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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented publication, acceptable for assessment (publication in german)

Data source

Reference
Reference Type:
publication
Title:
Zur Toxikologie zweier haeufig nachgewiesener MVOCs: 1-Octen-3-ol und 3-Methyl-l-butanol.
Author:
Seidel HJ and Plappert U
Year:
1999
Bibliographic source:
Umweltmed Forsch Prax 4: 285-288

Materials and methods

Principles of method if other than guideline:
The study was conducted according to the method described by Bradley M O et al. (1981). Mutat. Res. 87: 81-142.
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-methyl-1-butanol
- source: Fluka

Method

Target gene:
HPRT
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-treated rat liver S9-mix
Test concentrations with justification for top dose:
0, 45.5, 455, 1820, 4550, 6370 µg/ml
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO (1% maximal concentration)
- Justification for choice of solvent/vehicle: was shown to produce no genetic toxicity effect
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
cyclophosphamide
Remarks:
with metabolic activation

Migrated to IUCLID6: 0.05 mM
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
without metabolic activation

Migrated to IUCLID6: 0.5 mM
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: 2000000 cells overnight in 10 ml medium
- Exposure duration: 2 hours
- Expression time (cells in growth medium): 4 aliquots of 250 cells for 7 days; the plating efficiency 1 (PE1) was determined at the end of the expression time.
- Selection time (if incubation with a selection agent): 5 aliquots of 200000 cells in 6-thioguanine-containing medium (10µg/ml) for 6 days; the plating efficiency 2 (PE2) was determined at the end of the selection time.

SELECTION AGENT (mutation assays): 6-thioguanine

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
Evaluation criteria:
The test substance was classified as mutagen if the spontaneous mutation rate was 3-fold higher than the control. The relative mutation frequency was the fraction of mutant colonies at "plating effeciency 2" (PE2).

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
cytotoxicity from 500 µg/ml onwards; 700 µg/ml caused complete cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
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