Cumene

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Cumene

EC Number:

202-704-5

EC Name:

Cumene

Cas Number:

98-82-8

Molecular formula:

C9H12

IUPAC Name:

isopropylbenzene

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.