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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
publication
Title:
Salmonella mutaginicity tests: II. Results from the testing of 270 chemicals
Author:
Mortelmans K, Haworth St, Lawlor T, Speck W
Year:
1986
Bibliographic source:
Environ. Mutagen. 8, Suppl. 7, 1-119

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Preincubation protocoll
GLP compliance:
not specified
Type of assay:
other: Salmonella/microsome assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexylamine
EC Number:
203-629-0
EC Name:
Cyclohexylamine
Cas Number:
108-91-8
Molecular formula:
C6H13N
IUPAC Name:
cyclohexanamine
Details on test material:
purity 98 %

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Additional strain / cell type characteristics:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with and without
Metabolic activation system:
S9-mix form male Sprague-Dawley rats and from male Syrian hamsters , both induced with Aroclor 1254
Test concentrations with justification for top dose:
0, 33, 100, 333,1000, 3333, 10000 µg/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
other: potassiumchloride
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine, sodium azide, 4-nitro-o-phenylenediamine, 2-aminoanthracene
Details on test system and experimental conditions:
preincubation protocoll
Evaluation criteria:
mutagenic response: a dose related reproducible increase in the numger of revertants over the background even if the increase was less than 2-fold
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 98, TA 97, TA 100, TA 1535, TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: Salmonella typhimurium TA 98, TA 97, TA 100, TA 1535, TA 1537
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion