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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, guideline comparable study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Mutation screening in S. typhimurium and S. cerevisae
GLP compliance:
no
Remarks:
: study pre-dates GLP
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test material is described as a colourless liquid

Method

Target gene:
Reversion to histidine independence (S. typhimurium)
Species / strainopen allclose all
Species / strain / cell type:
other: S. typhiumurium TA98, TA100, TA1535, TA1575, TA1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
Saccharomyces cerevisiae
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Male Sprague-Dawley rat Arochlor 1254-induced liver S9 fraction
Test concentrations with justification for top dose:
The substance was tested in a range of concentrations ( 0.1-500 µl per plate), dissolved in distilled water.
Vehicle / solvent:
water or DMSO (both known to be nonmutagenic)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
distilled water
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: For non activation assays the following substances were used as positive controls; Methylnitrosoguanidine, 2-Nitrofluorene (NF) and Quinacrine mustard (QM). For the activation assays; 2-Anthramine, 2-Acetylaminofluorene and 9-Aminoquinoline
Details on test system and experimental conditions:
The plates were incubated for 48 hours at 37 deg C.
Evaluation criteria:
The number of colonies on each plate were counted and recorded.
Statistics:
None stated

Results and discussion

Test resultsopen allclose all
Species / strain:
other: S. typhimurium TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
All tests conducted with/without a metabolic system were negative.
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
The compound was toxic to the strains TA-1535, TA-1537, TA-1538 and TA-100 at 5 µL per plate.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
Saccharomyces cerevisiae
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
All tests conducted with/without a metabolic system were negative.
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Slight toxicity was observed at 5µL per plate with the strain D4.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
No further information
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test compound was examined for mutagenic activity in a series of in vitro microbial assays employing Salmonella and Saccharomyces indicator organisms. The compound was tested directly and in the presence of liver microsomal enzyme preparations from Aroclor induced rats. The compound was tested over series of concentrations. The compound was toxic to the strains TA-1535, TA-1537, TA-1538 and TA-100 at concentration of 5µL per plate and higher. Slight toxicity was observed at 5 µL per plate with the strain D4. All the tests conducted with/without a metabolic system were negative for mutagenic activity. In conclusion, the test compound did not demonstrate any mutagenic activity in any of the assays conducted.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test compound did not demonstrate any mutagenic activity in any of the assays conducted
Executive summary:

The test substance was investigated for mutagencity in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538; and in Saccharomyces cerevisae strain D4. Assays were performed using five concentrations of between 0.001 -5 ug/plate in the presence and absence of an exogenous metabolic acitvation system (Arochlor 1254 -induced male Sprague-Dawley rat liver S9 fraction). No evidence of mutagenicity was seen under the conditions of this study; toxicity was seen at the higher concentrations of the test material. Positive control compounds (MNNG, 2 -nitrofluorene, quinacrine mustard, 2 -anthramine, 2 -AAF and 8 -aminoquinoline) confirmed the sensitivity of the assay and the efficacy of the S9 fraction.