Brightener 0503E

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

Study period:

2008-08-22 to 2008-10-01

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

For the Comet assay no internationally accepted guideline is available. This study was conducted according to the procedure indicated by the following recommendations:
Tice, R.R. et al. (2000): Single Cell Gel/Comet Assay: Guidance for In Vitro and In Vivo Genetic Toxigology Testing. Environmental and Molecular Mutagenesis 35: 206-221;
Hartmann, A. et al. (2003): Recommendations for conducting the in vivo alkaline Comet. Assy. Mutagenesis 18 (1): 45-51.

GLP compliance:

yes

Type of assay:

mammalian comet assay

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

deionised water

Details on exposure:

treated with a single oral dose of 1000 or 2000 mg/kg b.w. 4 or 16 h prior to preparation of the cells. The administration volume was 10 ml/kg b.w.

Frequency of treatment:

once

No. of animals per sex per dose:

6 males

Control animals:

yes

Positive control(s):

Methylmethansulfonate.

Examinations

Tissues and cell types examined:

liver: primary hepatocytes
intestinal cells

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Remarks:

at 2000 mg/kg b.w

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative Oral administration of 1000 and 2000 mg of the test item/ kg b.w. did not induce any DNA-damage in the in vivo Comet assay performed in liver cells and cells from the small intestine isolated 4 or 16 hours after administration of the test item.

Executive summary:

Based on the experimental conditions reported, oral administration of 1000 and 2000 mg of the test item/ kg b.w. did not induce anyDNA-damage in the in vivo Comet assay performed in liver cells and cells from the small intestine isolated 4 or 16 hours after administration of the test item. Therefore, the test item is considered to be non-genotoxic in thisin vivoalkaline single cell gel electrophoresis assay.