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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Although no repeated dose toxicity study data is available for the registered substance, a sub-chronic repeated dose toxicity study is available on the read across substance, lanthanum tricarbonate. No adverse effects relating to treatment were observed during the 90 day (oral) study and so the NOAEL was determined to be 741 mg/kg bw/d for males and 1126 mg/kg bw/d females (actual dose ingested, based on anhydrous lanthanum tricarbonate)..

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Referenceopen allclose all

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
according to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
no
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: feed
Details on results:
ANALYSIS OF TEST SUBSTANCE IN VEHICLE
Homogeneity and stability of the test material in the diet were checked prior to study start. These analytical investigations showed the test material to be homogeneously distributed and stable in the concentration range used beyond the period of use. Analyses during the study verified that the test material content agreed with the target concentrations and that the test material was homogeneously distributed in the diet within the defined limits (Table 1).
Dose descriptor:
NOAEL
Effect level:
14 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse treatment-related effects were noted.
Critical effects observed:
no

For result tables 1 - 16 see attached document.

Endpoint:
sub-chronic toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
14 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse treatment-related effects were noted.
Critical effects observed:
no
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In accordance with information available for this substance, no classification for repeated dose toxicity is required under Regulation (EC) No. 1272/2008.