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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro DNA damage and/or repair study
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comet assay not performed using GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Principles of method if other than guideline:
A single cell gel/comet assay in mammalian cells for detection of DNA damage was performed.
GLP compliance:
no
Type of assay:
comet assay

Test material

Constituent 1
Details on test material:
- Purity: highest purity available

Method

Target gene:
SV-40 immortalized human uroepithelial cell lines (SV-HUC-1)
Species / strain
Species / strain / cell type:
mammalian cell line, other: SV-40 human uroepithelial cell lines (SV-HUC-1)
Details on mammalian cell type (if applicable):
- Cell line obtained from American Type Culture Collection (ATCC, Wiltshire, USA)
- The mouse monoclonal primary antibody used was p53 PAb240 (NCL-p-53-240) from Novocastra (Newcastle, UK). The rabbit polyclonal antibody COX-2 (CP222C) was from BioCare Medical (Concord, Canada).
Metabolic activation:
not applicable
Test concentrations with justification for top dose:
0, 2, 5, 10, 20, and 40 µg/mL

Results and discussion

Test results
Species / strain:
mammalian cell line, other: SV-40 human uroepithelial cell line SV-HUC-1
Metabolic activation:
not applicable
Genotoxicity:
positive
Remarks:
as increased density of mutant p53 and COX-2 protein expression
Cytotoxicity / choice of top concentrations:
cytotoxicity

Any other information on results incl. tables

Test substance treatment reduced cell viability in a dose-dependant manner. The test substance caused DNA damage on SV-HUC-1 cells. The report shows the expression level of mutant p53 and COX-2 analysis by immunocytochemistry analysis after treatment with the test substance in SV-HUC-1 cell lines. Test substance treatment increased mutant p53 and COX-2 proteins expression.

Applicant's summary and conclusion

Conclusions:
Under the conditions employed in this study, test substance exposure resulted in cytotoxicity in the SV-40 human uroepithelial cell line and increased expression of mutant p53 and COX-2 proteins.
Executive summary:

A single cell gel/comet assay in mammalian cells for detection of DNA damage was performed. Test substance treatment reduced cell viability in a dose-dependant manner. The test substance caused DNA damage on SV-HUC-1 cells. The report shows the expression level of mutant p53 and COX-2 analysis by immunocytochemistry analysis after treatment with the test substance in SV-HUC-1 cell lines. Test substance treatment increased mutant p53 and COX-2 proteins expression. Under the conditions employed in this study, test substance exposure resulted in cytotoxicity in the SV-40 human uroepithelial cell line and increased expression of mutant p53 and COX-2 proteins.