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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone
EC Number:
223-754-4
EC Name:
4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone
Cas Number:
4051-63-2
Molecular formula:
C28H16N2O4
IUPAC Name:
4,4'-diamino-1,1'-bianthracene]-9,9',10,10'-tetraone
Details on test material:
- Name of test material (as cited in study report): CAS name:[l,1'-Bianthracene]-9,9',10, 10'-tetrone, 4,4'-diamino
- Substance type: red powder
- Physical state: solid
- Analytical purity: 99,5%
- Impurities (identity and concentrations): water (ca 0.5%)
- Purity test date: no data
- Lot/batch No.: E 804112008
- Expiration date of the lot/batch: December 2023
- Stability under test conditions: stable
- Storage condition of test material: The substance was indicated to be stored in the airtight delivered plastic container in the darkness at room temperature

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
liver S9 mix from Delor 106 (mixture of PCBs) induced rats
Test concentrations with justification for top dose:
10, 100, 500, 1000, 2500 and 5000 microgramms/plate (TA 100)
50, 150, 500, 1500 and 5000 microgramms/plate (all other strains)
Vehicle / solvent:
water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Sodium azide, 4-nitro-o-phenylenediamine, 9-aminoacridine hydrochloride monohydrate, 2-aminofluorene, 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation)
Evaluation criteria:
The main criterion for evaluation of results was modified two-fold increase rule, its using is comparable with using of statistical methods. After this rule the result is positive, when reproducible dose-effect and/or doubling of ratio Rt/Rc is reached.
Statistics:
Dunkel V. C.,Chu K.C. (1980): Evaluation ofmethods for analysis ofmicrobial
mutagenicity assays, in The Predictive Value of Short-Term Screening Tests in Carcinogenicity Evaluation, Elsevier North-Holland Biomedical Press, 231 - 240
Claxton L. D. et al. (1987): Guide for the Salmonella typhimurium/mammalian microsome tests far bacterial mutagenicity, Mutat. Res. 189, 83 - 91

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
The test item precipitated on the plates. This did not hinder scoring.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative