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Toxicological information

Genetic toxicity: in vivo

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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 The only available information was a short inofficial English translation of an unpublished report that was submitted to the WHO that did not contain many details about conduct or results.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Translation of an unpublished report provided by Junshi Chen, Beijing, Chinese Center for Disease Control and Prevention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

Constituent 1
Chemical structure
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

Results and discussion

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%.