Methyl 3-[3-(2H-benzotriazol-2-yl)-4-hydroxy-5-(2-methyl-2-propanyl)phenyl]propanoate

Genetic toxicity: in vitro

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

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP and OECD guideline compliant study with four strains.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Four strains tested, as required by outdated version of OECD testing guideline

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

400-820-2

EC Name:

-

Cas Number:

84268-33-7

Molecular formula:

C20 H23 N3 O3

IUPAC Name:

methyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate

Details on test material:

- Physical state: solid
- Analytical purity: purified
- Lot/batch No.: Z 288/1U

Method

Target gene:

his

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:

with Aroclor 1254 induced rat liver S9-mix

Test concentrations with justification for top dose:

0.1 - 5000 µg/0.1 ml for toxicity test
20 - 5120 µg/0.1 ml for the mutagenicity test

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dimethylformamide

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see table 1

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

The test substance is generally considered to be nonmutagenic if the colony count in relation to the negative control is not doubled at any concentration.

Statistics:

the arithmetic mean was calculated

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and 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 examined

Positive controls validity:

valid

Additional information on results:

In order to confirm the results the experiments were repeated.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

In the experiments performed without and with microsomal activation, comparison of the number of histidine-prototrophic mutants in the controls and after treatment revealed no marked differences. At the concentrations of 320 µg/0.1 ml and above the substance precipitated in soft agar.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative