Glutaric anhydride

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:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Glutaric anhydride

EC Number:

203-593-6

EC Name:

Glutaric anhydride

Cas Number:

108-55-4

Molecular formula:

C5H6O3

IUPAC Name:

glutaric anhydride

Test material form:

solid: crystalline

Results and discussion

Test results

Key result

Species / strain:

other: 4116=S. typhimurium TA 1535, TA 1537, TA1538, TA 98 and TA 100

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'.

Applicant's summary and conclusion

Conclusions:

Glutaric anhydride was not considered to be mutagenic in this screening test.

Executive summary:

Glutaric anhydride was tested for potential mutagenic activity using the Salmonella/microsome bacterial mutagenicity assay (Ames test). Test doses for the Ames test were chosen from data obtained in a preliminary study using strain TA100. Results of preliminary tests performed without an S9 metabolic activation system indicated that a concentration of 5 mg/plate of glutaric anhydride produced complete absence of growth. A slightly lower dose of 3 mg/plate allowed sparse growth of the bacterial lawn, but reduced the relative number of revertant colonies to approximately 4% of the concurrent control value. With S9, doses ranging from 10 to 50 mg/plate completely inhibited growth of the background lawn and a lower dose of 5 mg/plate allowed sparse growth, but reduced the number of revertant colonies to approximately 23% of the concurrent control value. On the basis of these results, five concentrations of glutaric anhydride were tested ranging from 0.03 mg/plate to 3 mg/plate without metabolic activation and from 0.1 to 5 mg/plate with S9 activation using triplicate cultures for each dose level for each bacterial strain. No mutagenic activity was observed with any of the five bacterial strains tested either with or without the presence of an Aroclor 1254-induced rat-liver S9 metabolic activation system. However, excessive treatment-related toxicity was Observed with the highest two to three dose levels tested. Thus, this study was repeated using an approximate 10-fold lower range of doses from 0.003 mg/plate to 0.3 mg/plate without metabolic activation and from 0.01 to 1 mg/plate with S9 activation. None of these dose levels produced evidence of treatment-related mutagenic activity either in the presence or absence of metabolic activation. Thus, glutaric anhydride was not considered to be mutagenic in this screening test.