Registration Dossier

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:
1981

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
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
not specified
Sex:
male
Details on test animals 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.