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Toxicological information

Genetic toxicity: in vitro

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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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Relative sensitivities of forward and reverse mutation assays in|Salmonella typhimurium
Author:
Skopek TR, Liber HL, Kaden DA, Thilly WG
Year:
1978
Bibliographic source:
Proc Natl Acad Sci (USA) 75: 4465-4469. Cited in: EU RAR (2002)
Reference Type:
secondary source
Title:
EU Risk Assessment Report Dimethyl Sulphate
Author:
European Chemicals Bureau
Year:
2002
Bibliographic source:
EU RAR, Volume 12. Luxembourg 2002

Materials and methods

Principles of method if other than guideline:
Ames test
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dimethyl sulphate
No further data

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
without
Metabolic activation system:
not applicable
Test concentrations with justification for top dose:
100, 200, 300 µM (12.6, 25.2, 37.8 µg/ml)
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 60 min
Plating was performed in triplicates, no metabolic activiation; no additional data

DETERMINATION OF CYTOTOXICITY
- Method: cell survival
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
in all strains evalueted
Cytotoxicity / choice of top concentrations:
other: 50% survivial at 100 mM
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Induction of test substance-induced His+ revertants was reported to be 2- to 30- fold over control for all strains used.

Applicant's summary and conclusion