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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: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Not reported
Deviations:
not applicable
Principles of method if other than guideline:
The study was conducted according to 'Mutation Research 31, 347 - 364 (1975)'


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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Comperlan 100
- Analytical purity: 100 %

Method

Target gene:
Not reported
Species / strain
Species / strain / cell type:
other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
Details on mammalian cell type (if applicable):
Type and identity of media: Agar plates
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Postmitochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S-9 mix)
Test concentrations with justification for top dose:
4, 20, 100, 500 and 2500 µg/plate test material per plate
Vehicle / solvent:
No data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Remarks:
None
Details on test system and experimental conditions:
No data
Evaluation criteria:
No data
Statistics:
Not reported

Results and discussion

Test results
Species / strain:
other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
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:
not specified
Additional information on results:
None
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Under the test conditions, amides, C12-18 (even-numbered) and C18-unsatd., N-hydroxyethyl was found to be non-mutagenic
Executive summary:

A study was conducted to evaluate the genotoxic potential of amides, C12-18 (even-numbered) and C18-unsatd., N-hydroxyethyl in the Ames test. Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 were treated with the test substance using the Ames plate incorporation method at up to five dose levels (4, 20, 100, 500 and 2,500 µg/plate test material per plate) both with and without metabolic activation. Amides, C12-18 (even-numbered) and C18-unsatd., N-hydroxyethyl was found to be non-mutagenic under the conditions of this test