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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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, part of NTP/USA

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
preincubation assay, two sources of liver microsomes (from rat and hamster)
Principles of method if other than guideline:
acc. to Haworth et al. (1983): Environ. Mutagen. 5, Suppl. 1, 3-142
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hexadecylamine (No. 156 in publication)
- Substance type: organic
- Physical state: solid, waxy
- Analytical purity: 90 %
- Impurities (identity and concentrations): no data

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 100, TA 98 and TA 97
Metabolic activation:
with and without
Metabolic activation system:
Metabolic activation systems were derived from Arochlor-induced livers of male SD rats and male Syrian hamsters.
Test concentrations with justification for top dose:
0.3, 1.0, 3.0, 10.0, 33.0, and 100 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Remarks:
corresponds to vehicle control
Negative solvent / vehicle controls:
yes
Remarks:
+ DMSO
Positive controls:
yes
Positive control substance:
other: -S9: Sodium azide (TA1535, TA100); 9-aminoacridine (TA97); 4-nitro-o-phenylenediamine (TA98) // +S9: 2-aminoanthracene (all strains).
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation, agar plate

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days at 37 °C


NUMBER OF REPLICATIONS: 3


DETERMINATION OF CYTOTOXICITY
- relative total growth (background lawn)
Evaluation criteria:
Mutagenic (+) or weakly mutagenic (+w) if a reproducible, dose-related increase in revertants over the corresponding solvent controls in replicate trials was seen.
Questionable (?) if a reproducible increase in revertants did not meet the criteria of either "+" or "+w", or if single doses produced an increase in repeat trials.

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 33 µg/plate -S9 (see Appendix 2, p. 95)
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA1535, TA100, TA 98, TA 97 (preincubation assay)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative