Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- other: no glp, study from a non oecd country
- Rationale for reliability incl. deficiencies:
- other: no glp, study from a non oecd country
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: in vivo cytogentic assay (Preston et al, 1987; WHO 1985)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- 7758-99-8
- Cas Number:
- 7758-99-8
- IUPAC Name:
- 7758-99-8
- Reference substance name:
- copper sulfate pentahydrate
- IUPAC Name:
- copper sulfate pentahydrate
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- once
- Frequency of treatment:
- once
- Post exposure period:
- 6, 12, 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
0
Basis:
other: mg / kg bw
- Dose / conc.:
- 1.1 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
1.1
Basis:
other: mg / kg bw
- Dose / conc.:
- 1.65 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
1.65
Basis:
other: mg / kg bw
- Dose / conc.:
- 3.3 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
3.3
Basis:
other: mg / kg bw
- Dose / conc.:
- 6.6 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
6.6
Basis:
other: mg / kg bw
- No. of animals per sex per dose:
- 6 per dose and sampling time
- Control animals:
- yes
Examinations
- Tissues and cell types examined:
- bone narrow
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
Copper sulfate may thus be considered to be a moderately genotoxic agent despite the fact that copper is an essantial element.
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