Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: read-across with Pravastatin sodium
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Pravastatin sodium
IUPAC Name:
Pravastatin sodium

Administration / exposure

Route of administration:
other: oral

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD 50 oral Pravastatin sodium >12000 mg/kg (rat)
Executive summary:

LD 50 oral Pravastatin sodium >12000 mg/kg (rat)

The company classified it as acute toxicity oral category 4 - H302 (precautionary principle)