Registration Dossier
Registration Dossier
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EC number: 244-787-0 | CAS number: 22113-87-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals
- Author:
- Mortelmans K, Haworth S, Lawlor T, Speck W, Tainer B, Zeiger E
- Year:
- 1 986
- Bibliographic source:
- Environ Mutagen. 1986;8 Suppl 7:1-119
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Methylamine
- EC Number:
- 200-820-0
- EC Name:
- Methylamine
- Cas Number:
- 74-89-5
- IUPAC Name:
- methanamine
- Reference substance name:
- Monomethylamine
- IUPAC Name:
- Monomethylamine
- Details on test material:
- - Name of test material (as cited in study report): Monomethylamine
- Molecular formula (if other than submission substance): CH3-NH2
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat and hamster liver fraction
- Test concentrations with justification for top dose:
- At least 5 test concentrations up to 10 mg/plate: 0, 100, 333.3, 1000, 3333.3, 10000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:distilled water
- Vehicle(s)/solvent(s) used:DMSO
- Justification for choice of solvent/vehicle: for chemicals that were not soluble in water or soluble at low concentrations only
- Vehicle(s)/solvent(s) used:ethanol 95% or acetone
- Justification for choice of solvent/vehicle:for chemicals insoluble in water or DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- potassium chloride
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: TA1535, TA100
- Untreated negative controls:
- yes
- Remarks:
- potassium chloride
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine for TA98
- Untreated negative controls:
- yes
- Remarks:
- potassium chloride
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: TA97, TA1537
- Untreated negative controls:
- yes
- Remarks:
- potassium chloride
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hr - Evaluation criteria:
- 1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold;
2) nomutagenic response: when no increase in the number of revertants was elicited by the chemical;
3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity
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:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- 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
Monomethylamine was found non mutagenic under the test conditions.
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