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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Principles of method if other than guideline:
Chromosome aberration test with CHL/IU cells
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Reference substance name:
1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone
EC Number:
255-460-7
EC Name:
1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone
Cas Number:
41611-76-1
IUPAC Name:
1,4-bis[(2-ethyl-6-methylphenyl)amino]-9,10-anthraquinone
Details on test material:
purity: 99.7 %;
unknown components (3 components) and water: 0.3%

Method

Species / strain
Species / strain / cell type:
mammalian cell line, other: CHL/IU
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
concentration [mg/ml] : 0.010, 0.020, 0.039, 0.078, 0.156, 0.313, 0.625, 1.250, 2.500, 5.000
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: MMC treatment group and B[a]P treatment group

Results and discussion

Test results
Species / strain:
mammalian cell line, other: CHL/IU
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
cytotoxicity was not recognized in the treatment with and without metabolic activation, 5 mg/mL was set as the highest concentration in each treatment condition
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: CHL/IU
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Number of chromosomal aberrant cells (structural aberrant cells and polyploid cells) did not increase in the treatment without or with metabolic activation. Number of chromosomal aberrant cells increased in the positive control group (MMC treatment group and B[a]P treatment group except for the treatment without S9Mix with metabolic activation) and, therefore, these results showed that the test was conducted appropriately.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

A Chromosome aberration test with CHL/IU cells was conducted with Macrolex RLW Tr.in concentrations up to 5 mg/l.

The number of chromosomal aberrant cells (structural aberrant cells and polyploid cells) did not increase in the treatment without or with metabolic activation. Number of chromosomal aberrant cells increased in the positive control group (MMC treatment group and B[a]P treatment group except for the treatment without S9Mix with metabolic activation) and, therefore, these results showed that the test was conducted appropriately.

Based on the above results, it was judged that the test substance did not have the ability to induce chromosomal aberration.Macrolex RLW Tr. was negative in the CA Test.