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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to guideline standard in context of National Toxicology Program with detailed description

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
; Strains TA 102 with AT base pair not tested
GLP compliance:
yes
Remarks:
Batelle Toxicology Northwest (Richland, WA)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cumene

- Substance type:
- Physical state: colorless liquid with a sharp, penetrating, aromatic odour
- Analytical purity: 99.9% peak area
- Impurities (identity and concentrations): No impurities >0.05% peak area detected
- Purity test date: Not specified
- Lot/batch No.: Lot 200556852
- Expiration date of the lot/batch: No data
- Stability under test conditions: stable over the test period, no degradation of bulk chemical was detected

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97, TA 98, TA100, and TA 1535
Metabolic activation:
with and without
Metabolic activation system:
S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver)
Test concentrations with justification for top dose:
0, 1, 3, 10, 33, 100, 166 and 333 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: no data
Controls
Positive controls:
yes
Remarks:
9-aminoacridine, sodium azide, 4-nitro-o-phenyldiamine, 2-aminoanthracene (for all strains with metabolic activation)
Positive control substance:
other:
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 20 min
- Expression time (cells in growth medium): 2 days

NUMBER OF REPLICATIONS: 2 (For tests with S9, first trial with 10%. if negative, second trial 30%)

NUMBER OF CELLS EVALUATED: three plates

DETERMINATION OF CYTOTOXICITY
- Method: not specified

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97, TA 98, TA100, and TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(at cencentrations >= 100 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Cumene (1 to 333 μg/plate) was not mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, or TA1535 when tested with and without induced rat or hamster liver S9 activation enzymes.

Applicant's summary and conclusion

Conclusions:
Cumene was not mutagenic in S. typhimurium strain TA97, TA98, TA100, or TA1535, when tested with and without liver S9 activation enzymes.
Executive summary:

Four strains of S.tyhimurium were tested up to concentrations of 333 µg/plate cumene. No mutagenicity was observed neither without nor with activation from S9 liver enzymes.