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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: Comparable to guideline study with acceptable restrictions: Documentation limited, but individual revertant counts are available.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1986
Reference Type:
publication
Title:
Effectiveness of Salmonella strains TA 100, TA102 and TA104 for detecting mutagenicity of some aldehydes and peroxides .
Author:
Dillon D, Combes R and Zeiger E
Year:
1988
Bibliographic source:
Mutagenesis 134, 19-26 (1988)

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Preincubation method with and without metabolic activation from rat + hamster (strains: TA 97, TA98, TA 100, TA 1535, TA 1537), according to Haworth S et al.: Environ. Mutagen. 5, Suppl. 1, 3-142 (1983)
GLP compliance:
no
Remarks:
: published literature study
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 99 %
- Other: from Fluka

Method

Target gene:
Not documented
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA97, TA1535, TA1537
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S-9 fraction prepared from male Syrian hamster and male SD rat liver
Test concentrations with justification for top dose:
Up to 10000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: TA 1535 and TA 100
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
Migrated to IUCLID6: TA 98
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Migrated to IUCLID6: TA 97 and TA 1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

NUMBER OF REPLICATIONS: 3

Evaluation criteria:
A mutagenic response: dose-related, reproducible increase in the number of revertants over background,
a non-mutagenic response: no increas ein the number of revertants was elicited by the chemical
questionable response: whn there is an absence of clear-cut dose-related increase in revertants.
Statistics:
Not documented

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA97, TA1535, TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not applicable
Positive controls validity:
not specified
Additional information on results:
No information provided
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No further information

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The results of this study indicate that no mutagenic activity was found up to the high concentration of 10 mg/plate n-butyraldehyde. The result is considered reliable.
Executive summary:

In a comprehensive screening programme ( National Toxicology Program, NTP) using the preincubation variant with Salmonella TA 98, TA 97, TA 100, TA 1535, TA 1537 with and without metabolic activation from two liver sources (rat and hamster), no mutagenic activity was found up to the high concentration of 10 mg/plate n-butyraldehyde. The result is considered reliable.