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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from Kodak Laboratory Chemicals
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-tert-butylhydroquinone
EC Number:
217-752-2
EC Name:
2-tert-butylhydroquinone
Cas Number:
1948-33-0
Molecular formula:
C10-H14-O2
IUPAC Name:
2-tert-butylbenzene-1,4-diol
Details on test material:
- Name of test material: 2-tert-butylhydroquinone- Molecular formula: C10H14O2- Molecular weight: 166.22- Substance type: Organic- Physical state: Solid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1537
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
RAT, LIVER, S-9, AROCLOR 1254
Test concentrations with justification for top dose:
2-tert-butylhydroquinone (TBHQ) was tested in the Ames bioassay at levels upto 13.9 mg/L (0.450 mg/plate) without S-9 activation 82.3 mg/L (2.7 mg/plate) with S-9 activation.
Vehicle / solvent:
Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
With S9 activation
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Without S9 activation for S. typhimurium TA 1535
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Without S9 activation for S. typhimurium TA 1537
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: picrolonic acid
Remarks:
Without S9 activation for S. typhimurium TA 1538
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: ICR-191
Remarks:
Without S9 activation for S. typhimurium TA 98
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Without S9 activation for S. typhimurium TA 100

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
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
Species / strain:
S. typhimurium TA 1537
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
Species / strain:
S. typhimurium TA 1538
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
Species / strain:
S. typhimurium 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
Species / strain:
S. typhimurium TA 100
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:
Without the metabolic mixture, the 50% population survival dose was observed to be between 31 and 9.8 mg/L.A significant decrease in 2-tert-butylhydroquinone (TBHQ) toxicity was observed in the presence of the S-9 metabolic mixture with 50% population survival occurring at between 30.5 and 96.3 mg/L.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

In the studies reported here, TBHQ was tested in the Ames bioassay at levels upto 13.9 mg/L (0.450 mg/plate) without S-9 activation 82.3 mg/L (2.7mg/plate) with S-9 activation. The maximum concentrations used in these studies resulted in reduced viability of the test organisms, indicating that TBHQ was being tested at biologically significant concentrations. The difference in maximum test concentrations as a function of the presence of S-9 indicates that the metabolite(s) of TBHQ formed by microsomal enzymes in the s-9 have less biological impact on the test organism than TBHQ itself. In the Ames bioassay , no TBHQ- related increases in revertants were noted in any test strain either with or without S-9 liver enzymes. HQ was negative when tested in the standard Ames test in five strains of Salmonella typhimurium , both with and without rat liver S-9 microsomal activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negative2-tert-butylhydroquinone (TBHQ) was negative when tested in the standard Ames test in five strains of Salmonella typhimurium,both with and without rat liver S-9 microsomal activation.
Executive summary:

In the Ames bioassay , no 2-tert-butylhydroquinone (TBHQ)- related increases in revertants were noted in any test strain either with or without S-9 liver enzymes. 

2-tert-butylhydroquinone (TBHQ) was negative when tested in the standard Ames test in five strains of Salmonella typhimurium,both with and without rat liver S-9 microsomal activation.