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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: other: preincubation method according to Ames, Mutat. Res. 31,347(1975); Maron, Mutat. Res.113,173(1983)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity Test Data of Existing Chemical Substances
Author:
JETOC (Jap. Chem. Ind. Ecolog. Toxicol. Inform. Center)
Year:
2000
Bibliographic source:
JETOC (Jap. Chem. Ind. Ecolog. Toxicol. Inform. Center)Suppl. 2, 33-39, 71, 170-171.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: according to Ames, Mutat. Res. 31,347(1975); Maron, Mutat. Res.113,173(1983)
Principles of method if other than guideline:
Preparation of S9 Fraction:
Male Sprague-Dawley rats were used for the preparation of liver fractions. Sodium phenobarbital and 5,6-benzofravone were used as an inducer of the rat metabolic activation system. Sodium phenobarbital was injected intraperitoneally into the rats 4 days before killing and 1, 2 and 3 days before killing 5,6-benzoflavone was injected intraperitoneally; from these rats liver S9 fraction was prepared according to Ames et al. (1975), Methods for detecting carcinogens and mutagens in the Salmonella /mammalian microsome mutagenicity test, Mutat. Res. 31, 347-364. S9 was dispensed into freezing ampules and stored at -80°C. Once the stock S9 had been thawed, remained S9 was not reused.

Evaluation criteria:
Twohold rule was used for data evaluation. the chemicals are considered to be mutagenic when dose-related increase in revertant colony count is observed and the number of revertant colonies per plate with the test substance is more than twice that of the negative control (solvent control) and when a reproducibility of test result is observed.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dicyclohexylamine
EC Number:
202-980-7
EC Name:
Dicyclohexylamine
Cas Number:
101-83-7
Molecular formula:
C12H23N
IUPAC Name:
N-cyclohexylcyclohexanamine
Details on test material:
purity >99%

Method

Target gene:
Salmonella typhimurium TA98, TA100, TA1535, TA1537, Escherichia coli WP2uvrA/pKM101
Test concentrations with justification for top dose:
(1) 0, 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate in DMSO
(2) 0, 78.1, 156, 313, 625, 1250, 2500, 5000 µg/plate in DMSO
Vehicle / solvent:
DMSO

Results and discussion

Test resultsopen allclose all
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

negative

Applicant's summary and conclusion