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Diss Factsheets

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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report of test chemical
Author:
OECD SIDS
Year:
2001
Bibliographic source:
OECD SIDS, 2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Genotoxicity was performed to determine the mutagenic nature of test chemical
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-2,4-dione
EC Number:
204-634-0
EC Name:
Pentane-2,4-dione
Cas Number:
123-54-6
Molecular formula:
C5H8O2
IUPAC Name:
2,4-Pentadione
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report):2,4-Pentandione- Molecular formula :C5H8O2- Molecular weight : 100.116 g/mol- Substance type:Organic- Physical state:Liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, 100, 1535, 1537 and 1538
Details on mammalian cell type (if applicable):
not specified
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
liver S9 mix produced from rats pretreated with Aroclor 1254
Test concentrations with justification for top dose:
not specified
Vehicle / solvent:
not specified
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Remarks:
not specified
Details on test system and experimental conditions:
not specified
Rationale for test conditions:
not specified
Evaluation criteria:
Revertants / plate (less than doubling)
Statistics:
not specified

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, 100, 1535, 1537 and 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: not specified

Applicant's summary and conclusion

Conclusions:
Test chemical did not induce revertants / plate (less than doubling) in S.typhimurium strains TA98, 100, 1535, 1537 and 1538 and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

AMES test was performed to determine the mutagenic nature oftest chemical. The study was perfomed using S.typhimurium strains TA98, 100, 1535, 1537 and 1538 both in the presence and absence of a metabolic activation system (liver S9 mix produced from rats pretreated with Aroclor 1254). The test material did not produce a statistically significant increase in the revertants / plate (less than doubling) thereby demonstrating no potential to induce gene mutations. Therefore,Test chemical did not induce revertants / plate (less than doubling) in S.typhimurium strains TA98, 100, 1535, 1537 and 1538 and hence it is not likely to classify as a gene mutant in vitro.