Stoddard solvent

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Stoddard solvent

EC Number:

232-489-3

EC Name:

Stoddard solvent

Cas Number:

8052-41-3

Molecular formula:

C10H22

IUPAC Name:

stoddard solvent

Test material form:

liquid

Specific details on test material used for the study:

Stoddard solvent; boiling range, 157-204°C; 19% aromatics

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

With and without Aroclor induced rat liver S9

Test concentrations with justification for top dose:

0.001-5 µg/plate and 3.38-25 µl/ml

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: not stated

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 1103

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation)

DURATION
- Preincubation period: not applicable
- Exposure duration: 48 hours

NUMBER OF REPLICATES: duplicate test, each performed with triplicate plates

DETERMINATION OF CYTOTOXICITY
- Method: growth of bacterial lawn

Evaluation criteria:

For a substance to be considered positive, it should have induced a concentration-related and statistically significant increase in mutation rate in one or more starins of bacteria in the presence and/or absence of S9 in both experiments at sub-toxic concentrations. To be considered negative the number of induced revertants compared to spontaneous revertants should be less than two-fold at each concentration employed.

Statistics:

Methods recommended by the United Kingdom Environmental Mutagen Society and normally Dunnett's method of linear regression

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data

COMPARISON WITH HISTORICAL CONTROL DATA: vehicle control results said to be "within the normal range"

ADDITIONAL INFORMATION ON CYTOTOXICITY: no further data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

 

 

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results :negative
In a reliable study, performed according to OECD guideline 471, the Stoddard solvent did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels of 0.001-5 µg/plate and 3.38-25 µl/ml . This concentration was not cytotoxic.

Executive summary:

Interpretation of results :negative

In a reliable study, performed according to OECD guideline 471, the Stoddard solvent did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels of 0.001-5 µg/plate and 3.38-25 µl/ml . This concentration was not cytotoxic.