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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. Restriction:

Data source

Reference
Reference Type:
grey literature
Title:
Salmonella testing results, CAS # 119-64-2, aliquot A43612
Author:
NTP (U.S. National Toxicology Program)
Year:
2004
Bibliographic source:
U.S. Department of Health and Human Services; 4 pp

Materials and methods

Principles of method if other than guideline:
Haworth et al. (1983). Environ. Mutagen. 5 (Suppl. 1), 3-142 (with minor modifications).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,2,3,4-tetrahydronaphthalene, aliquot A43612, no data on purity

Method

Target gene:
mutated gene loci responsible for histidine auxotrophy
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 100, TA 1535, TA 97, TA 98
Metabolic activation:
with and without
Test concentrations with justification for top dose:
0; 0.3; 1; 3; 10; 33; 100; 333 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Details on test system and experimental conditions:
Ames test
SYSTEM OF TESTING
- Metabolic activation system:  S9 from Aroclor 1254-induced Sprague-Dawley rats and Syrian hamsters
ADMINISTRATION: 
- Dosing: at least 5 doses, limited by toxicity or solubility or 10  mg/plate
- Number of replicates: 3
- Positive and negative control groups and treatment:    
solvent (DMSO) control and positive controls; no details
- Pre-incubation time: 20 minutes
Evaluation criteria:
CRITERIA FOR EVALUATING RESULTS:    
positive: reproducible, dose related increase in histidine-independent  (revertant) colonies in any strain   
equivocal: not dose related or not reproducible

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 100, TA 1535, TA 97, TA 98 (1st test) and S. typhimurium strains TA98 and TA100 and with Escherichia coli strain WP2 uvrA/pKM101 (2nd test)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative 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

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

1,2,3,4-tetrahydronaphthalene was not mutagenic in Salmonella typhimurium strains (Ames test).
Executive summary:

1,2,3,4-tetrahydronaphthalene (0.3 to 333 μg/plate) was not mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, or TA1535 when testing was conducted with or without induced rat or hamster liver metabolic activation enzymes. A second bacterial mutagenicity assay conducted with the same lot of tetralin (2 to 500 μg/plate) used in the 2‑year study showed no mutagenicity in S. typhimurium strains TA98 or TA100 or in Escherichia coli strain WP2 uvrA, with or without rat liver activation enzymes.