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Registration Dossier
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EC number: 204-823-8 | CAS number: 127-09-3
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This is not a standard genotoxicity test system, but it provides evidence that acetic acid, sodium salt is not genotoxic in animals.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
- Principles of method if other than guideline:
- This is not a routine genotoxicity test system. Method: 3H-thymidine incorporation measured.
- GLP compliance:
- no
- Type of assay:
- other: Testicular DNA-synthesis inhibition test (DSI test)
Test material
- Reference substance name:
- Sodium acetate
- EC Number:
- 204-823-8
- EC Name:
- Sodium acetate
- Cas Number:
- 127-09-3
- Molecular formula:
- C2H4O2.Na
- IUPAC Name:
- sodium acetate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 25- 30 g
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- A single administration
- Frequency of treatment:
- A single administration
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
500 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- No data on number of animals.
- Control animals:
- yes
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- 3H-thymidine incorporation in testicular cells
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- not specified
- Additional information on results:
- No inhibitory effect on DNA-replication was detectable.
Any other information on results incl. tables
No inhibitory effect on DNA-replication was detectable.
No inhibitory effect on DNA-replication was detectable in animals treated with Sodium Acetate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No inhibitory effect on DNA-replication was detectable in animals treated with Sodium Acetate. - Executive summary:
The Testicular DNA-synthesis inhibition test (DSI test) was performed on male mice with Sodium Acetate. This is not a standard genotoxicity test system, but it provides evidence that acetic acid, sodium salt is not genotoxic in animals. The basis of the method is to measure 3H-thymidine incorporation. Animals receive a single oral dose by gavage at concentrations of 200, 500, and 1000 mg/kg bw of test substance.
No inhibitory effect on DNA-replication was detectable in animals treated with Sodium Acetate.
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