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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

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
GLP compliance:
not specified
Type of assay:
bacterial forward mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
EC Number:
607-813-5
Cas Number:
25830-77-7
Molecular formula:
C13 H9 N O5
IUPAC Name:
2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
Test material form:
solid

Method

Details on test system and experimental conditions:
Mutagenicity:

Test compound was examined in the
Salmonella/microsome assay (Ames Test) for
mutagenic potential in the standard Salmonella
plate incorporation assay and in the
pre-incubation modification using seven tester
strains. The tests were carried out in the
presence and absence of phenobarbital-induced rat
liver homogenate (S-9) fraction in duplicate
assays.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
Based on the available information the substance is not classified
Executive summary:

Mutagenicity: Test compound was examined in the Salmonella/microsome assay (Ames Test) for mutagenic potential in the standard Salmonella plate incorporation assay and in the pre-incubation modification using seven tester strains. The tests were carried out in the presence and absence of phenobarbital-induced rat liver homogenate (S-9) fraction in duplicate assays.

Based on the available information the substance is not classified.