Registration Dossier

Administrative data

Description of key information

ORAL EPOSURE:  One acute oral fixed dose study according to OECD 420 and EU B.1 bis acute oral toxicity guidelines.
DERMAL EXPOSURE: no specific test data available; this endpoint is waived.
INHALATION EXPOSURE: One acute inhalation study according to OECD 403 is available, performed with Lanthancarbonate-octahydrate (read-across)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
discriminating conc.
Value:
5 928 mg/m³

Additional information

ORAL EXPOSURE

One acute oral fixed dose study has been conducted according to OECD Guideline 420. The acute LD50 of the substance has been determined to be greater than 2000 mg/kg. It is considered to be reliable (Klimisch score 1) and was conducted in compliance with GLP. The study showed that the substance was not acutely toxic and does not need to be classified.

DERMAL EXPOSURE

No specific test data are available on the dermal acute toxicity of the test substance. In accordance with Column 2 of Annex VIII the acute dermal toxicity study (as required in section 8.5.3) is not considered scientifically justified as the oral and inhalation exposure routes are considered most appropriate to assess the acute toxicity hazard presented by the substance based on its physico-chemical characteristics and use pattern. Furthermore, dermal absorption of the substance is considered unlikely.

INHALATION EXPOSURE

One acute inhalation study has been conducted according to OECD Guideline 403 and using lanthanum carbonate as the test substance (read-across). The acute inhalation LC50 of the substance was determined to be greater than 5928 mg/m3. It is considered to be realiable and conducted in compliance with GLP. A Klimisch score of 2 has been assigned because reading-across. The study showed that the substance was not acutely toxic by inhalation and does not need to be classified.

A DNEL for acute toxicity needs only to be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures. In the absence of these criteria being met, no acute DNELs have been derived.

Justification for classification or non-classification

A GLP-compliant acute oral toxicity study in the rat has been conducted according to OECD 420 and EU B.1. The acute oral LD50 has been determined to be greater than 2000 mg/kg. In this study, the LD50 is greater than the cut-off value for C&L.

A GLP-compliant acute inhalation toxicity study in the rats has been conducted according to OECD 403 and EU B.2, using lanthancarbonate-octahydrate as the test substance (read-across). The acute inhalation LC50 has been determined to be greater than 5928 mg/m3. In this study, the LC50 is greater than the cut-off value for C&L.

On these bases the substance is not classified for acute toxicity in accordance with the EU DSD or CLP regulation.