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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
Study period:
1986-01-29 to 1986-02-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions: TA 102 or E.coli WP2 were not tested,

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Principles of method if other than guideline:
Ames BN et al. (1975). Mutat. Res. 31, 347-364
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
not reported

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Arochlor induced rat S9 fraction
Test concentrations with justification for top dose:
10, 25, 50, 100, 200, 250, 1000, 5000 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
no
Positive controls:
other: except simultaneous test of several substances  including one positive result
Details on test system and experimental conditions:
Type: Ames test
ADMINISTRATION: 
- Number of replicates: 2
- Application: Solvent dimethyl sulfoxide (CAS No. 67-68-5)
- Positive and negative control groups and treatment:    
Negative: Blank   
Positive: None (except simultaneous test of several substances  including one positive result)
- Incubation: 4 days
Evaluation criteria:
CRITERIA FOR EVALUATING RESULTS:    Mutagenic effects (i.e  ratio of revertant rates treated/control >= 2) 

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
with metabolic activation, depending on strain, see results for details
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Additional information on results:
no further information
Remarks on result:
other: other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

CYTOTOXIC CONCENTRATION: none

GENOTOXIC EFFECTS: 

without metabolic activation: none with metabolic activation:   TA 100: >= 50 µg/plate
  TA 1535: >= 25 µg/plate TA 98: none TA 1537: none TA 1538: none

Applicant's summary and conclusion

Conclusions:
The mutagenic effect in the in vitro bacterial mutagenicity test is induced by not reacted 2,3-epoxypropyl neodecanoate, which is mutagenic in vitro.
Executive summary:

Under the conditions employed in the Salmonella reverse mutation assay,

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid

was mutagenic with metabolic activation in strain TA1535 at doses higher 25 ug/plate and in strain TA100 at doses higher than 50 ug/plate.

However, the mutagenic effect in the in vitro bacterial mutagenicity test is induced by not reacted 2,3-epoxypropyl neodecanoate, which is mutagenic in vitro.