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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was cited in a reliable CIR monograph on the toxicity of Fluorphlogopite. No further information was provided.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics
Author:
Becker, L.C.
Year:
2012
Bibliographic source:
Cosmetic Ingredient Review

Materials and methods

Test guideline
Deviations:
not applicable
Remarks:
- no information available
Principles of method if other than guideline:
Information on the guideline followed are not available.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
synthetic fluorphlogopite
IUPAC Name:
synthetic fluorphlogopite
Details on test material:
no details provided.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
No information available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on study design:
No information available

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 9 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality reported
Clinical signs:
other: no adverse clinical signs

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of a published acute oral toxicity study in rats, the LD50 of Fluorphlogopite was > 9000 mg/kg bw.
Executive summary:

The acute oral toxicity of synthetic Fluorphlogopite was investigated in female Sprague-Dawley rats. The LD50 value was > 9000 mg/kg bw.