Isoalkanes, C17 -C22 linear and branched

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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

Justification for type of information:

Performed 1984 to guidelines appropriate to that date
Considered scientifically valid and described in sufficient details

Data source

Reference

Reference Type:

publication

Title:

Lack of mutagenic activity of white spirit

Author:

B Gochet, C de Meester, A Lonard
Gh Deknudt

Year:

1984

Bibliographic source:

Int Arch Occup Environ Health ( 1984) 53:359-364

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

Performed before full validation of method type

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

White mineral oil (petroleum)

EC Number:

232-455-8

EC Name:

White mineral oil (petroleum)

Cas Number:

8042-47-5

Molecular formula:

C15 - C50

IUPAC Name:

White mineral oil

Test material form:

liquid

Specific details on test material used for the study:

Test material described as < 15% aromatic linear and branched hydrocarbons, boiling up to 190 C
The boiling point indicated C10 - C20

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

S. typhimurium, other: 1530

Metabolic activation:

with and without

Metabolic activation system:

59 mix ( 50 i/plate) from Aroclor 1254 pretreated rat livers

Test concentrations with justification for top dose:

Top dose 10 ul per plate used. Cytotoxicity was seen in preliminary work at 100 ul and in some replicates, also seen at 10 ul

Vehicle / solvent:

No for direct incorporation method
Pre-incubation replicates used ethanol as solvent,

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

no

Positive controls:

other: Historical

Positive control substance:

not specified

Details on test system and experimental conditions:

Solvent used only for pre-incubation replicates

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

other: historical

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

other: historical

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

other: historical

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

other: historical

Test results 5

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

other: historical

Test results 6

Species / strain:

S. typhimurium, other: 1530

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

other: historical

Additional information on results:

Bacterial strains were supplied by Dr Ames and results compared with historical positive results obtained for each strain

Applicant's summary and conclusion

Conclusions:

The work was part of primary research into low-aromatic hydrocarbons with the direct support of Dr Ames in the development of specific methods to invistigate reverse gene mation in bacterial cultures.