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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
data is from publication.

Data source

Reference
Reference Type:
publication
Title:
mutagenicity and toxicity studies of p-phenylenediamine and its derivatives;
Author:
Chung,kt
Year:
1995
Bibliographic source:
toxicol. Lett.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
mutagenicity and toxicity studies of test substance and its derivatives were evaluated for its mutagenic potential.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
other: TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
RAT, LIVER, S-9, AROCLOR 1254
Test concentrations with justification for top dose:
1-3000 UG/PLATE
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
Method: PREINCUBATION
Evaluation criteria:
The plates were observed for histidine revertent mutant colonies.

Results and discussion

Test results
Species / strain:
other: TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
The test substance was evaluated for its mutagenic potential in Salmonella typhimurium TA 98 and TA 100 both in the presence and absence of metabolic activation. The test result was considered to be non-mutagenic both in the presence and absence of metabolic activation.
Executive summary:

The test substance was evaluated for its mutagenic potential in Salmonella typhimurium TA 98 and TA 100 both in the presence and absence of metabolic activation. The test substance was exposed to Salmonella typhimurium at the concentration of 1-3000µg/plate in the presence and absence of metabolic activation. No mutagenic effect were observed. Therefore the test substance was considered to be non-mutagenic both in the presence and absence of metabolic activation. Hence the substance cannot be classified as mutagenic in vitro.