Registration Dossier
Registration Dossier
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EC number: 233-238-0 | CAS number: 10099-59-9
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral
A K2 acute oral toxicity test was performed in male and female Sprague-Dawley rats according to a guideline similar to OECD Guideline 401 (Cochran et al., 1950 and Lewis, 1995). The LD50 was calculated to be 4500 mg compound/kg bw. This study was selected as key study.
Acute toxicity: inhalation
No data are available for inhalatory exposure.
Acute toxicity: dermal
Bradshaw (2013a) performed an acute dermal toxicity study (limit test) in Wistar rats similar to the OECD 402 test guideline and EU Method B.3, using a semi-occlusive cover. The test item was the read-across substance lanthanum acetate, another soluble lanthanum compound. An unbounded LD50 value above 2000 mg/kg bw was derived for male and female rats. The read-across justification is added in Section 13 of IUCLID. A maximal reliability score of 2 (reliable with restrictions) is assigned because the study has been used for read-across purposes in this dossier.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute toxicity: oral
Cochran et al. (1950) and Lewis (1995) investigated the acute oral toxicity via gavage of a single oral dose of lanthanum trinitrate (50% solution) in 24 Sprague-Dawley rats in total. All animals were observed for 10 days. An initial group of animals receiving the test substance were kept for 30 days to verify if any significant mortality occurred after the tenth day. No further details on mortality and clinical signs were reported in the publication. The oral LD50 was calculated to be 4500 mg compound/kg bw. This study is considered the key study and it is scored as Klimisch 2.
Acute toxicity: inhalation
No data are available for this endpoint. However, no further testing is needed as 2 routes of exposure are already covered, according to REACH regulation (column 2, annex VIII, section 8.5). Furthermore, the substance is hygroscopic and forms aggregates. Therefore this study is not justified.
Acute toxicity: dermal
Read across to lanthanum acetate, another 'water-soluble' lanthanum compound, is performed to cover this endpoint. Bradshaw (2013a) performed an acute dermal toxicity study (limit test) in Wistar rats similar to the OECD 402 test guideline and EU Method B.3, using a semi-occlusive cover. After 24h of exposure to a single dose (2000 mg/kg bw), all animals (5 males, 5 females) were observed for 14 days. As no mortality occurred, an unbounded LD50 above 2000 mg/kg bw was observed for male and female rats. A maximal reliability score of 2 (reliable with restrictions) is assigned because the study has been used for read-across purposes in this dossier. The read-across justification is added in Section 13 of IUCLID
Justification for selection of acute toxicity – oral endpoint
There is only one study available for this endpoint. The derived LD50 is 4500 mg/kg bw.
Justification for selection of acute toxicity – inhalation endpoint
No further testing is needed as 2 routes of exposure are already covered, according to REACH regulation (column 2, annex VIII, section 8.5). Furthermore, the substance is hygroscopic and forms aggregates. Therefore this study is not justified.
Justification for selection of acute toxicity – dermal endpoint
Only one study is available for this endpoint. Read-across to lanthanum acetate is suggested.
Justification for classification or non-classification
Based on the available data and according to the criteria of the CLP Regulation (EC) 1272/2008, lanthanum trinitrate should not be classified as acute toxicant via the oral or the dermal route of exposure.
No data were available to decide on the classification for the inhalation route.
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