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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Iron digluconate
EC Number:
206-076-3
EC Name:
Iron digluconate
Cas Number:
299-29-6
Molecular formula:
C12H22FeO14
IUPAC Name:
λ²-iron(2+) bis((2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate)
Details on test material:
Ferrous gluconate

Test animals

Species:
Drosophila melanogaster
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
10 days

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative

Any other information on results incl. tables

Ferrous Gluconate was not mutagenic at any exposure level used. Ferrous Gluconate was devoid of mutagenic properties.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
ferrous gluconate is devoid of mutagenic properties.
Executive summary:

This substantial paper is principally an introduction to the method. The Drosophila test is considered to check for mutations at 600 to 800 loci. It can detect both point mutagens and promutagens which require activation. Ferrous gluconate was one of 421 substances tested. The objective being to correlate known carcinogenic properties with this mutagenic end-point. The authors of the study, reviewed in this US-EPA report, found ferrous gluconate to be devoid of mutagenic properties.