Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Assessment of the genotoxic potential of unleaded gasoline and 2,2,4-trimethylpentane in human lymphoblasts in vitro.
Author:
Richardson, K. et al.
Year:
1986
Bibliographic source:
Toxicol Appl Pharmacol 82: 316-322

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
yes
Remarks:
- using microtiter plates
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
2,2,4-trimethylpentane
EC Number:
208-759-1
EC Name:
2,2,4-trimethylpentane
Cas Number:
540-84-1
IUPAC Name:
2,2,4-trimethylpentane
Details on test material:
- Name of test material (as cited in study report): 2,2,4-trimethylpentane (TMP; isooctane)
- Analytical purity: no data

Method

Target gene:
thymidine kinase
Species / strain
Species / strain / cell type:
human lymphoblastoid cells (TK6)
Details on mammalian cell type (if applicable):
- Type and identity of media: RPMI 1640 medium supplemented with 15% heat-inactivated horse serum

Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
with Aroclor induced-rat liver homogenate
Test concentrations with justification for top dose:
5 % v/v TMP in DMEM medium, administered undiluted or as 50 % (1:1 saturated to normal medium)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMEM medium
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
with and without S9
Negative solvent / vehicle controls:
yes
Remarks:
DMEM medium
Positive controls:
yes
Remarks:
for S9 activated cultures
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: 15 µM
Untreated negative controls:
yes
Remarks:
with and without S9
Negative solvent / vehicle controls:
yes
Remarks:
DMEM medium
Positive controls:
yes
Remarks:
for non-activated cultures
Positive control substance:
ethylmethanesulphonate
Remarks:
Migrated to IUCLID6: 0.2 mM
Details on test system and experimental conditions:
see "any other information on materials and methods"

Results and discussion

Test results
Species / strain:
human lymphoblastoid cells (TK6)
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
TMP did not induce significant increases in the mutation frequency at the thymidine kinase locus.
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Cell survival in TMP-saturated medium with and without metabolic activation was greater than 50-60 %.
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
The elevated mutation frequencies of positive control compounds were as expected.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cell survival in positive control treated cultures was 40 or 30% for benzo(a)pyrene and EMS, respectively
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Based on the study design there is no incidence of increased genetic toxicity caused by the test substance.
Executive summary:

Based on the study design there is no incidence of increased genetic toxicity caused by the test substance.