Registration Dossier
Registration Dossier
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EC number: 215-275-4 | CAS number: 1317-60-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP. Only a single sample was taken (at 24 hours).
Data source
Reference
- Reference Type:
- publication
- Title:
- Micronucleus tests in mice on 39 food additives and eight miscellaneous chemicals.
- Author:
- Hayashi M, Kishi M, Sofini T, Ishidate JRM
- Year:
- 1 988
- Bibliographic source:
- DOI 10.1016/0278-6915(88)90001-4 PMID 3169648 Food and Chemical Toxicology 26(6):487-500
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Only a single sample was taken (at 24 hours)
- Principles of method if other than guideline:
- Method: other
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Iron sulphate
- EC Number:
- 231-753-5
- EC Name:
- Iron sulphate
- Cas Number:
- 7720-78-7
- Molecular formula:
- FeO4S
- IUPAC Name:
- iron(II) sulfate
- Details on test material:
- - Name of test material (as cited in study report): Ferrous sulphate CAS number 7720-78-7
- Analytical purity: 87-65%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Strain : ddy
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Frequency of treatment:
- Single injection
- Post exposure period:
- Sampling time 24 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25, 50, 100, 180 mg/kg
Basis:
- No. of animals per sex per dose:
- 6 males (test) 2 males (control)
- Control animals:
- yes
- Positive control(s):
- Mitomycin C
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Remarks:
- % PCEs appeared to be unaffected by substance administration
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Negative
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Iron sulphate has been tested in a micronucleus study. No increase in micronucleated PCEs was observed in any dose 24 hours after sampling. It is concluded that the test substance is negative for the induction of micronuclei under the conditions of the test.
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