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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2007
Bibliographic source:
IUCLID4 data set, 2007

Materials and methods

Test guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
no
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
EC Number:
259-224-4
EC Name:
Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
Cas Number:
54553-90-1
Molecular formula:
C10H6O8.C9H10N2
IUPAC Name:
benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix based on S9 fraction from Aroclor 1254 induced male Sprague Dawley rat liver
Test concentrations with justification for top dose:
0; 600; 3000; 5000 mg/l (+ S9) / 0; 50; 200; 400 mg/l (- S9)

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
CONTROLS:
The positive controls were functional.
The negative controls revealed low chromosomal aberration frequencies
(excluding gaps: 0 to 0.5 %; normal: 0 to 5 %).
PRECIPITATION CONCENTRATION: > 5000 mg/l
-------------------------------------------
MITOTIC INDEX AND CHROMOSOMAL ABERRATIONS:
-------------------------------------------
Concentration % M.I. % C.A.
-------------------------------------------
- Experiment # 1, without S9 (18 hours)
neg. control 7.0 0.0
50 mg/l 6.1 0.0
200 mg/l 7.0 0.0
400 mg/l 3.5 1.5
600 mg/l 2.2
0.03 mg/l MMC 5.2 13.0 *
-------------------------------------------
- Experiment # 1, with S9 (18 hours)
neg. control 6.8 0.5
600 mg/l 7.1 0.5
3000 mg/l 9.2 2.0
5000 mg/l 9.3 1.5
3 mg/l CP 2.5 38.0 *
-------------------------------------------
- Experiment # 2, without S9, 18 hours
neg. control 5.0 0.0
50 mg/l 4.7 1.5
200 mg/l 4.0 1.0
400 mg/l 4.8 1.0
0.03 mg/l MMC 5.4 20.5 *
-------------------------------------------
Experiment # 2, without S9, 28 hours
neg. control 7.6 0.0
400 mg/l 4.4 0.5
0.03 mg/l MMC 5.6 33.0 *
-------------------------------------------
- Experiment # 2, with S9, 18 hours
neg. control 5.3 0.5
600 mg/l 6.2 1.0
3000 mg/l 7.0 2.0
5000 mg/l 5.5 1.0
3 mg/l CP 2.0 26.5 *
-------------------------------------------
- Experiment # 2, with S9, 28 hours
neg. control 5.9 0.0
5000 mg/l 6.8 0.5
3 mg/l CP 8.2 19.5 *
-------------------------------------------
* indicates significance
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion