3-oxoglutaric acid

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Glutaric acid

EC Number:

203-817-2

EC Name:

Glutaric acid

Cas Number:

110-94-1

IUPAC Name:

glutaric acid

Details on test material:

- Name of test material : glutaric acid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 2

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 results

Test results 1

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

Test results 2

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.