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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: NO OECD Guideline or GLP defined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Principles of method if other than guideline:
Ames Assay
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
3320-93-0
IUPAC Name:
3320-93-0
Details on test material:
content: 99.7% (analytical result)

Method

Target gene:
Ames test
Species / strain
Species / strain / cell type:
other: TA 1535, TA 100, TA 1537, TA 98 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Doses up to and including 500 µg/ plate.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, cumene hydroperoxide and 2-amino-anthracene

Results and discussion

Test results
Species / strain:
other: TA 1535, TA 100, TA 1537, TA 98 and TA 102
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:
valid

Applicant's summary and conclusion

Executive summary:

The test substance was initially investigated using the Salmonella/ microsome plate incorporation test for point mutagenic effects in doses of up to and including 5000 µg per plate on five Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537, TA 98 and TA 102.

Doses up to and including 500 µg per plate did not cause any bacteriotoxic effects: total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that 1581 µg per plate could not be used for assessment purposes. 5000 µg per plate could not be used for assessment. Substances precipitation occurred at the dose 1581 µg per plate and above.

The positive controls sodium azide, nitrofurantoin, 4 -nitro-1,2 -phenylene diamine, cumene hydroperoxide and 2 -aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.

Evidence of mutagenic activity of the test substance was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

Additionally an independent repeat with doses up to 1200 µg per tube after preincubation for 20 minutes at 37°C on the same Salmonella typhimurium strains was evaluated. Doses up to and including 150 µg per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that 1200 µg per tube could only be used to a limited extent for assessment purposes.

Evidence of mutagenic activity of the test substance was not seen.