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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1997
Deviations:
yes
Remarks:
only four strains tested
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
EC Number:
224-166-0
EC Name:
2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
Cas Number:
4221-80-1
Molecular formula:
C29H42O3
IUPAC Name:
2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction of liver from rats induced with Aroclor 1254.
Test concentrations with justification for top dose:
5 µg/0.1 mL, 15 µg/0.1 mL, 45 µg/0.1 mL, 135 µg/0.1 mL, 405 µg/0.1 mL
Vehicle / solvent:
- Vehicle/solvent used: Acetone
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Acetone
True negative controls:
no
Positive controls:
yes
Remarks:
for details see table below
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar

DURATION
- Exposure duration: The plates were incubated for about 48 hours at 37 °C in darkness.

NUMBER OF REPLICATIONS: Three Petri dishes were prepared per strain and per group.

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, number of revertants

POSITIVE CONTROLS
WITHOUT S9
TA 1535: N-methyl N'-nitro-N-nitrosoguanidine; 3 and 5 µg/0.1 mL phosphate buffer
TA 1537: 9(5)aminoacridine hydrochloride monohydrate; 25, 50 and 100 µg/0.1 mL DMSO
TA 98: daunoblastin; 2,5, 5 and 10 µg/0.1 mL phosphate buffer
TA 100: 4-nitroquinoline-N-oxide; 0.0625, 0.125 and 0.25 µg/0,1 mL phosphate buffer
WITH S9
TA 1535: cyclophosphamide; 100 and 250 µg/0.1 mL phosphate buffer
Evaluation criteria:
The test substance was considered to be non-mutagenic if the colony count in relation to the negative control was not doubled at any concentration.
Statistics:
When the colonies had been counted, the arithmetic mean was calculated.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the highest concentration the substance precipitated in soft agar.

Applicant's summary and conclusion

Conclusions:
No evidence of the induction of point mutations by the test article or by the metabolites of the substance formed as a result of microsomal activation was detectable in the strains of S. typhimurium used in these experiments.