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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-06-03 to 1992-05-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Principles of method if other than guideline:
Mouse lymphoma assay, suspension plate, no further details
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,3,4-tetrahydronaphthalene
EC Number:
204-340-2
EC Name:
1,2,3,4-tetrahydronaphthalene
Cas Number:
119-64-2
Molecular formula:
C10H12
IUPAC Name:
1,2,3,4-tetrahydronaphthalene
Details on test material:
1,2,3,4-tetrahydronaphthalene from Chem Service Inc. (West Chester, Pennsylvania, USA), purity 98.2 %

Method

Target gene:
tymidin kinase gene
Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Metabolic activation system:
 Aroclor 1254-induced rat liver S9 mix
Test concentrations with justification for top dose:
-S9: 30-50 and 35-47.5 µg/ml;
+S9: 1-15 and 10-20 µg/ml
Vehicle / solvent:
 DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
 3-methylcholanthrene with S9-mix   Migrated to IUCLID6: without S9-mix
Details on test system and experimental conditions:
Mouse lymphoma assay
Metabolic activation system: Aroclor 1254-induced rat liver S9 mix
ADMINISTRATION: 
- Dosing:   
-S9: 30, 35, 40, 45, 50 µg/ml  
 +S9:  1, 2.5, 5, 10, 15 µg/ml  
follow-up -S9: 35, 40, 42.5, 45, 47.5 µg/ml   
follow-up +S9: 10, 12.5, 15, 17.5, 20 µg/ml  
solvent: DMSO
- Number of replicates: 2
- Positive and negative control groups and treatment:    
positive: ethylmethanesulfonate (-S9); 3-methylcholanthrene (+S9)   
negative: solvent and untreated
- Pre-incubation time: two-day expression period
Evaluation criteria:
CRITERIA FOR EVALUATING RESULTS: dose-dependent increase in mutant  frequency

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
ambiguous
Cytotoxicity / choice of top concentrations:
other: see Results
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
GENOTOXIC EFFECTS:  Initial study: 
- positive with and without metabolic activation
- validity questionable due to findings in controls
Follow-up study:
- negative without metabolic activation
- equivocal with metabolic activation (the only cultures exhibiting a  significant increase in mutant frequency had less than 10% total growth)
Controls:    Positive controls were as expected in both studies.   
Negative controls showed unacceptably high mutant frequencies in the  initial study and were as expected in the follow-up study.
CYTOTOXIC CONCENTRATION:
- Toxicity screening study:   Complete toxicity >= 100 µg/ml, almost complete at 50 µg/ml (-S9);   complete toxicity >= 50 µg/ml (+S9)
- Initial study:   "too toxic to clone" at 52 µg/ml (-S9) and 20 µg/ml (+S9)
- Follow-up study:    "too toxic to clone" at 50 µg/ml (-S9) and 22.5 µg/ml (+S9)
Remarks on result:
other: other: L5178Y TK+/-
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In a mouse lymphoma test tetrahydronaphthalene showed no relevant genotoxic effects.
Executive summary:

In a mouse lymphoma test, a negative result was obtained in the absence of a metabolic activation system (dose range 35-47.5 μg/ml), while with the addition of S-9 mix the test was equivocal (dose range 10-20 μg/ml): The only cultures exhibiting a significant increase in mutant frequency had less than 10 % total growth.