Registration Dossier
Registration Dossier
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EC number: 500-281-4 | CAS number: 98362-33-5
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
- 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:
- 1 986
- 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 substance name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
- EC Number:
- 500-281-4
- EC Name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
- Cas Number:
- 98362-33-5
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of neodecanoic acid oxiranylmethyl ester and 4-methylbenzenesulfonic acid
- Reference substance name:
- Copolymer of neodecanoic acid oxiranylmethyl ester and 4 -methylbenzenesulfonic acid
- IUPAC Name:
- Copolymer of neodecanoic acid oxiranylmethyl ester and 4 -methylbenzenesulfonic acid
- Details on test material:
- not reported
Constituent 1
Constituent 2
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.
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