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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The target chemical 3-oxoglutaric acid and the read across chemical belong to the same category; that of “dicarboxylic acid”. Both the chemicals share physico-chemical properties within an acceptable range as well as environmental fate properties and aquatic toxicity properties thereby qualifying for suitable read-across. In general, the most striking pattern across the two chemicals is their low toxicity profile.

Data source

Reference
Reference Type:
other: Authoritative data base
Title:
Study ID: 994718
Author:
NTP Database
Year:
2012
Bibliographic source:
NTP (National Toxicological Program)by Agency for Toxic Substances and Disease Registry; Division of Toxicology/Toxicology Information Branch, 1600 Clifton Road NE, E-29, Atlanta, Georgia 30333

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : glutaric acid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
10% & 30 % HLI; 10% & 30% RLI
Test concentrations with justification for top dose:
0 - 10000 ug/Plate
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
water
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

TA 100
Dose No Activation
(Negative)
No Activation
(Negative)
10% HLI
(Negative)
30% HLI
(Negative)
10% RLI
(Negative)
30% RLI
(Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0     
112 9.2 121 18.1 126 7 134 8.3 145 9.1 134 4.6
33     
        135 6.6     134 11.6    
100     
115 7 116 7.9 114 2.8 116 5.2 132 5.8 139 8.7
333     
97 1.3 108 10.7 112 10.4 130 15 139 8.5 138 3.4
1000     
99 13.5 94 4 116 6.6 132 5 132 10.8 122 11.6
3333     
112 8.3 95 7.1 97s 9.2 97s 5.2 83s 6.8 115 12.3
6666     
    101s 19                
10000     
17s 17.3         99x 9.3     101x 5
Positive Control 1000 39.4 778 25.1 896 43.7 631 21.6 366 9.9 366 19.4

TA 1535:

Dose No Activation
(Negative)
No Activation
(Negative)
10% HLI
(Negative)
30% HLI
(Negative)
10% RLI
(Negative)
30% RLI
(Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0     
4 1 8 2.3 5 1.2 4 0.3 8 1 9 0.3
33     
        7 1.2 8 2.3 8 2.2 10 2.6
100     
8 1.2 7 0.9 7 2.4 8 2.3 8 1.2 9 2
333     
7 1.7 4 1.5 8 1.5 8 0.9 9 1.5 10 1.5
1000     
5 0.6 7 1.3 7 2.7 11 3.8 6 1.5 7 0.3
3333     
9 0.3 4 1.5 7 0.9 8 0 5s 1.2 8 1.2
6666     
3 1.2 2 0.6                
Positive Control 1124 72.4 970 39.7 78 4.7 233 13.3 64 6.4 99 3

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Genetic toxicity in vitro was examined in Salmonella TA 100 & TA 1535 at dose concentration of 0 - 10000 ug/Plate showed negative result.
Executive summary:

Genetic toxicity in vitro was examined in Salmonella TA 100 & TA 1535 at dose concentration of 0 - 10000 ug/Plate showed negative result.