p-phenylenediamine

Genetic toxicity: in vitro

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

Test material information

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.