabbit, 0.1 g)
Respiratory irritation:
no data available

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 irritation

In a primary dermal irritation study according to OECD 404 three New Zealand White rabbits (1 male and 2 females) were dermally exposed to moistened Lanthanum carbonate (containing water) for 4 hours under semiocclusive conditions (Ott, 2005). Animals then were observed for 3 - 4 days. No erythema and edema were observed at 24, 48 and 72h, mean scores for erythema and edema were 0, 0, 0 and 0, 0, 0 respectively. Therefore, in this study Lanthanum carbonate (cotaining water) is not a dermal irritant.

In a further acute dermal toxicity test according to the Guideline of the Department of Transportation (D.O.T), Code of Federal Regulations, Title 49, Part 173, the intact skin of rabbits was treated with Lanthanum carbonate monohydrate for 24 h under occlusive conditions (Ward, 1976). 24 and 48 h after removal of the patch, the treatment sites were evaluated for signs of erythema or edema according to the Draize Scoring System. No signs for erythema and edema were observed, so Lanthanum carbonate monohydrate and therefore, Lanthanum carbonate was not irritating to the skin.

 

Eye irritation

In a primary eye irritation study according to OECD 405 0.1 g of Lanthanum carbonate (containing water) as such was instilled into the conjuntival sac of the left eye of rabbits (1 male, 2 females) (Ott, 2005). Eyes were not washed. Animals then were observed for 6 days for corneal opacity, iritis, conjunctivae and chemosis. Mean scores after 24, 48 and 72 h for corneal opacity, iritis, conjunctivae and chemosis were 0, 0, 0.89 and 0, respectively. Effects observed were fully reversible within the observation period. So in this study, Lanthanum carbonate (containing water) is considered as non irritating to eyes.

Furthermore, the eye irritation was investigated according to the Guideline of the Department of Transportation (D.O.T), Code of Federal Regulations, Title 49, Part 173 (Ward, 1976). 100 mg powder Lanthanum carbonate monohydrate were instilled in the eyes of rabbits and without removement, the eyes were examined up to 72 h after instillation. None of the rabbits showed swelling of lids or any redness of conjunctivae, even no changes of iris or the cornea could be observed in the animals. So, Lanthanum carbonate monohydrate and therefore, Lanthanum carbonate was not irritating to the eye.

 

Justification for classification or non-classification

The data on skin and eye irritation are conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and 1272/2008/EC (CLP).