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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
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically defensible or guideline method was used, study conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
Principles of method if other than guideline:
Bibliography: Ames et al., Mut.Research. 31: 347-364, 1975
Appropriate positive controls included
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Carboxylic acids, di-, C4-6
EC Number:
271-678-5
EC Name:
Carboxylic acids, di-, C4-6
Cas Number:
68603-87-2
Molecular formula:
C5H8O4, C4H6O4, C6H10O4
IUPAC Name:
68603-87-2
Details on test material:
Sample idetification: AGS Mixture:
Adipic acid: 6-9%
Glutaic acid 30-35%
Succinic acid 8-11%
Nitric acid 0.5 - 3%
Lot: FIT-85-45,46,47; white solid powder

Method

Target gene:
Histidine auxotrothy
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 mix
Test concentrations with justification for top dose:
30, 100, 300, 1000, 3000 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Water
Positive controls:
yes
Positive control substance:
other: Sodium acide, 9-aminoacridine, 2-nitrofluorene, 2-anthramine

Results and discussion

Test results
Species / strain:
other: all strains tested
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: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Bacterial toxicity was investigated in a pilot experiment; no relevant colonies at 5000 µg/plate; high dose for main experiment: 3000µg/plate. All solvent and positive controls showed the expected results.

The results of the test article, AGS Mixture, were negative in strains TA 1535, 1537, 98 and 100 of S. aureus with and without metabolic activation at all doses tested (highest dose: 3000 µg/plate).

In the initial assay, strain 1538 exhibited an increase in mutant frequency at the hghest dose (2.5 fold above the concommitant control) without metaboilic activation. Two subsequent retests failed to confirm the initial obersation. Mean spontaneous revertants per plate TA1338 / control . Experiment without S9:

30, 100, 300, 1000, 3000, µg/plate / control

initial experiment: 13, 15, 15, 22, 35 / 14

Repeat 1: 6, 8, 5, 11, 21 / 12

Repeat 2: 12, 12, 9, 16, 11 /12

Overall the authors concluded that the test compound is not mutagenic

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

AGS is not nutagenic in the bacterial reverse mutation assay
Executive summary:

AGS is not nutagenic in the bacterial reverse mutation assay