Sodium feredetate

Genetic toxicity: in vivo

Administrative data

Endpoint:

genetic toxicity in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

no data

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed by the Sichan Provincial Sanitary and Anti-Epidemic Station in 1993. The only available information was a short inofficial English translation of an unpublished report that was submitted to the WHO that did not contain many details about conduct or results. The criteria for positive results not listed.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

secondary source

Title:

Tests and results in toxicological evaluation on safety of NaFeEDTA

Author:

Sichuan Provincial Sanitary and Anti-epidemic Sstation

Year:

1993

Bibliographic source:

Translation of an unpublished report provided by Junshi Chen, Beijing, Chinese Center for Disease Control and Prevention

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The test was conducted according to methods described in the Procedures and Methods for Toxicology Assessment in Food Safety Evaluation, National Standard for the People's Republic of China, 1994(GB15193.3-94)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium feredetate

EC Number:

239-802-2

EC Name:

Sodium feredetate

Cas Number:

15708-41-5

Molecular formula:

C10H12N2O8FeNa

IUPAC Name:

iron(3+) sodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative

Executive summary:

Type	:	micronucleus assay
Species	:	mouse
Strain	:	other:
Sex	:	male/female
Route of Administration	:	gavage
Exposure Period	:
Doses	:	50, 100, 200, 400 mg/kg
Result	:	negative
Method	:	other
Year	:	1998
GLP	:	no data
Test substance	:	as prescribed by 1.1 - 1.4
Remark	:	Two sets of results were reported. It is assumed that these results were for 2 different harvest times; however, this was not mentioned in the test.
Result	:	The number of micronucleated cells (per thousand) in the negative control for the first data set was 1.00 +/- 0.71. The number of micronucleated cells (per thousand) in treated animals ranged from 1.00 +/- 0.71 at 200 mg/kg to 3.40 +/- 4.88 at 100 mg/kg. The result at 1000 mg/kg was not considered to be positive. The positive control cyclophosphamide induced 11.60 +/- 4.04 micronucleated cells (per 1000).   The number of micronucleated cells (per thousand) in the negative control for the second data set was 1.20 +/- 0.45. The number of micronucleated cells (per thousand) in treated animals ranged from 1.00 +/- 0.71 at 50 and 100 mg/kg to 1.80 +/- 1.10 at 200 mg/kg. The positive control cyclophosphamide induced 11.00 +/- 2.92 micronucleated cells (per 1000).   The results of the test were considered to be negative by study personnel. The criteria for a positive test were not listed.
Test condition	:	Eight week old mice (males 26.9 +/- 9 +/- 1.8 g and females 27.2 +/- 1.4 g) were intubated with 0, 50, 100, 200 or 400 mg/kg NaFeEDTA or 40 mg/kg cyclophosphamide (positive control). The time of cell harvest was not stated. The test was conducted according to methods described in the Procedures and Methods for Toxicology Assessment in Food Safety Evaluation, National Standard for the People's Republic of China, 1994(GB15193.3-94). No other test details were listed.
Test substance	:	Purity of the test material was 91.1%.