Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The old Russian research paper was from university journal, but the test is not standard test and it can not meet current criteria, because no detailed information was described for the rat strain and test procedure.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Chromosome aberration of potassium iodide was researched with embryonic liver cells of female rats. Stable iodine of 10 mg/kg is administered to the rats 7 days after fertilization. Then the embryonic liver was homogenated and the cells in metaphase were stained and checked under metaphase. The chromosome aberration cells were counted respectively for the concentration group and control group. The chromosome aberration rate in the concentration group was compared with that in the control group.
GLP compliance:
no
Remarks:
Old research paper
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Reference substance name:
Iodide in KI
IUPAC Name:
Iodide in KI
Constituent 2
Reference substance name:
Potassium iodide
EC Number:
231-659-4
EC Name:
Potassium iodide
Cas Number:
7681-11-0
IUPAC Name:
potassium iodide
Details on test material:
no data

Test animals

Species:
rat
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
7 days
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
10 mg/kg
Basis:
no data
No. of animals per sex per dose:
5 in each group; details please see the table 1
Control animals:
yes, concurrent no treatment

Examinations

Tissues and cell types examined:
Embryonic liver tissues (hepatocyte)

Results and discussion

Test results
Sex:
female
Genotoxicity:
negative
Remarks:
Not significant difference exists between concentration and control groups
Toxicity:
not examined
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
not examined

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The negative result was obtained from an in vivo chromosome aberration test for embryonic hepatocytes of female rats.